Biophytis Announces Filing of an IND Application with the US FDA for its Phase 2 Study in Obesity
Biophytis has submitted an IND application to the FDA for its phase 2 OBA clinical study in obesity using BIO101 (20-hydroxyecdysone). The study will evaluate the efficacy and safety of BIO101 in obese and overweight patients with secondary comorbidities. Patients will be treated for 21 weeks with GLP-1 receptor agonists and a hypocaloric diet. Primary objectives include assessing muscle strength in lower limbs, with secondary endpoints like mobility and body composition. The international study is set to start mid-2024, with first patient treatments expected in the latter half of the year. Initial efficacy results are anticipated in 2025. The principal investigator is Professor Marc-André Cornier, a renowned expert in obesity. Biophytis aims to attract potential pharma partners and position itself in a growing market projected to treat 15 million U.S. adults by 2030, worth an estimated $100 billion.
- Biophytis submitted an IND application for a phase 2 clinical trial in obesity.
- The study involves BIO101 and aims to improve muscle strength, mobility, and body composition.
- The phase 2 OBA study is set to start mid-2024, pending FDA approval.
- First patient treatments are expected in the second half of 2024.
- Initial results of BIO101 efficacy are anticipated in 2025.
- The study includes international sites and aims to broaden research capacity in Europe.
- Professor Marc-André Cornier, a leading obesity expert, will be the principal investigator.
- Biophytis targets a $100 billion market by 2030 with potential pharma partnerships.
- The study's start is subject to FDA approval, which could cause delays.
- First patient treatments will not begin until the latter half of 2024, delaying potential revenue.
- Initial efficacy results will not be available until 2025, prolonging uncertainty for investors.
- No guarantee of FDA approval, which is important for the study to proceed.
Insights
The submission of an Investigational New Drug (IND) application to the FDA for Biophytis' Phase 2 study on BIO101 is a significant step in its clinical research trajectory. If approved, the study will target a pressing issue—obesity—by evaluating the effectiveness of BIO101, particularly in conjunction with GLP-1 receptor agonists (GLP-1 RAs) and hypocaloric dieting. Given the primary focus on muscle strength improvements, the potential for BIO101 to fill a niche in obesity treatment is promising. This study's design reflects a comprehensive approach with multiple secondary endpoints like mobility and body composition, which could provide a detailed understanding of BIO101's overall impact on obesity treatment.
Furthermore, the involvement of Professor Marc-André Cornier, a prominent figure in the field of obesity, lends credibility to the study. His extensive background in endocrinology and obesity research will likely enhance the study's design and execution, ensuring high-quality, reliable results.
The reliance on several measurable outcomes, such as muscle strength (via knee extension) and mobility (6-minute walk test), allows for a robust assessment of BIO101's efficacy. These measures are standard in clinical trials related to muscle and mobility, helping to establish comparative benchmarks within the field.
Biophytis' move to file an IND application for BIO101's Phase 2 study could have meaningful financial implications. The obesity treatment market is substantial, with projections indicating a $100 billion addressable market by 2030 in the US alone. This initiative positions Biophytis strategically to capture a share of this lucrative market.
CEO Stanislas Veillet's statement highlights the large market potential and the company's commitment to accelerating development in this area. However, it is important for investors to note that the IND application is just an initial step. The road to market approval involves multiple stages of clinical trials and regulatory scrutiny, which could span several years.
Additionally, the potential to attract pharmaceutical partnerships is significant. Successfully navigating the IND phase could make Biophytis an attractive collaborator for larger pharmaceutical companies looking to expand their portfolios in obesity treatment.
From a financial perspective, while the long-term prospects are promising, investors should remain cautious of the inherent risks in biotech investments, including regulatory hurdles and trial outcomes.
PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / June 10, 2024 / 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 announces that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) regarding its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone).
The OBA study will assess the efficacy and safety of BIO101 (20-hydroxyecdysone) in patients with obesity and overweight patients with secondary comorbidities, treated for 21 weeks with GLP-1 receptor agonists (GLP-1 RAs) and undergoing hypocaloric dieting. The primary objective of the study is to assess improvements in muscle strength of lower limbs as measured by knee extension. Multiple secondary endpoints will also be explored such as mobility (as measured by the 6-minute walk test) and body composition (fat mass, lean body mass). This placebo-controlled multicenter international study is expected to start mid-2024, following regulatory approval to be received from the FDA no sooner than 30 days after the filing, with first patients expected to be treated in the second half of 2024. Biophytis is also actively engaging in the process to broaden its research capacity by including European clinical centers.
First results of the efficacy of BIO101 (20-hydroxyecdysone) are expected in 2025.
The principal investigator will be Professor Marc-André Cornier, Professor of Medicine and Director of the Division of Endocrinology, Diabetes and Metabolic Diseases at the Medical University of South Carolina. He is a worldwide recognized medical expert in the field of obesity and is currently President-Elect of the US-based Obesity Society. Professor Cornier has joined Biophytis' Scientific Advisory Board for the OBA project, already composed of Professor Dennis Villareal and Professor Francisco Guarner.
Stanislas Veillet, CEO of Biophytis, stated: "More than 15 million adults in the US will be treated with anti-obesity medications by 2030, representing
Professor Cornier is currently Professor of Medicine and Director of the Division of Endocrinology, Diabetes and Metabolic Diseases at the Medical University of South Carolina. Prior to that he was on faculty at the University of Colorado with the Division of Endocrinology, Metabolism and Diabetes until 2021.
At the University of Colorado, Dr. Cornier was the Associated Division Head for Endocrinology as well as the Associate Director and Medical Director of the University of Colorado Anschutz Health and Wellness Center. Dr. Cornier was also on staff at Denver Health Medical Center in Denver, Colorado from 1999 to 2016 as a general clinical endocrinologist and at Aspen Valley Hospital in Aspen, Colorado from 2017 to 2021.
Dr. Cornier is an active clinical and translational investigator with a primary research interest in understanding the complex regulation of food intake and body weight and in studying optimal interventions for weight management and metabolic health. He has also been involved in clinical trials for investigational treatments for lipid disorders and obesity. Dr. Cornier has been an active volunteer in important health-related associations, such as the Endocrine Society, American Diabetes Association, American Heart Association, National Lipid Association, and The Obesity Society.
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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), respiratory (Covid-19 phase 2-3 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) and the ADSs (American Depositary Shares) are listed on OTC market (Ticker: BPTSY - ISIN: US09076G4010). 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
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Nicolas Fellmann, CFO
Investors@biophytis.com
Media
Antoine Denry:
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Nizar Berrada:
nizar.berrada@taddeo.fr
+33 6 38 31 90 50
SOURCE: Biophytis
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FAQ
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