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Pharmamel is a biotechnological company that emerged as a spin-off from the University of Granada.

The expertise stems from over 30 years of biomedical research applying melatonin in various disease models. As a result of clinical outcomes in phase II for indications such as Sepsis and COVID-19 (extendable to other viral processes), the company has a drug candidate in phase IIb/III.

82 remaining days
207 investors
Investment achieved
1.097.967€
Target
2.000.000€
Invested
54.9%
64% COMMITTED ? Amount of committed pre-campaign investments in the form of reservations or signed letters of intent.
COMMITTED : 189.981,00
1.097.967
54.9% INVESTED
Maturity

Premarket/clinical phase

Premoney valuation

37.000.000

Estimated exit

2026

Sector

Biotechnology

Equity offered

7.5%

Minimum investment

1.000

Equity L
Tax deduction
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Overview: Pharmamel

Valuation 37.000.000
Estimated return x10
% Offered 7.5%
Estimated exit 2026
The company

Pharmamel, S.L. is a research and development biotechnological company whose mission is to develop and bring to market innovative drugs based on melatonin and its high antioxidant and anti-inflammatory properties for application in pathologies associated with inflammation, oxidative stress, and mitochondrial damage.

Among these pathologies is sepsis, an exaggerated immune system response to infection caused by bacteria and viruses. This response triggers the multiorgan dysfunction syndrome, the leading cause of patient mortality. Recent global information on sepsis indicates the existence of over 50 million people worldwide with sepsis, resulting in 12-15 million deaths (25-30%).

This situation is increasing by 1.5% annually. Moreover, many surviving patients experience significant complications for the rest of their lives. The estimated healthcare expenditure for this pathology is around $30,000 per sepsis patient in the USA and equivalent in the EU.

Currently, there is no specific treatment for sepsis. The World Health Organization calls on all countries to research a drug to prevent and treat sepsis.

In this context, Darío Acuña-Castroviejo and Germaine Escames, professors of Physiology at the University of Granada, have worked on animal models of sepsis to assess the antiseptic capacity of melatonin in injectable solution. Their results endorse melatonin’s ability to counteract the exaggerated immune system response in sepsis, reducing the cytokine storm it produces, mitigating oxidative stress caused by inflammation, and rescuing mitochondrial function to maintain proper energy production in cells. These effects translate into reducing the severity of sepsis and even rescuing septic animals from the terminal phase of septic shock.

Given these results and the potential therapeutic use of melatonin injectables in patients, both researchers delved into the mechanisms of action of melatonin in experimental sepsis. They identified molecular targets related to its therapeutic effect, and conducted preclinical studies, including melatonin toxicity, dose-response effects, and melatonin bioavailability, among other studies.

Furthermore, the human equivalent dose was identified to translate the benefits found with melatonin in experimental animals to human clinical practice.

All these results led us to first patent the formulation and application of the melatonin injectable (PCTES2015070236) and later apply for a clinical trial with our injectable in clinical sepsis.

The Spanish Agency of Medicines and Medical Devices (AEMPS) authorized a Phase II clinical trial to evaluate toxicity, safety (as it was the first clinical trial with an intravenous melatonin injectable in patients), and benefits (Eudract: 2008-006782-83, Prevention of MODS by modulating the systemic inflammatory response through melatonin administration in surgical patients with severe sepsis).

The results were very significant, both in reducing mortality and reducing hospital stay for patients, as well as improving inflammatory and oxidative stress indices.

In the midst of this, the SARS-COV-2 pandemic emerged. Upon learning that COVID-19 patients were dying in the ICU due to multiorgan failure, i.e., the same process as in sepsis, we decided to request from AEMPS a Phase II clinical trial with our melatonin injectable in these patients.

Following authorization (EudraCT 2020-001808-42, Phase II clinical trial, single-center, double-blind, randomized, placebo-controlled to explore the efficacy and safety of intravenous melatonin in ICU-admitted COVID-19 patients (MELCOVID study). This study was conducted in 2020, and the very promising results indicated something similar to what happened in sepsis.

