Biophytis Obtains IND Approval from the FDA to Start its Phase 2 OBA Study in Obesity
Biophytis has received FDA approval for its phase 2 OBA study in obesity using BIO101 (20-hydroxyecdysone). The study will evaluate muscle strength improvement in the lower limbs and secondary endpoints like mobility and body composition. The trial, led by obesity expert Marc-André Cornier, will start mid-2024 in the USA and may extend to Europe. Preliminary results are expected in 2025. Biophytis aims to attract funding and partnerships, emphasizing the growing obesity treatment market, projected to reach $100 billion by 2030.
- FDA approval for phase 2 OBA study.
- Potential market growth to $100 billion by 2030.
- Partnership with Blanver in Latin America.
- Dependence on funding and partnerships to complete the study.
Biophytis' FDA approval for the Phase 2 OBA study in obesity is a significant milestone. This is because the successful completion of an IND application demonstrates that the company has met stringent regulatory requirements, paving the way for clinical trials. The study's focus on muscle strength and mobility addresses critical aspects of obesity management beyond simple weight loss. By examining how BIO101 (20-hydroxyecdysone) influences muscle mass and functionality, Biophytis is tackling a largely unmet need in obesity treatment.
Obesity treatments currently lack robust solutions for addressing muscle deterioration, a common side effect of weight loss. If BIO101 proves effective, it may set a new standard for comprehensive obesity therapies. This could provide Biophytis a competitive edge, especially as they plan to expand the study to Europe, indicating a potential for global reach.
However, the study's success depends on securing additional funding and partnerships, a common challenge for clinical-stage biotech firms. The preliminary results expected in 2025 will be pivotal in assessing the efficacy of BIO101 and the company's ability to attract further investment will depend heavily on these outcomes.
From a financial perspective, the FDA's approval of Biophytis' IND for its Phase 2 OBA study represents a noteworthy advancement. With the obesity treatment market projected to grow from
However, investors should be cautious about the inherent risks in clinical trials. Failures or delays could adversely impact Biophytis' financial stability. Additionally, the need to secure funding adds a layer of financial uncertainty. While the market potential is vast, the path to commercialization is fraught with obstacles that could affect investor returns in the short term.
Biophytis' entry into the obesity treatment market with BIO101 targets a rapidly growing sector. The projected market size of
However, it's essential to note that the obesity treatment market is fiercely competitive, with numerous players vying for market share. Biophytis will need to navigate this landscape carefully, leveraging its unique value proposition while also ensuring robust clinical outcomes. The company's ability to establish partnerships, particularly in regions with high obesity rates, will be important for long-term success.
PARIS, FRANCE AND CAMBRIDGE, MA / ACCESSWIRE / July 11, 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 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
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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, 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
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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
SOURCE: Biophytis
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