Biophytis : Launches COVA Clinical Study with Sarconeos (BIO101) in Covid-19. Read the Press Release

Press release

Biophytis Launches COVA Clinical Study with Sarconeos

(BIO101) in Covid-19

Paris, (France), Cambridge (Massachusetts, United States), April 7th, 2020, 8:00 a.m. CEST - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stagebiotechnology company specialized in the development of drug candidates for treatment of aged related diseases, amongst which neuromuscular diseases, today announces that it is joining the global effort to fight the SARS-CoV-2virus and its effects, by launching a new clinical development program: COVA, with Sarconeos (BIO101) as a potential treatment for respiratory failure associated with Covid-19.

The COVA clinical program consists of evaluating the therapeutic efficacy and the safety of Sarconeos (BIO101) in the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. The Phase 2/3 clinical trials are expected to start in the coming weeks in France, following approval from the French National Agency for the Safety of Medicines (ANSM- Agence Nationale de Sécurité du Médicament), and should then extend to Belgium and the United States. The first randomized patient is expected to be recruited at the Pitié-Salpêtrière Hospital, which is linked with Sorbonne University's medical school, a long-standing partner of Biophytis.

Sarconeos (BIO101) is a drug candidate that has demonstrated an excellent safety profile during the SARA development program which is evaluating its ability to improve muscle function in frail elderly patients with sarcopenia (the phase 2b study, SARA-INT, is currently underway). Sarconeos (BIO101) is also being developed to improve the respiratory function of children with Duchenne muscular dystrophy (DMD), Biophytis' MYODA DMD program is expected to start in H2 2020.

The COVA program builds on the clinical and preclinical data generated with Sarconeos (BIO101) in these neuromuscular diseases.

Stanislas Veillet, President and CEO of Biophytis, said: "Covid-19has completely transformed our society on a global scale, and has had a devastating effect particularly on the frail elderly. We are very eager to answer the calls from our industry and national and international organizations to join the global effort to fight this pandemic. Sarconeos (BIO101) has been shown to restore normal respiratory function in several experimental models by activating the renin-angiotensinsystem, the very one which is attacked by the SARS-Cov-2virus. In the absence of a suitable vaccine or a proven antiviral therapy we believe that Sarconeos (BIO101) could offer an important potential treatment option for patients with acute respiratory failure associated with COVID-19,potentially limiting the need for ventilators and speeding up their potential recovery. We anticipate an approval from the ANSM (and potentially other regulatory bodies) to enable us to start our COVA program, allowing us to respond as quickly as possible to this health emergency."

Press release

The Coronavirus SARS-CoV-2 can cause ARDS by disrupting the renin angiotensin system (RAS), which has a key role in regulating respiratory function. It is believed that SARS-CoV-2 enters the lung cells using the Angiotensin 2 Converting Enzyme (ACE-2), a key enzyme in the RAS, inhibiting the system's protective arm. Sarconeos (BIO101) activates the MAS receptor, a key component of the protective arm of the RAS, and has been shown to restore respiratory function in several preclinical models.

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About BIOPHYTIS

Biophytis SA is a clinical-stage biotechnology company specialized in the development of drug candidates to slow down degenerative processes and improve functional abilities in patients with age-related diseases, especially neuromuscular diseases.

Sarconeos (BIO101), our leading drug candidate, is a small molecule, administered orally, currently in clinical Phase 2b in sarcopenia (SARA-INT) in the United States and Europe. A pediatric formulation of BIO101 is being developed for the treatment of Duchenne Muscular Dystrophy (DMD). The company plans to start the clinical development in H2 2020.

Sarconeos (BIO101) will also be developed as a treatment for Covid-19 (Coronavirus) for which the company has filed a clinical trial application with the French Regulatory Authority (ANSM).

The company is based in Paris, France, and Cambridge, Massachusetts. The company's common shares are listed on the Euronext Growth Paris market (Ticker: ALBPS -ISIN: FR0012816825). For more information www.biophytis.com.

Disclaimer

This press release contains forward-looking statements. While the Company considers its projections to be based on reasonable assumptions, these forward-looking statements may be called into question by a number of hazards and uncertainties, so that actual results may differ materially from those anticipated in such forward-looking statements. For a description of the risks and uncertainties likely to affect the results, BIOPHYTIS' financial position, performance or achievements and thus cause a change from the forward-looking statements, please refer to the "Risk Factors" section of the Company's 2018 Annual Report available on BIOPHYTIS website ( www.biophytis.com).

This press release, and the information contained in it, does not constitute an offer to sell or subscribe, nor the solicitation of a purchase or subscription order, of BIOPHYTIS shares in any country. The elements contained in this communication may contain forward-looking information involving risks and uncertainties. The Company's actual achievements may differ materially from those anticipated in this information due to different risk and uncertainty factors. This press release was written in French and English; If there is a difference between the texts, the French version will prevail.

Press release

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