Given the current situation, we are considering conducting corresponding Phase III clinical trials for both sepsis and COVID-19. However, since COVID-19 is being controlled through vaccination and there are very few patients in the ICU, whereas sepsis is an endemic disease that continues to have, and even increase, mortality above 25% due, among other factors, to antibiotic resistance, our current priority is to conduct the Phase III trial in sepsis.

Pharmamel’s project was presented at Capital Cell’s Demo Day, and in the following video, you can view the company’s presentation and pitch deck.

Why is Capital Cell investing in this company?

Pharmamel is in a privileged position to achieve an "exit" in a relatively short timeframe. With the work of the international consulting firm Veristat, Pharmamel has already defined the regulatory strategy to obtain the registration of its drug with the EMA and FDA.

The company's strategy is now aimed at going public to finance the rest of the Phase III clinical trials and commercial approval; for this, Pharmamel began the process to list on the BME Scaleup months ago, with the help of the registered advisor Armanext.

During 2025, the company will prepare to scale to markets with higher liquidity, such as BME Growth or Euronext, with the goal of allowing shareholders to make a total or partial exit with high returns in 2026.

The BME ScaleUp listing is scheduled for the last quarter of 2024, with an estimated valuation of 45 million euros.

Minimum investment: 1.000
Drag-along rights
Tag-along rights
Tax deductions
Main risks

Pharmamel's product has successfully passed two Phase II clinical trials, which represents a significant reduction in scientific risks. However, the Phase III clinical phase remains the most demanding and decisive for obtaining final product approval.

The financial challenges of listing on financial markets are not simple, and any IPO entails uncertainty about the future valuation of the company. In any case, the potential for Pharmamel's revaluation is very broad, and we believe this is a minor risk.

More information

Results of sepsis clinical trial: Reduction of mortality by 20% and reduction of hospital stay by 22%.

Pharmamel has initiated the process to go public by the end of 2024 on a Growth or Scale market, teaming up with registered advisor and listing sponsor Armanex, and applying in Euronext and BME's pre-market environment.

Valuation and external consulting: 72% chance of success, current valuation 70 million euros, expected return of 5.89%.

Results of the COVID-19 phase II clinical trial: 25% reduction in hospital stay, 40% reduction in mechanical ventilation time.

Melatonin slows down the exaggerated inflammatory response in sepsis, inhibiting the highly toxic "cytokine storm", and eliminates free radicals, which reduces oxidative damage to organs and tissues.

Melatonin protects mitochondria from damage produced by these radicals, increasing their capacity to generate energy to enhance cellular defense, promote the adaptive immune response, to generate specific antibodies against the agent causing sepsis.

Melatonin slows down the exaggerated inflammatory response in sepsis, inhibiting the highly toxic "cytokine storm", and eliminates free radicals, which reduces oxidative damage to organs and tissues.

Pharmamel and the international regulatory affairs and CRO consultancy Veristat are already developing the first phases of the Phase III clinical trial, to bring the drug to market in approximately 36 months.

Our experts say

A new approach to a major health problem using an innovative melatonin product, meeting a market need for which there are no good enough alternatives.

Beatriz Irene Fernandez

Mayo Clinic Researcher in Cancer Metabolism

Pharmamel's approach, based on years of dedicated scientific research, reflects significant progress in the fight against one of the most challenging conditions in critical care. If these results can be replicated and extended in further studies, this drug could have a considerable impact on clinical practices and patient outcomes in the treatment of sepsis.

Pablo J. Lopez-Soto

GC31 principal investigator and professor at the University of Cordoba.

Sepsis is a global health priority with significant clinical and economic impact. Scientific data show the anti-inflammatory and antioxidant properties of melatonin treatment in sepsis. In addition, early phase clinical trials demonstrate the efficacy of melatonin during sepsis, reducing harm and mortality. Overall, Pharmamel's project potentially constitutes a relevant treatment for sepsis, decreasing morbidity and mortality, and thus impacting the health and economic systems.

