Biophytis Announces the Design of its Phase 2 OBA Clinical Study in Obesity
Biophytis has announced the design of its Phase 2 OBA clinical study in obesity, focusing on BIO101 (20-hydroxyecdysone). The study will evaluate BIO101 in obese patients treated with GLP-1 RAs and a hypocaloric diet. CEO Stanislas Veillet highlighted the potential market for obesity treatments and the opportunity for BIO101 to preserve muscle function in these patients. The double-blind, placebo-controlled study will involve 164 patients and assess muscle strength, 6-minute walking distance, and various performance tests. The IND filing is expected soon, with the study starting mid-2024 and initial results in 2025.
- Biophytis is advancing to Phase 2 clinical trials with BIO101, showing developmental progress.
- The study targets a significant medical issue, obesity, which has a large potential market.
- 164 patients will be enrolled, increasing the statistical power of the study results.
- Double-blind, placebo-controlled design enhances the credibility of the study.
- Primary endpoint focuses on muscle strength, a critical factor in obesity treatment.
- Combination with GLP-1 RAs and hypocaloric diet offers a comprehensive treatment approach.
- Expected IND filing indicates regulatory progress and adherence to clinical trial protocols.
- Projected start in mid-2024 with results anticipated in 2025 provides a clear timeline for investors.
- Secondary outcomes include various performance tests and biomarkers, offering detailed efficacy data.
- The study's success is contingent on obtaining regulatory approvals, which introduces risk.
- Initial results are not expected until 2025, implying a long wait for potential market impact.
- The need for a double-blind, placebo-controlled design may increase costs and complexity.
- There is inherent uncertainty in clinical trials, with no guarantee of positive outcomes.
- The market already has established obesity treatments, presenting competitive challenges.
Insights
Biophytis' announcement regarding the design of its Phase 2 clinical study for BIO101 (20-hydroxyecdysone) in obesity is noteworthy. This drug candidate is aimed at preserving muscle function in obese patients, often a significant concern in weight-loss treatments, especially when using GLP-1 RAs (Glucagon-like peptide-1 receptor agonists). This treatment targets a dual benefit: aiding weight loss and maintaining muscle strength, which is important for overall health and mobility.
From a clinical standpoint, the primary endpoint being muscle strength measured by knee extension is a sound choice as it directly relates to functional mobility and quality of life. Additionally, secondary outcomes such as the 6 Minute Walking Distance and muscle mass assessments provide comprehensive insights into the drug's effectiveness. If successful, BIO101 could fill an important gap in obesity treatment by focusing on muscle preservation.
For retail investors, the key aspects to monitor are the progression of the IND filing and the commencement of the OBA Phase 2 study, as these milestones will be pivotal for assessing the drug's future prospects. The expected timelines also provide a clear roadmap, with initial results anticipated in 2025, allowing investors to gauge short-term versus long-term gains.
The strategic implications of Biophytis' Phase 2 clinical study design are significant for its market positioning. Entering the obesity treatment market, especially with a focus on muscle preservation, could set BIO101 apart from other weight-loss drugs, which often neglect this aspect. The potential market for obesity treatments is vast, given the rising prevalence of obesity globally. Successfully positioning BIO101 in this market could provide substantial revenue streams.
However, it's essential to weigh the potential benefits against the inherent risks. Clinical trials are expensive and time-consuming and there's always uncertainty regarding outcomes. Investors should be mindful of the financial implications of prolonged trials and potential regulatory hurdles.
Short-term, the IND filing and study initiation could create positive momentum for Biophytis' stock, reflecting investor confidence. However, the real value lies in the long-term results, expected in 2025. Positive trial outcomes could significantly enhance Biophytis' valuation, while any setbacks could negatively impact investor sentiment.
PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / May 14, 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 the design of its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone).
BIO101 (20-hydroxyecdysone) will be evaluated in obese patients treated with GLP-1 RAs, together with hypocaloric dieting. The OBA phase 2 study will test the efficacy and safety of BIO101 (20-hydroxyecdysone) in patients with obesity and overweight with secondary comorbidities, who are starting treatment with GLP-1 RAs for weight loss.
Stanislas Veillet, CEO of Biophytis, stated: "It is crucial for Biophytis to position itself on this gigantic medical challenge which also presents a great potential market. We believe BIO101 (20-hydroxyecdysone) has the potential to be the molecule of choice for preserving muscle function in patients suffering from obesity who are treated for weight loss with GLP-1 RAs. We are confident that our drug candidate,subject to regulatory approvals, could enter into a phase 2 clinical trial mid 2024 and that first results could be reported in 2025".
The OBA Phase 2 study is a double-blind, randomized, placebo-controlled clinical study in which 164 patients are planned to be enrolled with obesity (BMI ≥30) or overweight (BMI ≥27 with one or more sequalae e.g. diabetes, hypertension) at the start of treatment with GLP-1 RAs in combination with hypocaloric diet. Double-blind treatment with 350 mg BID of BIO101 (20-hydroxyecdysone) will be given for 21 weeks.
The primary efficacy endpoint is muscle strength as measured by knee extension, and important secondary outcomes include 6 Minute Walking Distance and other performance tests, muscle strength normalized to lean body mass, appendicular lean mass and fat mass, biomarkers and various Patient-Reported Outcomes (PROs).
Biophytis is preparing for filing an Investigational New Drug (IND) to start the OBA Phase 2 study in the USA in the coming weeks.
The OBA Phase 2 clinical study is expected to start mid 2024, upon regulatory approvals, with first patients expected to be treated in the second half of 2024.
First results of the safety and efficacy of BIO101 (20-hydroxyecdysone) drug candidate are expected to be available in 2025.
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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
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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