Biophytis - First US Patient Enrolled in COVA, a Multinational Phase 2/3
Clinical Trial with Sarconeos (BIO101) for the Treatment of COVID-19 Related
First Patient Dosed at Natchitoches Regional Medical Center in Louisiana - US
Total of seven centers open for patient recruitment in Europe and the Americas
Paris, (France), Cambridge (Massachusetts, United States), October 13, 2020,
7:00 p.m. CEST - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage
biotechnology company specialized in the development of drug candidates for
treatment of age-related diseases, including neuromuscular diseases, today
announces that the first US patient has been enrolled in the COVA study at
Natchitoches Regional Medical Center, Barnum Medical Research, in Louisiana
Biophytis holds an Investigational New Drug (IND) application from the FDA to
start COVA, a multinational Phase 2/3 Clinical Trial with Sarconeos (BIO101)
for the treatment of patients with COVID-19-related respiratory failure, in the
The trial has been making good progress with now seven centers open and ready
to recruit COVID-19 patients in Belgium, France, Brazil and in the US.
Dr Otis Barnum, MD, internist in Natchitoches, Louisiana and Principal
Investigator Coordinator of COVA in US, said: "Finding an effective therapeutic
agent to treat patients who became severely ill due to COVID-19 is vital if we
are going to reduce the mortality rate and hospitalization from this pandemic.
The objective of this study is to investigate whether BIO101 can prevent
further respiratory deterioration, reduce mortality and the duration of
hospitalization in these patients."
The COVA clinical study (clinicaltrials.gov identifier NCT04472728) is a Phase
2/3, randomized, double-blind, placebo-controlled, adaptive and group
sequential study assessing Sarconeos (BIO101) in patients aged 55 and older,
infected with SARS-CoV-2. It is designed to evaluate the efficacy and the
safety of Sarconeos (BIO101) as a treatment to prevent further deterioration in
patients with COVID-19-related respiratory failure. The objective is to prevent
them from being admitted to the intensive care unit (ICU) and requiring
This pivotal multinational clinical trial will be conducted in two parts, the
first of which will assess the treatment safety and provide an indication of
activity of Sarconeos (BIO101) in 50 hospitalized COVID-19 patients suffering
from acute respiratory deficiency.
The second part of the study will investigate the efficacy of Sarconeos
(BIO101) on the respiratory function of an additional 260 COVID-19 patients.
The primary endpoint of the COVA study is the proportion of all-cause mortality
and respiratory deterioration within up to a 28-day period.
Secondary endpoints include records of improvement, worsening and hospital
discharge, functional scales and the biomarkers associated with the mechanism
of action of Sarconeos (BIO101) and inflammation.
Stanislas Veillet, CEO of Biophytis says: "At Biophytis we are working hard to
rapidly recruit the patients needed, to help determine whether Sarconeos
(BIO101) has the potential to play a role in addressing the COVID-19 global
pandemic. The COVA trial will provide important clinical data to determine the
potential benefit that Sarconeos (BIO101) can deliver via its activity on the
renin angiotensin system (RAS), which plays a key role in regulating
We project enrollment of the 50 patients required for the first part of the
study to complete before the end of the year, provided the opening of 20
centers in the study. The results of the COVA trial are expected before the end
of 2021, depending on the evolution of the pandemic."
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, including
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 Sarconeos (BIO101) is
being developed for the treatment of Duchenne Muscular Dystrophy (DMD). The
company plans to start the clinical development (MYODA) in H2 2020.
Sarconeos (BIO101) is also being developed as a treatment for patients with
COVID-19 related respiratory failure in a Phase 2/3 clinical study (COVA) in
the United States, Europe and Latin America.
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 visit 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 Half
Year 2020 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