Pharmamel

Pharmamel S.L. is a clinical-stage biotechnology firm that originated in 2014 as a spin-off from the University of Granada and the Andalusian Health Service. The company is built upon three decades of foundational research into melatonin's role in cellular aging and its antioxidant and anti-inflammatory properties. This extensive scientific journey was led by Professors Darío Acuña-Castroviejo and Germaine Escames, both world-renowned authorities in melatonin research and co-founders of Pharmamel. Their work, which includes over 250 scientific publications, has deeply explored melatonin's mechanisms of action and its protective effects on mitochondria.

The company's primary focus is the development and commercialization of an intravenous melatonin drug candidate to treat sepsis, a life-threatening condition caused by the body's dysregulated response to infection and a leading cause of hospital mortality worldwide. Sepsis affects over 50 million people globally each year, with mortality rates between 25% and 30%, and currently lacks a specific approved drug treatment. Pharmamel's drug aims to address this critical unmet need by targeting the severe inflammation, oxidative stress, and mitochondrial damage that characterize the disease. The technology is licensed from the University of Granada and the Andalusian Health Service, who hold the patent.

Pharmamel's business model centers on advancing its lead drug candidate through clinical trials to ultimate commercialization and licensing to the pharmaceutical industry. After successfully completing two Phase II clinical trials that demonstrated the drug's safety and efficacy in reducing mortality and hospital stays for sepsis patients, the company is now preparing for a pivotal Phase III trial. This final stage is crucial for obtaining market authorization from regulatory bodies like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). To finance this expensive, late-stage development, Pharmamel is pursuing a public listing on the BME Scaleup market, anticipated for late 2024, following a series of pre-IPO funding rounds. The company's strategy involves leveraging these funds to complete the trial and bring the drug to market within approximately 30-36 months.

Keywords: melatonin, sepsis treatment, biotechnology, clinical trials, drug development, University of Granada spin-off, anti-inflammatory, antioxidant, mitochondrial damage, intravenous drug, Darío Acuña-Castroviejo, Germaine Escames, critical care medicine, pharmaceutical licensing, BME Scaleup, drug discovery, organ dysfunction, oxidative stress, clinical-stage, biopharmaceutical