Biophytis obtains IND approval from the FDA to start its phase 2 OBA study
in obesity
Biophytis / Key word(s): Miscellaneous/Miscellaneous
Biophytis obtains IND approval from the FDA to start its phase 2
OBA study in obesity
11-Jul-2024 / 08:13 CET/CEST
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Biophytis obtains IND approval from the FDA to start its phase 2
OBA study in obesity
Paris (France) and Cambridge (Massachusetts, USA), July 11, 2024
- 07:00am CET - Biophytis SA (Euronext Growth Paris : ALBPS),
("Biophytis" or the "Company"), a clinical-stage biotechnology
company specialized in the development of therapeutics for
age-related diseases, today announced that it has received
Investigational New Drug (IND) approval from the Food and Drug
Administration (FDA) for its phase 2 OBA clinical study in
obesity with BIO101 (20-hydroxyecdysone).
The primary objective of the study is to measure the improvement
in muscle strength in the lower limbs, as assessed by knee
extension test. Secondary endpoints will include analysis of
mobility (via the 6-minute walk test) and body composition
(assessment of fat and lean mass). A world-renowned medical
expert in the field of obesity and President-elect of the
American Obesity Society, Marc-André Cornier, Professor of
Medicine and Director of the Endocrinology, Diabetes and
Metabolic Diseases Unit at the Medical University of South
Carolina, will be the principal investigator of the phase 2 OBA
study.
Professor Marc-André Cornier commented: "I am very happy that the
IND for the phase 2 OBA clinical study with BIO101
(20-hydroxyecdysone) has been approved by the FDA. It is critical
for us to study the safety and efficacy of new therapies designed
to reduce the risk of muscle mass loss and resulting muscle
weakness with functional consequences that may be associated with
incretin-based therapies. Additionally we might observe further
weight loss over and above that obtainable with a GLP-1 RA."
The multicenter study is due to start mid-2024 in the USA and
could be extended to Europe. Preliminary results on the efficacy
of BIO101 (20-hydroxyecdysone) are expected in 2025. Biophytis is
seeking funding and partnerships to complete this study.
Stanislas Veillet, CEO de Biophytis, stated: "Obesity represents
a major medical challenge and a significant growth opportunity
for Biophytis. The obesity treatment market, estimated at $6
billion in 2023, is expected to reach $100 billion by 2030, with
an average annual growth rate of 42%. Obtaining an IND from the
FDA is a crucial step that will enable us to make rapid progress
in this indication and attract new pharmaceutical partners. We
are convinced that BIO101 could become a reference treatment for
preserving muscle mass, strength and function in obese patients
treated with GLP-1 RAs. This development has convinced our
partner Blanver in Latin America, and we are convinced that it
will attract new ones in other regions of the world where obesity
is a major health issue."
* * * *
About BIOPHYTIS
Biophytis SA is a clinical-stage biotechnology company
specializing in the development of drug candidates for
age-related diseases. BIO101 (20-hydroxyecdysone), our lead drug
candidate, is a small molecule in development for muscular
(sarcopenia, phase 3 ready and Duchenne muscular dystrophy, phase
1-2 study to be started, respiratory (Covid-19, phase 2
completed) and metabolic diseases (obesity, phase 2 to be
started). The company is based in Paris, France, and Cambridge,
Massachusetts. The Company's ordinary shares are listed on
Euronext Growth (Ticker: ALBPS -ISIN: FR0012816825). For more
information, visit www.biophytis.com
Forward-looking statements
This press release contains forward-looking statements.
Forward-looking statements include all statements that are not
historical facts. In some cases, you can identify these
forward-looking statements by the use of words such as
"outlook," "believes," "expects," "potential," "continues,"
"may," "will," "should," "could," "seeks," "predicts,"
"intends," "trends," "plans," "estimates," "anticipates" or the
negative version of these words or other comparable words. Such
forward-looking statements are based on assumptions that
Biophytis considers to be reasonable. However, there can be no
assurance that the statements contained in such forward-looking
statements will be verified, which are subject to various risks
and uncertainties. The forward- looking statements contained in
this press release are also subject to risks not yet known to
Biophytis or not currently considered material by Biophytis.
Accordingly, there are or will be important factors that could
cause actual outcomes or results to differ materially from those
indicated in these statements. Please also refer to the "Risk and
uncertainties the Company is to face» section from the Company's
2023 Financial Report available on BIOPHYTIS website
(www.biophytis.com) and as exposed in the "Risk Factors" section
of form 20-F as well as other forms filed with the SEC
(Securities and Exchange Commission, USA). We undertake no
obligation to publicly update or review any forward-looking
statement, whether as a result of new information, future
developments or otherwise, except as required by law.
Biophytis contacts
Investor relations
Nicolas Fellmann, CFO
Investors@biophytis.com
Media
Antoine Denry: antoine.denry@taddeo.fr - +33 6 18 07 83 27
Nizar Berrada: nizar.berrada@taddeo.fr - +33 6 38 31 90 50
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Dissemination of a Financial Wire News, transmitted by EQS Group.
The issuer is solely responsible for the content of this
announcement.
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Language: English
Issuer: Biophytis
14 avenue de l´Opéra
75001 Paris
France
Internet: https://www.biophytis.com
ISIN: US09076G1040, FR0012816825
EQS News ID: 1943871
End of Announcement - EQS News Service
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1943871 11-Jul-2024 CET/CEST