Carolina Doerrier Velasco

Senior Scientist

The final rating

APPROVED: This company has successfully passed a rigorous legal and financial analysis.

Approved by
The BioExpert Network is an independent and exclusive network of experts in the life science industry and investment. Only proposals that receive positive evaluations in innovation, science, finance... make it successfully through to the funding campaign stage of Capital Cell.
Team
81%
Science
84%
Innovation
79%
Business
78%
Approved by
Alira Health is an international consultancy that provides a suite of integrated services designed to help companies in the healthcare and life sciences sectors.
Market access
70%
Regulatory
75%
Approved by
Elion is an intellectual property (IP) agency, which helps biotech and medtech start-ups with their protection strategies, patent drafting and prosecution, as well as freedom-to-operate studies.
Intellectual Property
73%

The project

Development of new melatonin-based drugs for sepsis, inflammatory, and viral diseases.

SEPSIS

Sepsis is characterized by an excessive inflammatory response to an infectious agent. A comprehensive analysis of the current state of sepsis worldwide has recently been published (Rudd KE et al. The Lancet 2020; 395:200-211).

The most common cause of death in any country worldwide is multiorgan failure. In 1990, an estimated 60.2 million cases of sepsis and 15.7 million deaths were reported worldwide. This figure decreased somewhat in 2017, with approximately 48.9 million cases and 11 million deaths. In 2020, sepsis cases rose again to around 50 million worldwide, with 12-15 million deaths. One in five deaths globally is associated with sepsis, including a significant number of children in impoverished areas. Moreover, many survivors of sepsis experience significant complications throughout their lives.

While most cases occur in low or middle-income countries, sepsis remains the leading cause of death in hospitals worldwide. In the USA alone, its cost is estimated at over $62 billion annually, a figure similar to the EU.

There are currently no specific treatments that can control the inflammatory response and multiorgan failure, hence the persistently high mortality. The WHO urges all countries to identify, prevent, and treat sepsis.

The primary treatment for sepsis involves antibiotics to curb the infection and fluid therapy to restore blood pressure. However, these measures are insufficient to reduce this pathology, as mentioned above.

The WHO considers it a high priority to find a treatment for sepsis. Clinical trials are currently underway to find an effective drug against sepsis but with no positive results. The problem is that there is no drug that, in addition to being effective, does not have significant side effects. This situation arises because sepsis is a very complex response that includes, in addition to an exaggerated activation of the innate immune response, a state of oxidative stress due to excessive production of free radicals that damage all tissues. These free radicals cause mitochondrial dysfunction, which, along with the cytokine storm resulting from inflammation, leads to multiorgan failure and patient death.

In other words, an effective drug against sepsis must meet the following criteria:

  1. Inhibit the innate immune response, in its two main pathways activated in sepsis: the NF-κB pathway and the NLRP3 inflammasome pathway. While there are drugs that inhibit the first pathway (such as corticosteroids), none exist for the second pathway, which we described as responsible for the severity of sepsis.

  2. Suppress the production of free radicals during sepsis.

  3. Activate mitochondrial function and ATP production, the cell’s energy currency.

Melatonin fully and highly effectively fulfills these three functions.

THE SOLUTION: MELATONIN INJECTABLE

After discovering extraspinal melatonin, we analyzed its properties in the cell, concluding that it possesses highly effective anti-inflammatory, antioxidant, and mitochondrial protective properties. For these reasons, we decided to use melatonin against sepsis. To do so, we conducted extensive animal experimentation in sepsis models in rats and mice, including sepsis induced by the administration of bacterial lipopolysaccharides and sepsis induced by cecal puncture (more similar to human sepsis). Once the high efficacy of melatonin administered by intraperitoneal or subcutaneous injection in these animals was demonstrated, as well as the absence of negative side effects at the hepatic, renal, cardiovascular, and metabolic levels, we requested a clinical trial from the Spanish Agency of Medicines and Medical Devices (AEMPS) to use melatonin in clinical sepsis.

