Biophytis Presents Preliminary Analysis of SARA-OBS study at the 12th Annual
Congress of The Society on Sarcopenia, Cachexia and Wasting Disorders (SCWD) in
Paris (France), Cambridge (Massachusetts, United States), December 9, 2019,
8:00 a.m. CET - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage
biotechnology company with a primary focus on the development of its lead drug
candidate, Sarconeos (BIO101) for the treatment of neuromuscular diseases,
today announces the presentation of the preliminary analysis of the SARA-OBS
observational study, at the 12th international SCWD conference on cachexia,
sarcopenia and muscle wasting which took place in Berlin, Germany, December
The presentation entitled, SARA program: Preliminary Findings & Implications
from SARA-OBS Study and Its Impact on SARA-INT study, was given by Dr. Samuel
Agus, Chief Medical Officer (CMO) of Biophytis, in the session L: Late breaking
clinical science and clinical trial update on Saturday December 7, 2019.
The preliminary analysis of the SARA-OBS observational study population showed
a rapid deterioration of the mobility in the participants as measured by the
400-meter walk test (400MWT), its primary endpoint. The results of the SARA-OBS
trial confirmed that the more stringent inclusion criteria used in the SARA-OBS
study and in the on-going Phase 2b SARA-INT trial lead to the selection of
patients that are at a higher risk for mobility disability. This is in contrast
to previous sarcopenia studies where a much broader population has been
These preliminary findings from the SARA-OBS study also mean that if Sarconeos
(BIO101) is indeed beneficial for these patients, a larger difference will be
seen between the treated participants and those who received placebo.
Dr Samuel Agus, CMO of Biophytis, said "We are pleased to have the opportunity
to present the SARA-OBS preliminary analysis at SCWD. The SARA-OBS study was
designed to characterize a population of sarcopenic patients to be included in
the SARA-INT Phase 2b study and the preliminary data shows that we are
recruiting the right patient population, namely patients with severe sarcopenia
that are at a high risk for mobility disability. Based on these preliminary
findings we would expect the SARA-INT trial to show that Sarconeos (BIO101)
delivers a larger treatment effect versus placebo than initially anticipated.
These data provide us with greater confidence that the SARA-INT study will
deliver a positive outcome and further emphasizes the potential of Sarconeos
(BIO101) as a treatment for neuromuscular diseases."
Biophytis filed a protocol amendment with the U.S. Food and Drug Administration
(FDA) and the Belgian regulatory agency, L'Agence fédérale des médicaments
et des produits de santé (AFMPS) to optimize the SARA-INT Phase 2b clinical
trial for sarcopenia, based on the findings from the SARA-OBS study. The
company is currently awaiting clearance of this amendment.
The SARA-OBS clinical study evaluated the mobility, strength and physical
activity of up to one hundred sarcopenic patients recruited from a dozen
clinical centers in the U.S., Belgium, France and Italy over a 6-month period.
The study has been designed to characterize a population of sarcopenic patients
to be included in the SARA-INT study Phase 2b. The recruitment was carried out
following criteria defined by the Foundation for the National Institutes of
Health: 6mn walk test, 400 meters gait speed test, electronically recorded
patient-reported outcomes (ePROs): SF-36 QOL questionnaire, measures of muscle
strength and muscle mass, plasmatic biomarkers.
Sarcopenia is an age-related degeneration of skeletal muscle, which is
characterized by a loss of muscle mass, strength, function and mobility
disability, and increased risk of adverse health events and potential death
resulting from falls, fractures, and physical disability. There are currently
no approved drug treatments for sarcopenia, which has become the focus of
increased research aiming to improve diagnosis and treatment. Sarcopenia is
highly prevalent in the elderly (over 65) with an estimated prevalence between
six and 22 percent.
Biophytis is a clinical-stage biotechnology company focused on developing
therapeutics that slow the degenerative processes associated with aging and
improve functional outcomes for patients suffering from age-related diseases,
with a primary focus on neuromuscular diseases. Biophytis' lead drug candidate,
Sarconeos (BIO101), is an orally administered small molecule, which is
currently in a Phase 2b clinical trial for sarcopenia (SARA-INT) in the US and
Europe. A pediatric formulation of BIO101 is being developed for the treatment
of Duchenne muscular dystrophy (DMD), which Biophytis expects to be ready to
enter the clinic for DMD in 2020, subject to regulatory approval. Biophytis'
preclinical drug candidate, Macuneos (BIO201), is an orally administered small
molecule in development for the treatment of retinopathies, including dry age-
related macular degeneration (AMD) and Stargardt disease. Biophytis is
headquartered in Paris, France, and has offices in Cambridge, Massachusetts.
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ALBPS - ISIN: FR0012816825). For more information please visit
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