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Biophytis SA (Symbol: BPTS) is a clinical-stage biotechnology company dedicated to developing drug candidates for age-related diseases. Founded in 2006 as a spin-off from Université Pierre et Marie Curie (Paris), Biophytis focuses on addressing conditions that become increasingly prevalent with aging, such as sarcopenia, dry age-related macular degeneration, and COVID-19-related respiratory issues.
The company's leading drug candidate, Ruvembri™ (20-hydroxyecdysone), has shown promising results in clinical trials. It is currently being evaluated in several rigorous studies, including the phase 3 SARA-31 study for sarcopenia and a phase 2-3 study for severe COVID-19. The SARA-INT phase 2 study demonstrated notable improvements in physical performance, evidenced by the 400 Meter Walking Test results.
Biophytis has also recently initiated the OBA clinical program, which aims to explore the efficacy of BIO101 (20-hydroxyecdysone) in treating obesity, especially in patients who are also being treated with GLP-1 receptor agonists. This program addresses the often-overlooked issue of muscle loss during obesity treatment, aiming to preserve muscle function while facilitating weight loss.
The company operates out of Paris, France, and Cambridge, Massachusetts, and is actively seeking partnerships to further develop and market its drug candidates. Biophytis' American Depositary Shares (ADS) are traded on the Nasdaq Capital Market under the ticker BPTS, while its ordinary shares are listed on Euronext Growth Paris under the ticker ALBPS.
In terms of financial health, Biophytis has successfully secured financing to sustain its activities until early 2025, despite a challenging financial environment for the biotech sector. This stable financial footing allows the company to continue its innovative work and expand its clinical programs.
Stay updated with the latest from Biophytis, including their groundbreaking research and strategic developments, by visiting their official website.
Biophytis has appointed Rob van Maanen as Chief Medical Officer and member of the Executive Committee, effective immediately. Van Maanen brings over 20 years of experience in drug development from both global pharmaceutical and biotech sectors. This announcement follows encouraging results from Biophytis's Sarconeos (BIO101) studies related to COVID-19 and sarcopenia. The company aims to advance its clinical programs with Sarconeos (BIO101) potentially reaching the market soon, emphasizing its commitment to addressing age-related diseases.
Biophytis announced that the independent DMC has recommended continuing patient recruitment for Part 2 of the COVA study without changes to the protocol after a safety review of the first 155 patients. Currently, 191 patients have been randomized across 36 centers in the USA, Brazil, France, and Belgium. The efficacy data from this cohort will be reviewed in Q3 2021, with top-line results from the full study of 310 patients expected in Q4 2021, subject to COVID-19 conditions. The study evaluates Sarconeos (BIO101) for severe respiratory issues due to COVID-19.
Biophytis has fulfilled its obligations from two Paris court judgments, involving a capital increase and share issuance to Negma Group. The company issued 4,950,000 new shares, leading to a 4.2% dilution of its capital, increasing its total shares to 122,145,455. This follows previous rulings which mandated Biophytis to pay fines totaling approximately €1.5 million and comply with share delivery orders. Biophytis intends to protect its interests regarding the legal processes involving Negma.
Biophytis has announced positive top line results from the SARA-INT phase 2 clinical trial of Sarconeos (BIO101) for age-related sarcopenia. The study demonstrated a statistically significant improvement in gait speed, measured by the 400-meter walk test, with a treatment effect of 0.09 m/s for the full analysis set and 0.10 m/s for the per-protocol population at the highest dose of 350 mg bid. Safety assessments showed a favorable profile with no serious adverse events attributed to the drug. The company plans to progress to a phase 3 study to further evaluate Sarconeos.
Biophytis SA (BPTS) announced the July 16, 2021 judgment from the Paris Court of Justice regarding its legal disputes with Negma Group Ltd. The court partially favored Negma, imposing a €1,500,000 penalty on Biophytis for non-performance and introducing a daily fine of €50,000 for further delays. The company intends to comply with the judgment while pursuing an appeal. Biophytis specializes in therapeutics that target age-related diseases, including their lead drug candidate Sarconeos (BIO101), which is undergoing multiple clinical trials.
Biophytis has released promising preclinical data for its drug Sarconeos (BIO101) against COVID-19, showing significant results in hamsters. The study indicated that daily treatment with BIO101 improved respiratory function and reduced distress indicators in infected animals. This breakthrough aligns with the ongoing Phase 2-3 COVA clinical study, which expects interim results in Q3 2021. The company is prepared to enhance production capacity upon regulatory approval.
Biophytis SA (Nasdaq: BPTS) announced key leadership changes aimed at enhancing its strategy in therapeutics for age-related diseases. Claude Allary joins as a new Board member, succeeding Jean Franchi, while Benoit Canolle is appointed Chief Business Officer. Jean Mariani will serve as interim Chief Medical Officer. Allary brings 40 years of healthcare experience, and Canolle has a strong background in pharma R&D. These appointments aim to advance the company’s clinical trials for Sarconeos (BIO101) targeting COVID-19 and sarcopenia.
Biophytis has entered into contracts with a major CDMO to manufacture registration batches of Sarconeos (BIO101) for potential Emergency Use Authorization from the FDA and Conditional Marketing Authorization from the EMA for COVID-19. The 155th patient in Part 2 of the COVA Phase 2-3 study has completed treatment, with interim analysis results expected in Q3 2021 and full results slated for Q4 2021. The company aims for commercialization to begin in early 2022, despite noting that new timelines do not affect Biophytis' overall strategy.
Biophytis, a clinical-stage biotechnology company, is set to release topline results from its Phase 2 SARA-INT study of Sarconeos (BIO101) in August 2021. This study involves 233 patients aged over 65, focusing on sarcopenia and mobility disability, measured through a 400-meter walk test. The trial successfully completed despite challenges posed by the COVID-19 pandemic, with 196 participants finishing the study. Full results will be shared at the ICSFR conference on September 29-October 2, 2021.
Biophytis SA (Nasdaq: BPTS) announces a €32 million financing agreement with Atlas to support the clinical development of Sarconeos (BIO101) for sarcopenia and COVID-19. This financing is through Bonds Redeemable in Cash and New and Existing Shares (ORNANE). Additionally, the company executed a €6 million drawdown from an existing convertible bond agreement with Atlas. The outcomes of upcoming clinical trials will be pivotal for further authorization in the U.S. and EU.
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