BIOPHYTIS (EPA:ALBPS) - Biophytis Presents SARA-OBS study results at the Annual Conference of The Society on Sarcopenia, Cachexia and Wasting Disorders (SCWD)

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14/12/2020 08:00

Press Release

Biophytis Presents SARA-OBS study results at the Annual Conference of The
Society on Sarcopenia, Cachexia and Wasting Disorders (SCWD)

Paris (France), Cambridge (Massachusetts, United States), December 14th, 2020,
8:00 a.m. CET - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage
biotechnology company developing 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 announces the results of the SARA-OBS
observational study.

The results were presented in an e-poster at the 13th international conference
on sarcopenia, cachexia and wasting disorders (SCWD) on Saturday December 12th,
2020.

The e-poster entitled "SARA-OBS study: natural progression of sarcopenia and
sarcopenic obesity in older adults", was presented by Dr Cendrine Tourette,
Translational and Clinical Research Project Leader in Neuromuscular Diseases at
Biophytis, in the Abstract session 9: Therapeutic development (clinical) +
Therapeutic development (pre-clinical) on Saturday December 12, 2020 at 7:55 pm
CET.

The SARA-OBS study showed a rapid deterioration of the mobility in participants
as measured by two walking tests - the 400-meter walk test (400MWT) and the
6-minute walk test (6MWD). Of note, mobility disability is the primary endpoint
of the on-going SARA-INT Phase 2b clinical trial.

These results from the SARA-OBS trial demonstrated that the very stringent
inclusion criteria being used in the Phase 2b SARA-INT trial with Sarconeos
(BIO101) has selected patients at confirmed higher risk of mobility disability.
This rapid deterioration in the mobility criteria, as measured by the two
walking tests mentioned above, allows the treatment effect of Sarconeos
(BIO101) to be observed when compared to placebo in a smaller trial
population.

This approach to patient selection is an industry first, as previous sarcopenia
studies have recruited a broader patient population with differing levels of
risk in relation to mobility disability.

Dr Samuel Agus, Chief Medical Officer of Biophytis, said "We are pleased to
present the full analysis of the SARA-OBS trial at this year's virtual 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 data shows that
we have recruited the right patient population, namely patients with severe
sarcopenia that are at a high risk for mobility disability. Based on this data
we expect the SARA-INT trial to show that Sarconeos (BIO101) delivers a larger
treatment effect versus placebo. 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.
The last patient out from the SARA-INT study is expected in the coming days."

Biophytis also participated to the Symposium entitled "Update on clinical
research on sarcopenia" which took place on Saturday December 12th, 2020 from
3:30 pm to 4:25 pm.

The symposium included:

- a presentation on the "Current status of clinical research targeting
Sarcopenia" by Dr Roger Fielding, Director and Senior Scientist of the
Nutrition, Exercise Physiology, and Sarcopenia (NEPS) Laboratory at the Jean
Mayer USDA Human Nutrition Research Center on Aging at Tufts University.

- a presentation on the "SARA program: the use of BIO101, a MAS receptor
agonist, for the treatment of sarcopenia" delivered by Dr Cendrine Tourette,
Translational and Clinical Research Project Leader in Neuromuscular Diseases at
Biophytis.

- a panel discussion chaired by Professor Bruno Vellas, Coordinator of the
geriatrics center of Toulouse University Hospital and including:
  o Dr Roger Fielding, Director and Senior Scientist of the Nutrition, Exercise
Physiology, and Sarcopenia (NEPS) Laboratory at the Jean Mayer USDA Human
Nutrition Research Center on Aging at Tufts University,
  o Dr Waly Dioh, Chief Operating Officer at Biophytis, and
  o Dr Sam Agus, Chief Medical Officer at Biophytis

The symposium was supported by an unrestricted educational grant from
Biophytis.

                                      ***

About SARA-OBS
The SARA-OBS clinical study evaluated the mobility, strength and physical
activity of 185 sarcopenic patients aged over 65 years 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 US Foundation for the National Institutes of
Health: Measurement of muscle mass by DEXA, and by a short physical performance
battery (SPPB). The following parameters are measured in this study: 6-minute
walk test (6MWD), 400 meters gait speed test (400MWT), stair climb power test,
electronically recorded patient-reported outcomes (ePROs): SF-36 QOL
questionnaire, measures of muscle strength (handgrip strength test) and muscle
mass, plasmatic biomarkers.

About Sarcopenia
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.

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
biophytis@citigatedewerogerson.com
+44 (0) 20 7638 9571 / +33 (0)1 55 30 70 91

Source: Biophytis

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BIOPHYTIS (EPA:ALBPS) - Biophytis Presents SARA-OBS study results at the Annual Conference of The Society on Sarcopenia, Cachexia and Wasting Disorders (SCWD)

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