The AEMPS indicated that to administer melatonin intravenously (IV) in sepsis patients (as oral administration is not useful in ICU patients due to intestinal absorption problems), and given that there was no melatonin injectable available on the market, we had to first present the appropriate formulation to them. This led us to formulate and patent a melatonin injectable for human (and veterinary) use, against inflammatory processes but also pathologies associated with increased free radicals and mitochondrial dysfunction.

The melatonin injectable is patented (ES2392903B1, PCT/ES2015/070236) as a long-term stable melatonin preparation to curb inflammatory processes and, specifically, for sepsis.

This intravenous formulation allows excellent bioavailability of the product, quickly reaching therapeutic levels in the blood.

Furthermore, melatonin has very little or no toxicity, and the excipients used in the formulation are widely used in pharmaceutical human injectable products.

Results from the Phase II Clinical Trial in Spain: Prevention of MODS by modulating the systemic inflammatory response through melatonin administration in surgical patients with severe sepsis, EudraCT No: 2008-006782-83.

(VIDEO)

Melatonin intravenous injectable (patent ES2392903B1, PCT/ES2015/070236, owned by Pharmamel), is currently extended to the following countries:

HE Ref.:

COUNTRY

APPLICATION Nº

FILING DATE

LEGAL STATUS

NEXT DEADLINES

901 673

US

15/129,327

27/3/15

Under Examination

901 674

EP (EUROPE)

15 769 253.4

27/3/15

Under Examination

31.03.2022 – Annuity

901 703

BR (BRAZIL)

BR1120160223942

27/3/15

Under Examination

27.06.2022 – Annuity

906 773

CN (CHINA) Divisional

2021115548860

27/3/15

Under Examination

The drug has been tested in a Phase II clinical trial authorized by the AEMPS to evaluate its toxicity and efficacy.

This is the first clinical trial with intravenous melatonin in patients with sepsis. The patients in the clinical trial presented severe sepsis requiring abdominal surgery.

This was a double-blind trial, with 14 patients placebo and 15 with IV melatonin administered at a dose of 60 mg/day for 5 days. Patients were followed until hospital discharge.

Treatment:

Melatonin: solution in ampoules of 6 mg melatonin/mL, total 10 mL = 60 mg. One ampoule (60 mg) per day for 5 days.

Placebo = same excipient as melatonin injectable, and same volume injected.

Main results:

  1. Hospital stay has been reduced by 20% in patients treated with melatonin versus placebo.
  2. Mortality in the melatonin group was reduced in the placebo group (40%). SOFA, a scale indicating the evolution of the patient with sepsis, was reduced in the group treated with melatonin versus placebo, indicating a better evolution of the former.
  3. Oxidative stress and oxidative damage were lower in the melatonin-treated group than in the placebo.
  4. Immune system activity showed a reduction of neutrophils and an increase of lymphocytes, providing a much lower NLR (neutrophil/lymphocyte ratio) in the melatonin group than in the placebo, demonstrating a positive evolution of septic patients treated with melatonin.
  5. Other markers of inflammation such as procalcitonin also showed a significant reduction in the melatonin group, another indication of inflammatory improvement in these patients compared to placebo.
  6. The results also indicate a complete absence of hepatic, cardiovascular, renal, and metabolic toxicity.

This injectable formulation has many other applications to control inflammation in cardiovascular pathologies, stroke, post-surgical recovery, premature babies, viral and bacterial infections, etc.

(VIDEO)

(PPT ENSAYO CLINICO- RESULTADOS)

COVID 19

In the face of a pandemic such as the one we face today from COVID-19, the questions of how to combat these threats and how to reduce the lethality of infected persons are crucial. Solutions are especially urgent when specific therapies are not available. Vaccination is very important but new variants are emerging. Even for long-known coronaviruses, their genetic variability leads to several subtypes that differ in appearance from year to year, such as seasonal influenza, which requires repeated adaptations of vaccines.

