BioSenic presents successful preclinical data on its ATO medication for controlling key symptoms at the 2024 Systemic Sclerosis World Congress

PRESS RELEASE

• Preclinical data in a transgenic mouse model shows beneficial effects on various clinical symptoms analogous to those observed in human systemic sclerosis.
• Findings may further support future clinical program.

Mont-Saint-Guibert, Belgium, 20 March 2024, 7.00am CET – BioSenic (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, presented the latest data on arsenic trioxide (ATO) for systemic sclerosis (SSc) at the 8^th Systemic Sclerosis World Congress 2024. The data, obtained with the laboratory of Yannick Allanore, MD, Ph.D. from the Hospital Cochin, builds additional evidence for the use of ATO in multiple autoimmune conditions, as observed in various animal models and in recent pilot human clinical trials.

The scientific communication presented by Anne Cauvet and Pr. Allanore demonstrated the efficacy of ATO in Fra2 transgenic mice, which is used as a disease model of symptomatic SSc, a chronic autoimmune disease marked by multi-organ fibrosis. BioSenic has previously showed that ATO, a first-in-class specific immunomodulatory drug, has significant therapeutic action in humans, and the company is progressing several formulations for autoimmune diseases in clinical trials. The researchers further reported that ATO resulted in significant lung histological changes, a trend towards a decrease in various fibrotic makers and a strong reduction in vascular remodeling in the SSc mouse model. The mechanism of action of ATO appears to involve a marked counteraction of the immune activation characteristic of SSc, particularly Tcell involvement. These positive findings have encouraged BioSenic to continue studying ATO for potential use in SSc.

François Rieger, PhD, President of the Board and CEO of the BioSenic Group, said: “Our past data, including several animal models of autoimmune diseases and recent Phase 2 trials in systemic lupus erythematosus and chronic graft-versus-host-disease, have shown the remarkable therapeutic benefits of BioSenic’s liquid ATO solution for various autoimmune conditions with critical unmet medical needs. The more recent data for another serious autoimmune disease, systemic sclerosis, has given convincing preclinical evidence to support a Phase 2 trial for patients affected by this disease, which has no cure. The well-known safety of ATO’s pharmacologically active ingredient mean derived products, including an oral formulation (OATO), may follow FDA’s rapid 505(b)(2) regulatory path.”