BIOPHYTIS (EPA:ALBPS) - Biophytis –Upcoming Potential Value Generating Milestones

Transparency directive : regulatory news

03/12/2020 08:00

Press Release

          Biophytis -Upcoming Potential Value Generating Milestones

o COVA - Patient recruitment ramping up for this two-part Phase 2/3 study
  assessing Sarconeos (BIO101) for the treatment of severe respiratory
  manifestation of COVID-19

* Completion of trial enrollment (Part 1) anticipated by end of December 2020

* Interim Analysis and completion of trial enrollment (Part 2) expected in Q1
  2021

* Topline results of the full study expected in Q2 2021

* Positive COVA results should allow filing for Emergency Use Authorizations
  (EUA) with the FDA in the US & conditional marketing authorization with the
  European Medicines Agency (EMA) in Europe for Sarconeos (BIO101)

o SARA-INT - Phase 2 study for the treatment of sarcopenia on track.
  Last-patient last visit planned end of December 2020. Topline trial results
  expected in H1 2021

o MYODA - Start of Phase 1 study for the treatment of Duchenne Muscular
  Dystrophy (DMD) expected in H1 2021, depending on the COVID-19 pandemic
  evolution

Paris (France), Cambridge (Massachusetts, U.S.), December 3, 2020, 8:00 a.m.
CET - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage
biotechnology company focused on the development of therapeutics that slow the
degenerative processes associated with aging and improve functional outcomes
for patients suffering from age-related diseases, including severe respiratory
failure in patients suffering from COVID-19, today provides an update on its
clinical developments and an outlook for the coming year.

Stanislas Veillet, Chief Executive Officer, stated: "Older patients or patients
with co-morbidities are expected to continue to be at high risk of developing
severe respiratory manifestations requiring hospitalization, particularly in
light of the recent acceleration of coronavirus cases in both Europe and the
Americas. We now expect to complete enrollment of Part 1 of the COVA trial in
the coming weeks and Part 2 in Q1 2021. Topline results of the full study are
projected for Q2 2021.

If the COVA trial is successful, we expect to submit Sarconeos (BIO101) for
Emergency Use Authorization (EUA) with the US FDA and conditional marketing
authorization with the European Medicines Agency (EMA).

We are on track with our SARA-INT trial and expect that our last patient will
exit the study in the coming weeks. This would allow us to report the first
results from the Phase 2 trial in H1 2021 and start planning for a potential
Phase 3 trial."

Clinical development update:

COVA- Phase 2/3 COVA study for acute respiratory failure associated with
COVID-19

The COVA clinical program (clinicaltrials.gov identifier NCT04472728) is a
global, multicentric, double-blind, placebo-controlled, group-sequential and
adaptive two-part Phase 2-3 study assessing Sarconeos (BIO101) in patients aged
45 and older, infected with SARS-CoV-2.

This pivotal multinational clinical trial is being 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 patients. The study is
designed to evaluate the efficacy and the safety of Sarconeos (BIO101) as a
treatment to prevent further deterioration of patients with COVID-19-related
respiratory failure, which could otherwise require admission to the intensive
care units and ventilation.

The first part of the study is a Phase 2 exploratory proof of concept study to
provide preliminary data on the activity, safety and tolerability of Sarconeos
(BIO101) in 50 hospitalized patients with severe respiratory manifestations
related to COVID-19. Patient recruitment is accelerating in 15 sites in
Belgium, France, Brazil and the US. Our objective is to activate around 30
sites in the study before the end of the year. Biophytis expects enrolment of
Part 1 of the study to be completed in the coming weeks.

The second part of the study will investigate the safety and efficacy of
Sarconeos (BIO101) on the respiratory function of 310 COVID-19 patients
(including the 50 patients from Part 1 of the study).

Topline results from the full study (Part 1 and Part 2) are expected in Q2
2021.

Following positive data and the analysis and recommendation of an independent
Data Monitoring Committee (DMC) Biophytis expects to submit Sarconeos (BIO101)
for Emergency Use Authorization (EUA) with the US Food and Drug Administration
(FDA) and for conditional marketing authorization with the European Medicines
Agency (EMA) in Q2 2021.

SARA clinical program in sarcopenia

The lockdowns in Belgium and several American states (California and New York
in particular) as a result of the COVID-19 pandemic have had a significant
impact on the SARA-INT study.

Biophytis has had to adapt the SARA-INT protocol in order to ensure the
continuity of the trial, while preserving the health of patients and adapting
to the restrictions on movement imposed by governments and health authorities.

This has been achieved by:
* closing all on-site activities
* organizing patient follow-ups to take place at home.
* expanding the treatment from 6 to 9 months for some patients

Most sites have been reopened and the majority of the patients have completed
the study. The last patient out from the SARA-INT study is now expected in the
coming weeks. The topline results are expected in H1 2021.

MYODA clinical program in Duchenne muscular dystrophy (DMD)

The MYODA clinical program is a global, double-blind, placebo-controlled,
group-sequential, Phase 1-3 clinical study, to evaluate the safety and efficacy
of a pediatric formulation of Sarconeos (BIO101) in non-ambulatory patients
with DMD and signs of respiratory deterioration.

Biophytis had received an IND "may proceed" letter from the US FDA and approval
from the Belgian regulatory agency, Federal Agency for Medicines and Health
Products (FAMHP), to start the clinical study of its product Sarconeos (BIO101)
in non-ambulatory patients with DMD. FAMHP also cleared a protocol adjustment
that changed respiratory function to the primary endpoint.

Biophytis amended the protocol to address the FDA's comments that were included
in the IND "may proceed" letter regarding the study population and the primary
endpoint. The Company will submit the revised protocol to the FDA for review.

However, due to the continued pandemic and the acceleration of COVID-19 cases
in Belgium and the US, Biophytis has decided to delay the MYODA trial, which we
hope to start in H1 2021 (pending the COVID-19 pandemic evolution and its
effects on operational capabilities).

                                      ***

About BIOPHYTIS
Biophytis SA is a clinical-stage biotechnology company specialized in the
development of therapeutics that slow the degenerative processes associated
with aging and improve functional outcomes for patients suffering from
age-related diseases, including severe respiratory failure in patients
suffering from COVID- 19.

Sarconeos (BIO101), our leading drug candidate, is a small molecule,
administered orally, being developed as a treatment for sarcopenia in a Phase 2
clinical trial in the United States and Europe (SARA-INT). It is also being
studied in a clinical two-part Phase 2/3 study (COVA) for the treatment of
severe respiratory manifestations of COVID-19 in Europe, Latin America and the
US.

A pediatric formulation of Sarconeos (BIO101) is being developed for the
treatment of Duchenne Muscular Dystrophy (DMD).

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

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 Annual
2019 Report and 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
evelyne.nguyen@biophytis.com

Media contact
Citigate Dewe Rogerson
Sylvie Berrebi/ Nathaniel Dahan/ David Dible / Quentin Dussart
mailto:biophytis@citigatedewerogerson.com
Tel: +44 (0) 20 7638 9571 / +33 (0)1 55 30 70 91

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