VIDEO

VIDEO

The alternative to vaccines requires the identification of a drug that controls the virus. This requires that the potential antiviral drug interferes with intracellular processes such as binding to host cell proteases, interference with the fusion of the viral envelope with host cell membranes, virus replication, or virion release. In the case of SARS-COV2, so far, there are major limitations in identifying antiviral drugs that control the virus.

The antimalarial drug chloroquine, which was used in COVID-19, had numerous side effects and was therefore discontinued. Also requiring further investigation is chemostat mesylate, an inhibitor of the host cell surface protease required for endocytic entry of SARS-CoV-2 virus after attachment, but which has not provided significant results. Aplidin (plitidepsin) has been used in a patient efficacy trial of COVID-19 and published results speak of good efficacy in vitro but not in patients. Currently, a Pfizer drug, Paxlovid, is being marketed in both the USA and the EU and appears to have some efficacy against SARS-COV-2, although testing is required in the next few years.

In a recent publication on antiviral drug repurposing, and by quantifying the interaction between the HCoV-host interactome and drug targets in the human protein-protein interaction network, melatonin has been identified as a potential anti-HCoV drug (Network-based drug repurposing for novel coronavirus 2019-nCoV/SARS-CoV-2).

The analysis of melatonin as a potential drug in the COVID-19 pandemic should be done from the perspective of controlling host responses to viral infection, especially concerning severe disease progression as these inflammatory responses are often lethal. It should be noted that the high mortality of viral infectious diseases such as COVID-19, SARS, Ebola, MERS, or avian influenza is caused by an uncontrolled innate immune response with destructive inflammation.

CURRENT SITUATION

The underlying mechanisms for the high lethality of such viral infections involve free radical attack and destructive inflammation in numerous tissues and organs. Just as in Ebola, the primary effector is the vascular system, in the case of COVID-19, it is the lung. While the responses are linked to host innate immune system damage, in several cases, a direct viral contribution to inflammation has become evident. For example, the SARS-CoV viroprotein ORF3a has been shown to activate the NLRP3 inflammasome through ubiquitination.

As agents that prevent NLRP3 activation are known, anti-inflammatory treatments are promising. However, the use of anti-inflammatory drugs with immunosuppressive properties such as glucocorticoids and non-steroidal anti-inflammatory drugs (NSAIDs) is not recommended for the combat of an infectious disease. It is thus highly desirable to identify molecules that combine anti-inflammatory effects with immunostimulatory actions, especially of the adaptive immune response. One agent that possesses these dual properties is melatonin.

In COVID-19 infection, free radical formation and massive inflammatory reactions are associated with the release of large numbers of cytokines («cytokine storm»). Pathogens per se serve as PAMPs (pathogen-associated molecular patterns), molecular patterns that trigger a primary «cytokine storm» while damaged host cell molecules function as DAMPs (dangerous associated molecular patterns), molecular patterns responsible for a secondary «cytokine storm». This becomes a vicious cycle and, if not interrupted, leads to massive tissue and organ damage and possible death.

Most of the aforementioned viral diseases are self-limited by an adaptive immune response that depends on cell proliferation and therefore requires several weeks to develop. In this window period, patients are vulnerable and mortality is high. Controlling the innate immune response and reducing inflammation during this period increases patient tolerance and decreases mortality in virus infection.

Melatonin is a powerful free radical scavenger to reduce oxidative tissue damage, and it is also an effective anti-inflammatory agent to depress the «cytokine storm». As a result, melatonin can increase host tolerance to pathogens and save precious time for patients to develop an adaptive immune response and ultimately recover from pathogen attacks. In addition, melatonin also promotes the adaptive immune response by increasing the proliferation of T lymphocytes and B cells to generate specific antibodies. Numerous studies have demonstrated the beneficial effects of melatonin on fatal viral infections in different animal models, and its therapeutic efficacy in patients with septic shock.

In the process of cell infection by the Sars Cov2Sa virus, cathepsins, which are proteins with proteolytic activity, play a very important role, in addition to inflammatory and prooxidant processes. These proteases are essential for the entry of the virus into the cell, the virus binds to its ACE2 receptor and, through the activation of cathepsins, facilitates the formation of the endosome and its entry into the cell.
Melatonin has been shown to inhibit cathepsins by inhibiting virus proliferation.

