Biophytis Completes BIO101 Production Transfer to Seqens

Biophytis SA, a biotechnology company at the clinical-stage and listed on Euronext Growth Paris under the ticker ALBPS, has announced a significant milestone in the development of its therapeutic for age-related diseases. The company successfully scaled up the production of BIO101 (20-hydroxyecdysone) to industrial levels with the help of Seqens, a global player in pharmaceutical solutions and ingredients. Seqens has produced the first batch of BIO101 adhering to Good Manufacturing Practice (GMP) standards at their facility in Villeneuve La Garenne, Île-de-France. This batch is now available for Biophytis' clinical development program targeting respiratory deterioration in patients suffering from Duchenne Muscular Dystrophy (DMD).

DMD is a rare genetic disorder predominantly affecting boys, leading to severe and progressive muscle degeneration. The potential of BIO101 to enhance respiratory function and overall quality of life for non-ambulatory DMD patients in advanced stages is significant. Biophytis holds orphan drug status for DMD treatment in both Europe and the United States and has refined its clinical trial protocol accordingly. They are currently seeking partners and funding to initiate a phase 1-2 clinical trial to evaluate the pharmacokinetics, safety, and clinical efficacy of BIO101 in non-ambulant DMD patients experiencing respiratory failure.

Stanislas Veillet, CEO of Biophytis, emphasized the importance of this achievement, noting that the industrial-scale production of BIO101 by Seqens marks a critical step in developing their drug candidate. He highlighted that this success strengthens Biophytis’ capability to deliver unique therapeutic solutions and underscores their commitment to collaborating with leading partners to accelerate the development and accessibility of innovative treatments. Veillet also pointed out that this advancement paves the way for launching their clinical programs focused on Duchenne muscular dystrophy.

Biophytis specializes in creating drugs for age-related diseases, with BIO101 (20-hydroxyecdysone) being their lead product. This small molecule is currently in various stages of development for treating muscular conditions such as sarcopenia (with phase 3 trials ready) and Duchenne muscular dystrophy, respiratory issues like COVID-19 (with phase 2-3 trials completed), and metabolic diseases, including obesity (with phase 2 trials forthcoming). The company operates out of Paris, France, and Cambridge, Massachusetts, and its shares are publicly traded on Euronext Growth and the OTC market.

The successful production transfer to Seqens aligns with Biophytis' broader strategy to enhance its clinical pipeline and introduce novel therapies for age-related and genetic diseases. The collaboration with Seqens not only demonstrates the feasibility of large-scale production of BIO101 but also signifies a strong partnership aimed at advancing therapeutic solutions for patients in need. Through this development, Biophytis is positioning itself to move forward with clinical trials that could potentially bring new hope to those affected by Duchenne muscular dystrophy.