Biophytis announces the successful industrial transfer of BIO101 (20-hydroxyecdysone) production by its service provider 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.