VIDEO.

Therefore, due to the numerous existing studies on the properties of melatonin, a study of its effectiveness against the envelope and nucleocapsid proteins of 2019-nCoV/SARS-CoV-2 has been performed. Using proximity analysis, Zhou et al. have prioritized several potential molecules against the virus, including melatonin.

Results: Phase II, single-center, double-blind, randomized, placebo-controlled clinical trial to explore the efficacy and safety of i.v. melatonin in patients with COVID-19 admitted to the ICU (melcovid study) EudraCT 2020-001808-42.

The same intravenous melatonin injectable (patent ES2392903B1, PCT/ES2015/070236, owned by Pharmamel), as used in the sepsis clinical trial, has been used. The anti-inflammatory and antioxidant effects of melatonin are exerted at high doses of melatonin. The doses have been selected according to numerous experiments in animal models of sepsis and mucositis, in our Research Group, which allowed us to calculate the human equivalent dose, ranging from 50 to 500 mg/day for use in covid-19.

These high doses of melatonin in patients have already been tested in two clinical trials of two different formulations: one, the Phase II clinical trial (EudraCT: 2008-006782- 83) in patients with sepsis already indicated, at the dose of 60 mg IV/day for 5 days, with very important results, and another Phase II clinical trial (EudraCT: 2015-001534-13) with an oral melatonin gel, at the dose of 1.5 grams/day during treatment (2-3 weeks), against mucositis in patients with head and neck cancer treated with chemo and/or radiotherapy, also with excellent results. In no case were hepatic, renal, cardiovascular, metabolic, or any other type of side effects observed. Numerous studies support the safety and absence of side effects of melatonin at high doses.

In light of the above and given the health situation the world is going through, we have scientific and clinical evidence that intravenous melatonin injectables are useful for treating patients infected with COVID-19.

Solutions to this situation are especially urgent when no specific therapies are available. Vaccination is important, but treatment is essential because, despite vaccination, people continue to be infected with the added value that new variants are appearing that may be more contagious than the previous ones. Therefore, the pandemic will end when treatment is available. So far, there are no effective treatments, although a wide range of molecules are being tested. For this reason, the Spanish Agency for Medicines and Health Products authorized us to carry out a Phase II clinical trial in patients with COVID-19.

This is the first clinical trial with intravenous melatonin in patients with Covid-19. It was conducted in patients with COVID-19 admitted to the ICU, This was a double-blind trial, with 6 patients treated with a placebo and 12 with IV melatonin at the dose of 5 mg/kg/day/4 times daily/ for 7 days. Patients were followed until hospital discharge.

Treatment:

Melatonin: solution in ampoules of 6 mg melatonin/mL, total 10 mL = 60 mg. Dose of 5 mg/kg/day for 7 days, with a maximum of 500 mg/day/7 days.

Placebo = same excipient as melatonin injectable and same volume injected.

Main results:

  1. Reduction of hospital stay by 25% in patients treated with melatonin vs. placebo.
  2. Reduction of mechanical ventilation time by 40% in patients treated with melatonin vs. placebo.
  3. Reduction of invasive mechanical ventilation by 23% in patients treated with melatonin vs. placebo.
  4. It increased non-invasive mechanical ventilation time by 55% in patients treated with melatonin vs. placebo.
  5. Reduction of acute inflammation markers (ferritin, D-dimer, IL-6) in patients treated with melatonin vs. placebo.
  6. Increase of lymphocytes and reduction of neutrophils in patients treated with melatonin versus placebo.
  7. The results indicate an inflammatory improvement in patients treated with melatonin, as they show a reduction in proinflammatory cytokines and humoral immunity, and an improvement in cellular immunity compared to the placebo group.
  8. In addition, there have been no signs of toxicity or adverse effects.

(RESULTADOS ENSAYO CLINICO)

Bibliography and scientific references.

