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

____________________________________________________________

   Dissemination of a Financial Wire News, transmitted by EQS Group.
   The issuer is solely responsible for the content of this
   announcement.
     ____________________________________________________________

   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