BioSenic releases details of optimized administration approach ahead of planned Phase 3 trial of OATO for chronic graft-versus-host disease - Seite 2

François Rieger, PhD, Chairman and CEO of BioSenic, said: "Our careful analysis of the previous Phase 2 trial clinical data, obtained using a short sequence of administration of ATO to patients affected by chronic graft versus host disease, provides additional guidance for optimizing dosage and treatment timing of ATO. We are now focused on finalizing the submission package of our Phase 3 trial using our new oral formulation for ATO, to further confirm the positive therapeutic effects revealed by our first trial on a limited cohort of patients with moderate-to-severe disease. We are committed to demonstrate the exceptional therapeutic effect of ATO, in line with all previous preclinical and clinical recent data obtained in the field of autoimmunity. It is now clear that the strongest industrial positioning for BioSenic aligns with the recently revealed therapeutic power of arsenic trioxide, the main asset promoted by our company.”

BioSenic is committed to exploiting the immune modulating potential of ATO in new ways for a range of diseases. In oncology, intravenous treatment with ATO has made acute promyelocytic leukaemia (APL) the most curable blood cancer since 2002^1,2. The company is now introducing an oral formulation of ATO under an exclusive licensing agreement from its partner Phebra for use in a one-month cycle treatment, repeated twice, which will significantly improve patient quality of life and compliance while reducing healthcare costs. BioSenic aims to better address the unmet medical need in cGvHD with this oral, take-at-home formulation, proven in earlier studies on APL patients to be safe and bioavailable compared to an intravenous delivered formulation. In addition, the company is developing other formulations to expand its potential applications into other immune-related disease areas.

Online, “Best administration schedule of ATO for optimal efficacy and safety of ATO treatment in chronic Graft versus host disease,” is available online at https://www.preprints.org/manuscript/202403.0645/v1.

¹Treatment of acute promyelocytic leukemia with arsenic trioxide without ATRA and/or chemotherapy - A. Ghavamzadeh et al - Ann Oncol (IF: 32.98; Q1). 2006 Jan;17(1):131-4.

²Single-agent arsenic trioxide in the treatment of newly diagnosed acute promyelocytic leukemia: durable remissions with minimal toxicity- Vikram Mathews et al. - Blood (IF: 22.11; Q1) 2006 Apr 1;107(7):2627-32.

About BioSenic

BioSenic is a biotech company specializing in the clinical development of autoimmune disease therapies. Following a reverse merger in October 2022, BioSenic combined its strategic positioning, key strengths and strong IP to develop products along two tracks, separately and in combination. The first platform leverages immunomodulatory properties of arsenic trioxide (ATO) for an entirely new arsenal of formulations, including oral delivery (OATO), for anti-inflammatory and anti-autoimmune indications such as chronic graft-versus-host disease (cGvHD), systemic lupus erythematosus (SLE) and systemic sclerosis (SSc). In parallel, BioSenic develops innovative products through a second platform that includes cell therapies and strong IP protection for tissue repair technologies.