  • Rudd et al. The Lancet 2020; 395: 200–211. doi: 10.1016/S0140-6736(19)32989-7: 10.1016/S0140-6736(19)32989-7.
  • García et al. Faseb J. 2015; doi: 10.1096/fj.15-273656.
  • World Health Statistics, World Health Organization, 2018.
  • Gao et al. BioSci. Trends 2020;4:72-73. DOI: 10. 5582/bst.2020.01047.
  • Hoffmann  et al. Cell 2020; DOI: 10.1016/j.cell.2020.02,052.
  • Zhou Cell Discovery. 2020:DOI.org/10.1038/s41421-020-0153-3 et al.
  • Tan DX, Hardeland R (2020). The potential utility of melatonin in deadly infectious diseases related to the overreaction of innate immune response and destructive inflammation: focus on COVID-19. Melatonin Research. 3, 120-143. DOI.org/10.32794/mr11250052.
  • Hen IY, et al. (2019) Severe acute respiratory syndrome coronavirus viroporin 3a activates the NLRP3 inflammasome. Front. Microbiol. 10: 50.
  • Venegas C, García JA, Escames G, Ortiz F, López A, Doerrier C, García-Corzo L, López LC, Reiter RJ, Acuña-Castroviejo D (2012) Extrapineal melatonin: analysis of its subcellular distribution and daily fluctuations. J Pineal Res; doi:10.1111/j.1600-079X.2011.00931.
  • Hou Y., Hou Y, Shen J, Huan Y, Martin W, Feixiong Cheng F (2020). Network- based drug repurposing for novel coronavirus 2019-nCoV/SARS-Co. Cell Discovery. DOI.org/10.1038/s41421-020-0153-3.

 

Our team

Pharmamel is working on a significant project that is being led by a team of entrepreneurial and multidisciplinary professionals. These experts possess diverse skills and a proven track record of success in managing various areas of the company. Pharmamel has also partnered with multiple collaborators, institutions, and technological partners who provide essential support to help realize the project.

Management team

Darío Acuña Castroviejo , Ph.D.- Scientific Director and co-founder
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Darío Acuña Castroviejo is a Professor of Physiology at the University of Granada and a Medical Specialist in Clinical Analysis at the San Cecilio University Hospital in Granada. He is a member of the research group CTS-101: Intercellular Communication, CIBERfes, CIBER on Aging and Fragility of ISCIII, and Ibs. Granada, all directed by Professor Germaine Escames. The primary focus of his scientific activity is melatonin and mitochondria, with over 250 scientific publications. In collaboration with Professor Escames, some of these results have led to the patenting of new melatonin formulations for clinical applications, including sepsis, COVID-19, cancer, and mucositis, for which they conducted clinical trials with a melatonin injectable and a melatonin cream for topical application to regenerate the skin.

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Germaine Escames , Ph.D. - Scientific Director and co-founder
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Germaine Escames is a Professor of Physiology at the University of Granada.

She is a specialist in Clinical Biochemistry and director of the Research Group CTS-101: Intercellular Communication, of the CIBER of aging and frailty of the ISCIII and the Ibs.Granada. She is also co-director of the International Melatonin Institute (IiMEL) and co-founder of the company Pharmamel.

She has developed her research during the last 30 years by studying the properties and mechanisms of action of melatonin and its function in the mitochondria. She is a world leader, together with Prof. Acuña, in the field of melatonin. He has published more than 250 papers and received numerous awards. He has collaborated with numerous scientists, such as Prof. Reiter from the Health Science Center of San Antonio in Texas (USA) and Prof. Cardinali from the University of Buenos Aires (Argentina) among others. The result of all his research has been numerous patents for the treatment of different pathologies such as sepsis, mucositis, cancer, and skin treatment. In turn, together with Professor Acuña, he has launched two clinical trials with melatonin injectable, one in sepsis and the other in COVID-19.

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Ramón García , CEO and co-founder
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Ramón García is a serial entrepreneur with extensive experience in the creation and leadership of start-ups, as well as in technology transfer and business innovation.

