Biophytis, a clinical-stage biotechnology company dedicated to developing therapeutics that fight the effects of aging and improve functional outcomes for patients suffering from age-related diseases, announced that it has filed for a meeting with the FDA to discuss the possibility of Emergency Use Authorization (EUA) for Sarconeos (BIO101) to treat severe forms of COVID-19 in the United States. By providing a potential therapeutic solution for those suffering from the disease, this filing is providing a much-needed ray of hope.
Sarconeos (BIO101) is taking a major step forward in fast-tracking market access in the United States to treat severe forms of COVID-19. This follows a successful similar process initiated with the European Medicine Agency (EMA) back in May, during a time when the virus continues to be a public health burden both in the US and EU. This is an important milestone towards delivering this effective treatment as soon as possible, especially in a complex global health crisis.
Stanislas Veillet, Chief Executive Officer of Biophytis, is actively steering towards the completion of a roadmap to bring the drug candidate Sarconeos (BIO101) to suffering Americans with severe forms of COVID-19.
The COVA study of the drug has yielded positive clinical results with a 44% reduction in the risk of respiratory failure or early death, lending promising support to the potential of the drug to become a new, viable therapeutic option alongside antiviral and anti-inflammatory treatments.
With the WHO highlighting the great continued medical need to tackle the thousands of weekly deaths in the US and Europe, Biophytis is in talks with the FDA to possibly file an Emergency Use Application by the end of 2023 or by the first half of 2024.
About BIOPHYTIS
Biophytis SA is a groundbreaking biotechnology company at the clinical-stage, developing innovative drug candidates to effectively combat age-related diseases. Our major drug candidate, Sarconeos (BIO101), is a small molecule with the capacity to address neuromuscular and cardiorespiratory problems – including Duchenne Muscular Dystrophy and, most recently, severe Covid-19.
Following positive clinical results in global phase 2 and 3 studies, Sarconeos is on track for Conditional Marketing Authorization (CMA) applications in Europe and Emergency Use Authorization (EUA) applications in the United States.
The company has also developed a pediatric formulation of the drug to treat Duchenne Muscular Dystrophy. Headquartered in Paris, France, and Cambridge, Massachusetts, shares are listed on both Euronext Growth (Ticker: ALBPS – ISIN: FR0012816825) and the Nasdaq Capital Market.