BioSenic (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell repair therapy, today announces the filing of the continuation patent application US 18/763,376 with the United States Patent & Trademark Office (USPTO) to provide protection for the use of arsenic trioxide (ATO) for the prevention and treatment of sepsis syndrome.

The patent application seeks to cover the use of Medsenic’s ATO platform, to prevent or alleviate the cytokine storm associated with systemic infections of various origins but sharing a common set of key symptoms (such as persistent hypotension, hyperthermia or hypothermia, leukocytosis or leukopenia, and thrombocytopenia) with dramatic short-term health consequences. Similar protection may lead to the filing of further specific divisional applications, in particular at the European Patent Office (EPO).

Medsenic SAS, subsidiary of BioSenic SA, is exploring the therapeutic use of ATO in several indications with clinical success. The company is also making significant progress in elucidating the mechanisms by which ATO modulates immune responses and the ability of certain metal ions to enhance this therapeutic potential. The ever-growing intellectual property portfolio is part of a strategy to build strong and meaningful protection around its lead product, ATO, paving the way for clinical and commercial development by the company and its partners, particularly in the field of autoimmunity.

The new patent, now being extended by Medsenic in the USA, covers two main areas of immediate application. The first is in immune- and autoimmune-related diseases – specifically BioSenic’s current lead project, chronic GvHD, and later systemic sclerosis and systemic lupus erythematosus. The second is oncology, where ATO has already demonstrated exceptional results in patients, including complete remissions in acute promyelocytic leukaemia. The growing patent family will support Medsenic/BioSenic’s plans for international clinical trials in pathologies with unmet medical needs. The company’s long-term goal is to seek market access approvals for its various formulations, optimizing the original properties of arsenic salts, alone or in combination.

François Rieger, PhD, Chairman and CEO of BioSenic said: “The current effort to improve the field of indications and a broader intellectual property for the use of original formulations and composition of matter related to the extraordinary properties of arsenic salts should give a dramatic impetus to the clinical and commercial development of the company. Arsenic salts are now found to exhibit critical and very original biological properties that should help provide new ways to treat diseases of the immune system and, further, cancer conditions with no effective medical treatment. It is of great interest that pharmacological formulations containing arsenic salts are often found to redirect organisms towards normal functioning of various cells and organs and restore homeostasis. We are delighted to be opening new chapters in the continuing global effort to control chronic or fatal diseases for which there is no real cure.”

The expected availability of both an intravenous and an oral formulation combining arsenic and copper puts BioSenic in a unique position to build on preclinical successes in chosen areas of applications. Medsenic/BioSenic should be able to continue a successful clinical development involving proprietary original formulations with arsenic and new active ingredients such as metal ions- increasing the efficacy of its products and minimizing side effects.

Medsenic’s worldwide patent family already includes a patent granted by the European Union Intellectual Property Office (EP3972613) in April 2023, and others by the China National Intellectual Property Administration in August 2023, by the Australian Patent Office in December 2023 and by Canada in January 2024 (3,138,472).