Before joining Pharmamel, he was a key player in the success of several start-ups, where he held management roles and provided his experience and expertise in technology transfer and business strategy. In addition, he has worked as a consultant to several established companies, helping them to improve their processes and optimize their performance.

He has been recognized for his ability to identify business opportunities and design effective strategies to carry out innovative projects, with the University of Granada University Entrepreneurship Award, Granada City of Science and Innovation, and Aje Entrepreneurship Award.

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Juan Miguel Piernas , CFO co-founder
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Juan Miguel Piernas is an economist with extensive experience in finance and business leadership.

Before joining Pharmamel, Juan Miguel Piernas held management positions in several companies in different sectors, such as telecommunications, consulting, and the financial sector.

He has a solid academic background in finance and business economics, which has allowed him to develop his career in different areas of business management. He is also an expert in data analysis and financial decision-making.

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Jordi Roma , Director of operations and clinical management
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Specialist in Internal Medicine graduated from the UAB in 1979. Graduate in Health Sciences Statistics from the same university.

In 1992 I joined the Pharmaceutical Industry in the medical department of Prodesfarma S.A., being the medical director until 1998. The development of Aceclofenac achieved its approval by the Spanish Ministry of Health, and the drug agencies in the UK, and finally it is the first Spanish active ingredient that obtained approval from the European Medicines Agency.

No less important was the creation of the first Pharmacovigilance department and the activity in the incipient ICHA3 (Single case report). Until the end of 2003, I directed a pharmaceutical research unit at the Centre Hospitalari de Manresa, actively participating in more than 100 clinical trials, from phase I to phase III, including bioequivalence of various products. With a preferential agreement with Simbec International UK. During these years I was an active member of the Clinical Trials Ethics Committee.

In recent years I have developed my professional activity between the world of production and research of pharmaceutical products, mostly in the world of new generics and second chances of known drugs.

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Antonio Bayo. , Assistant to management.
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Chartered economist and experienced insolvency administrator with an outstanding career of more than 30 years in the financial and business field. With an exceptional ability to lead financial restructuring processes, he has played key roles in the management of several companies, contributing to the success and stability of organizations both nationally and internationally. With cumulative successes in improving the financial health of several companies, resulting in a significant increase in investor confidence. Antonio Bayo's extensive experience, backed by his remarkable achievements and skills in financial management and insolvency administration, positions him as a highly skilled professional committed to Pharmamel's business success.

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Advisors

Daniel Cardinali
Ph.D. - External Scientific Advisor
Russel Reiter
Ph.D. - External Scientific Advisor

The problem

Sepsis is a pathology characterized by an exaggerated inflammatory response to an infectious agent. Over 50 million cases are diagnosed each year, resulting in 25% of deaths.

It is the leading cause of death in the Intensive Care Unit (ICU) of any hospital worldwide. Sepsis is characterized by activation of proinflammatory cytokines (cytokine storm), increased exaggerated oxidative stress, and mitochondrial damage, leading to multiorgan failure and patient death. There is currently no treatment for sepsis, and the World Health Organization (WHO) urges all countries to take prompt action.

The solution

Following the experimental results obtained, we patented an injectable formulation of intravenous melatonin, based on:

  1. High concentrations of intravenous melatonin, stable at room temperature.
  2. Sepsis models confirmed the mode of action, low toxicity, reduced inflammation, and animal survival.
  3. Clinical studies demonstrate the high effectiveness of melatonin in controlling inflammation associated with sepsis, as well as a decrease in mortality and hospital stay.

Our differentiation

Currently, there are no specific treatments for sepsis to control the exaggerated inflammatory response and multiorgan failure, leading to a persistently high mortality rate.

The primary treatment for sepsis involves antibiotics to address the infection and fluid therapy to restore blood pressure and prevent multiorgan failure. However, these measures are not sufficient to curb this epidemic and prevent high mortality rates, which are further exacerbated by antibiotic resistance. Our melatonin injectable emerges as the only viable alternative to address this global issue.