EPO to Grant Key European Patent to Medsenic for Arsenic Trioxide in Multiple Sclerosis

BioSenic, a clinical-stage company based in Mont-Saint-Guibert, Belgium, has announced a significant milestone for its subsidiary, Medsenic. The European Patent Office (EPO) has granted a new EU patent to Medsenic for a method of treating relapsing-remitting multiple sclerosis (RRMS) using arsenic trioxide (ATO). This patent, identified as EP18722530, builds on the preclinical studies that demonstrated the potential of ATO to delay or treat multiple sclerosis in a well-established mouse model. This model, known as Experimental Allergic Encephalomyelitis (EAE), mimics the inflammatory and degenerative properties of human RRMS.

The EPO patent will enable BioSenic and Medsenic to advance their clinical trials, particularly targeting the prevalent form of multiple sclerosis, RRMS. It follows a prior USPTO patent granted in the United States, which similarly protects the use of ATO for this application. The new European patent is expected to facilitate the development of phase 2-3 clinical trials, which are crucial for demonstrating the efficacy and safety of ATO in human patients.

BioSenic has also been actively publishing research on the mechanism of action of ATO, which underscores its immunomodulatory effects on inflammation. These findings, published in prominent international journals in 2022 and 2023, support the broader application of ATO in treating autoimmune diseases, infectious diseases, and cancer. The company is exploring various formulations of ATO, including innovative combinations with excipients or active pharmaceutical ingredients (APIs), to expand its therapeutic potential.

The newly granted EU patent signifies an essential step in BioSenic and Medsenic's efforts to address unmet medical needs in autoimmune diseases through international clinical trials. As stated by François Rieger, PhD, Chairman, and CEO of BioSenic, the patent for the 27 European countries opens new opportunities to control the pathological effects of multiple sclerosis. This effort is part of a broader strategy to provide unified treatments for diseases related to innate, adaptive, and acquired immunity, which impact a significant portion of the global population.

BioSenic focuses on developing clinical assets based on Medsenic’s arsenic trioxide platform, which targets autoimmune diseases such as graft-versus-host disease (GvHD), systemic lupus erythematosus (SLE), and systemic sclerosis (SSc). After merging with Bone Therapeutics in October 2022, BioSenic has been able to leverage the strengths of both entities to develop new anti-inflammatory and anti-autoimmune formulations using the immunomodulatory properties of ATO and oral ATO (OATO).

The ATO platform, which originates from Medsenic/BioSenic, provides active products with immunomodulatory properties essential for treating activated cells of the immune system. This platform is particularly relevant in onco-immunology, where it treats chronic graft-versus-host disease (cGvHD), a significant complication that affects the long-term survival of patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Medsenic's success in a phase 2 trial with its intravenous formulation, Arscimed®, which has orphan drug designation status by both the FDA and EMA, sets the stage for an international phase 3 confirmatory study with its new OATO formulation.

Further expanding its clinical pipeline, Medsenic/BioSenic targets moderate-to-severe forms of systemic lupus erythematosus (SLE) and systemic sclerosis (SSc). Preclinical studies have shown positive results, indicating the potential for launching phase 2 clinical protocols using new immunomodulatory formulations.

BioSenic is dedicated to advancing its research and development activities, focusing on its autoimmune platform. The company is also exploring renewed interest in allogeneic cell therapy, using isolated and purified differentiated bone marrow Mesenchymal Stromal Cells (MSCs) for potential organ repair approaches.

Overall, BioSenic and Medsenic are poised to make significant strides in treating autoimmune diseases and improving patient outcomes through innovative therapies based on arsenic trioxide.