BioSenic Unveils In-Depth Phase 2 Analysis for ATO in cGvHD Trial

On July 18, 2024, at 7.00 am CEST, BIOSENIC, a clinical-stage firm focusing on autoimmune and inflammatory diseases, disclosed the results of a fresh post-hoc analysis from its Phase 2 trial of Arsenic Trioxide (ATO) for treating chronic Graft-versus-Host Disease (cGvHD). The goal of this analysis is to fine-tune the dosage for future clinical trials. Results will be submitted for peer review before regulatory filings for trial approvals.

Medsenic's initial Phase 2 trial, named "Treatment of Chronic Graft Versus Host Disease With Arsenic Trioxide (GvHD-ATO)," spanned from 2016 to 2020 (ClinicalTrials.gov ID NCT02966301 - GMED16-001). Published in 2022 in Transplantation and Cellular Therapy, the study showed high effectiveness and reduced corticosteroid (CS) use when ATO was combined with CS, with or without cyclosporine, in moderate to severe cGVHD cases following allogeneic hematopoietic stem cell transplantation (HSCT). The primary measurement was the overall response rate (ORR) at six months, which stood at 75%, with 35% achieving complete response (CR) and 40% partial response (PR).

The new post-hoc analysis reveals that patients unresponsive after the first treatment cycle saw a 20% response rate after an additional cycle. Consequently, BioSenic will adopt a two-cycle regimen, each consisting of four weeks. The analysis also indicates that increasing the number of weekly injections could enhance treatment outcomes, maintaining safety for patients. BioSenic aims to develop an effective and safe ATO dosage to offer a viable long-term treatment for cGvHD, where current options are lacking.

In oncology, intravenous (IV) ATO has been a frontline treatment for acute promyelocytic leukemia (APL) since 2002, showing long-term remission and safety. However, IV administration, requiring extended hospitalization, is costly and inconvenient. The upcoming oral ATO, administered over two four-week cycles, promises to improve patient compliance and reduce healthcare costs. This advancement aligns with BioSenic's broader mission to develop effective treatments for autoimmune diseases with limited options.

François Rieger, PhD, Chairman and CEO of BioSenic, highlighted that their preclinical and clinical data demonstrate broader and deeper immunomodulatory properties of ATO than previously known. The ongoing analysis of clinical data is providing insights for optimizing formulations, dosages, and treatment schedules. The company is now poised to propose optimal conditions for a pivotal Phase 3 trial of ATO for cGvHD.

BioSenic, a key player in the biotech industry, focuses on developing clinical assets from Medsenic’s ATO platform. The platform targets autoimmune conditions like GvHD, systemic lupus erythematosus (SLE), and systemic sclerosis (SSc). Following its merger with Bone Therapeutics in October 2022, BioSenic has enhanced its capability to develop novel anti-inflammatory and autoimmune formulations using ATO.

Based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium, BioSenic continues to explore new applications of its ATO platform. Recent success in a Phase 2 trial with its intravenous ATO formulation, Arscimed®, has set the stage for a Phase 3 study using the new oral ATO (OATO) formulation. The company is also investigating the application of OATO for moderate-to-severe SLE and systemic sclerosis, both of which lack effective treatments. Preliminary animal studies are promising, supporting the launch of a Phase 2 clinical protocol.

BioSenic's current focus is accelerating the development of its autoimmune platform, which could potentially revolutionize the treatment landscape for these conditions. The company is also exploring new cell therapy approaches, utilizing Mesenchymal Stromal Cells (MSCs) for organ repair. BioSenic aims to develop new patented methods in this complex field of cell therapy.