Biophytis Announces the Successful Industrial Transfer of BIO101 (20-hydroxyecdysone) Production by its Service Provider Seqens
Biophytis, a clinical-stage biotechnology company, announced the successful industrial transfer of its drug candidate BIO101 (20-hydroxyecdysone) production to Seqens. Seqens has produced the first GMP-compliant batch at their Villeneuve La Garenne plant, which is now available for Biophytis' clinical development program aimed at treating respiratory deterioration in Duchenne Muscular Dystrophy (DMD) patients. DMD is a severe genetic disease causing progressive muscle degeneration. The company, which holds orphan drug designation in Europe and the US for this indication, aims to assess BIO101's pharmacokinetics, safety, and clinical efficacy in a planned phase 1-2 trial. Biophytis is currently seeking partners and funding for this clinical trial.
- Successful industrial transfer of BIO101 production to Seqens.
- First GMP-compliant batch produced, ready for clinical use.
- BIO101 targets respiratory deterioration in DMD patients.
- BIO101 holds orphan drug designation in Europe and the US.
- Planned phase 1-2 trial aims to assess pharmacokinetics, safety, and efficacy.
- Dependence on partnerships and funding to initiate clinical trials.
- Potential delays if funding and partners are not secured.
Insights
The successful industrial transfer of BIO101 production is a key milestone for Biophytis, especially considering the rare and severe nature of Duchenne Muscular Dystrophy (DMD). This scale-up to industrial production paves the way for a more stable and reliable supply of the drug for clinical trials. From a clinical perspective, DMD has limited treatment options, so any potential therapy that can enhance respiratory function and overall quality of life represents a significant advancement. The Good Manufacturing Practice (GMP)-compliant batch produced by Seqens ensures that BIO101 meets the stringent quality standards required for clinical use, which is a critical step before human trials. This development supports Biophytis' goal to commence phase 1-2 trials and might attract attention from potential partners and investors in the biotechnology and pharmaceutical fields.
For investors, Biophytis' announcement signals progress in risk management and operational efficiency by successfully collaborating with Seqens for the industrial-scale production of BIO101. This collaboration mitigates potential production bottlenecks and enhances Biophytis' capability to meet regulatory and clinical demands. The mention of seeking partners and funding for the clinical trial is a important point: successful partnerships could provide necessary financial backing and shared expertise, reducing the financial burden on Biophytis. Moreover, the orphan drug designation in both Europe and the US underscores the potential for market exclusivity and pricing power, which could materially affect the company's revenue if the drug progresses successfully through clinical trials.
The industrial transfer of BIO101 marks a significant step for Biophytis in breaking into the niche market for DMD treatments. The fact that DMD mainly affects boys, coupled with the severe and progressive nature of the disease, creates a high unmet medical need. The orphan drug designation not only highlights the drug's potential impact on a small patient population but also suggests possible incentives like tax credits, grant funding and expedited review processes. This could potentially lead to a faster time-to-market and increased attractiveness to investors. By advancing to industrial-scale production, Biophytis positions itself as a serious contender in the rare disease market, setting the stage for future commercial success if subsequent clinical trials are successful.
PARIS, FRANCE AND CAMBRIDGE, MA / ACCESSWIRE / June 12, 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, announces the successful transfer of BIO101 (20-hydroxyecdysone) production to industrial scale by Seqens.
Seqens, an integrated global player in solutions and ingredients for the pharmaceutical and speciality markets, offering a broad portfolio of active ingredients, pharmaceutical intermediates and speciality products, has produced the first GMP-compliant batch of BIO101 (20-hydroxyecdysone) at its plant in Villeneuve La Garenne (Île-de-France). This batch is now available for use in Biophytis' clinical development programme to treat respiratory deterioration in patients with Duchenne Muscular Dystrophy (DMD).
DMD is a rare genetic disease that causes severe and progressive muscle degeneration, mainly affecting boys. BIO101 (20-hydroxyecdysone) has significant potential to improve respiratory capacity and quality of life in non-ambulatory patients in the advanced stages of the disease.
Stanislas Veillet, CEO of Biophytis, stated: "This is a crucial step in the development of our drug candidate. The successful transfer of production to industrial scale by Seqens strengthens our ability to provide unique therapeutic solutions. It also reflects our commitment to collaborate with leading partners to accelerate the development and availability of innovative treatments and the launch of our clinical programmes in Duchenne muscular dystrophy."
Biophytis, which has already orphan drug designation in Europe and the United States in the DMD indication and has refined its protocol, submitted to the European and American regulatory agencies, is seeking partners and funding to launch a phase 1-2 clinical trial in non-ambulant DMD patients suffering from respiratory failure. The aim of this clinical trial will be to assess the pharmacokinetics, safety and clinical efficacy of BIO101 (20-hydroxyecdysone) in this indication.
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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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