BioSenic SA, a clinical-stage biotech company specializing in autoimmune and inflammatory diseases, has announced its third-quarter business update, highlighting progress in its clinical programs and strategic initiatives. The company is actively seeking new assets through mergers and acquisitions while advancing its arsenic trioxide (ATO) platform for autoimmune disorders.
Clinical Pipeline Advancements
BioSenic's lead program focuses on the immunomodulatory properties of ATO, particularly in treating chronic Graft-versus-Host Disease (cGvHD), systemic lupus erythematosus (SLE), and systemic sclerosis (SSc). The company completed a Phase II clinical study with intravenous Arscimed® (ATO) for cGvHD, demonstrating positive results. New in-depth analysis of this data supports an optimal administration scheme for a planned Phase III trial. Medsenic received positive pre-IND response from the FDA, and the Phase III study with oral arsenic trioxide (OATO) in the first-line treatment of cGvHD is currently anticipated to start in 2024.
Expansion into SLE and SSc
BioSenic is also developing ATO for systemic lupus erythematosus (SLE) and systemic sclerosis (SSc). A Phase IIa clinical trial for SLE previously established safety and efficacy on the course of the autoimmune disease. Positive preclinical work supports a Phase II clinical trial on systemic sclerosis (SSc). Phase IIb clinical trials for SLE and SSc are in the planning stage with the protocols for both studies being ready.
Strategic M&A and Financial Outlook
In addition to its clinical programs, BioSenic is actively seeking one or more new assets through a merger or acquisition process. This strategic move aims to broaden the company's portfolio and leverage its expertise in autoimmune disease. BioSenic reported a net cash position of €0.52 million at the end of September 2024. The company anticipates sufficient cash to carry out its business objectives until the end of the year upon receipt of the next tranche of €210,000 under the existing convertible bonds program with GTO15. BioSenic will continue to require additional financing over 2025 and therefore actively evaluates various options.
Intellectual Property Protection
BioSenic continues to strengthen its intellectual property position. In August 2024, the Japan Patent Office granted a key patent to expand protection of the arsenic trioxide (ATO) platform. Additionally, the European Patent Office (EPO) granted a new EU patent to its subsidiary Medsenic for a "method for treating relapsing-remitting multiple sclerosis using arsenic trioxide".
