Nivelles Enterprise Court Approves BioSenic Restructuring Plan

June 14, 2024 – BioSenic, a clinical stage company focusing on severe autoimmune and inflammatory diseases, as well as cell repair, has announced that it has received judicial approval for its restructuring plan from the Enterprise Court of Nivelles. The ruling makes the plan compulsory for all deferred creditors and will be valid until June 2029.

The completion of the judicial reorganization process marks a significant milestone for BioSenic. The company's board of directors will now move to implement the approved plan and will call a shareholders' meeting to convert convertible bonds as per the agreed terms. This conversion excludes bonds subscribed by Global Tech Opportunities 15.

Professor François Rieger, President of the Board and CEO of the BioSenic Group, highlighted the challenges the company has faced since initiating the judicial reorganization procedure on October 12, 2023. With a four-month reprieve from accumulated debts, mainly inherited from Bone Therapeutics, BioSenic formulated a comprehensive plan to restructure the company and its debts to support future development. The plan received broad approval from creditors, grouped into classes of interest, which was taken into account by the Enterprise Court in its decision. Rieger expressed optimism that the company's new phase would allow it to tackle challenges typical of biotech firms in advanced clinical trials. The primary objective now is the successful completion of an international phase 3 clinical trial for graft-versus-host disease (cGvHD) and the development of projects targeting Lupus and Systemic Sclerosis.

BioSenic is a prominent biotech firm specializing in clinical assets derived from its Medsenic’s arsenic trioxide (ATO) platform. The company's autoimmune platform targets conditions such as graft-versus-host disease (GvHD), systemic lupus erythematosus (SLE), and systemic sclerosis (SSc). Following a merger in October 2022, BioSenic combined the strengths of Medsenic and Bone Therapeutics, enhancing its capabilities to develop anti-inflammatory and anti-autoimmune treatments using the immunomodulatory properties of ATO and oral ATO (OATO).

Based in Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium, BioSenic focuses on developing new anti-inflammatory and anti-autoimmune formulations. The ATO platform provides products with significant immunomodulatory effects on activated immune cells. One application is in onco-immunology for treating chronic GvHD, a common complication in long-term survival of allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Medsenic has successfully completed a phase 2 trial with its intravenous formulation, Arscimed®, which has orphan drug designation from both the FDA and EMA. The company is now preparing for an international phase 3 confirmatory study using its new, intellectual property-protected, OATO formulation. Additionally, BioSenic is targeting moderate-to-severe forms of systemic lupus erythematosus (SLE) with the same oral formulation, which has shown significant clinical efficacy and good safety on several affected organs.

Systemic sclerosis, another target for BioSenic, is a severe chronic disease that affects the skin, lungs, and vascularization. With no effective treatment currently available, positive preclinical studies in animal models have led BioSenic to plan a phase 2 clinical trial using new immunomodulatory formulations.

BioSenic's current focus is on the selective, accelerated development of its autoimmune platform. The company is also exploring renewed interest in its allogeneic cell therapy platform, originating from Bone Therapeutics, which may involve using isolated mesenchymal stromal cells (MSCs) to develop new subcellular vesicles for organ repair. BioSenic is working to determine new patentable approaches in this complex area of cell therapy.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!