Biophytis Obtains IND Approval from the FDA to Start its Phase 2 OBA Study in Obesity

Rhea-AI Summary

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.

Positive

• FDA approval for phase 2 OBA study.
• Potential market growth to $100 billion by 2030.
• Partnership with Blanver in Latin America.

Negative

• Dependence on funding and partnerships to complete the study.

Insights

Medical Research Analyst

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.

Financial Analyst

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 $6 billion in 2023 to $100 billion by 2030 at a 42% annual growth rate, the potential market for BIO101 is enormous. If the study yields positive results, it could substantially enhance Biophytis' valuation and attract strategic partnerships or acquisitions. This could lead to significant capital inflows, enabling further research and development.

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.

Market Research Analyst

Biophytis' entry into the obesity treatment market with BIO101 targets a rapidly growing sector. The projected market size of $100 billion by 2030 signifies vast opportunities for innovative therapies that address both weight loss and muscle preservation. This dual focus is relatively unique and could differentiate BIO101 from existing treatments, making it attractive to both consumers and healthcare providers. Partnering with a high-profile expert like Professor Marc-André Cornier lends credibility to the study and can enhance its marketability.

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 $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."

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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

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

SOURCE: Biophytis

View the original press release on accesswire.com

FAQ

What is the latest update on Biophytis' phase 2 OBA study?

Biophytis received FDA approval to start its phase 2 OBA study in obesity with BIO101 (20-hydroxyecdysone).

When will Biophytis begin its phase 2 OBA study in obesity?

The phase 2 OBA study will start mid-2024 in the USA.

Who is the principal investigator for Biophytis' phase 2 OBA study?

Marc-André Cornier, a renowned expert in obesity, is the principal investigator.

What are the primary and secondary endpoints of Biophytis' phase 2 OBA study?

The primary endpoint is muscle strength improvement in lower limbs. Secondary endpoints include mobility and body composition.

When are the preliminary results of Biophytis' phase 2 OBA study expected?

Preliminary results are expected in 2025.

What is the market potential for obesity treatments according to Biophytis?

The obesity treatment market is projected to grow from $6 billion in 2023 to $100 billion by 2030.