BIOSENIC announced the publication of data providing additional key indications of its lead API (Active Pharmaceutical Ingredient) arsenic trioxide (ATO) to treat systemic sclerosis (SSc) in a peer-reviewed international journal. The new data, in a third valuable preclinical model, show a significant reduction in inflammatory infiltration and a strong improvement in vascular remodeling, mediated by an immune status improvement, particularly involving T-cells. These findings represent a substantial advancement in understanding of the complex interplay between inflammation-driven fibrosis and the pathophysiology of SSc.

These results give ground to the proposed clinical relevance of ATO treatment in SSc, and more generally in autoimmune pathologies, where lung is often impacted by fibrosis and vascular remodeling. In oncology, ATO is now recognized as a first-line treatment for acute promyelocytic leukaemia, with demonstrated safety and long-term remission. BioSenic had recently further demonstrated the safety and efficacy of ATO treatment in successful clinical programs targeting chronic Graft-versus-Host Disease, in a phase 2 and Systemic Lupus Erythematosus (SLE), in a phase 2a trial.

BioSenic believes that the clinical data it has helped to generate over the past decade, together with its ongoing efforts to understand the cellular pathways that are controlled by ATO administration at the right dose and time, now allow for further expansion of clinical trials targets. This applies to new indications in autoimmunity and inflammatory diseases. This is a reason why BioSenic specifically selected SSc for a systematic clinical approach to testing ATO as a novel first-in-class therapy.