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-stage
biotechnology 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-2 virus
and its effects, by launching a new clinical development program: COVA, with
Sarconeos (BIO101) as a potential treatment for respiratory failure associated
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-19 has
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-angiotensin system, the very one which is attacked by the
SARS-Cov-2 virus. 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."
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.
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
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.
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.
Biophytis Contact for Investor
Relations Evelyne Nguyen, CFO