BioSenic releases details of optimized administration approach ahead of planned Phase 3 trial of OATO for chronic graft-versus-host disease

INSIDE INFORMATION

• New data builds on earlier findings from a post-hoc Phase 2 analysis that helped reposition BioSenic’s oral arsenic trioxide (OATO) program for pivotal trials.
• Data to be submitted for peer-reviewed publication.

Mont-Saint-Guibert, Belgium, 12 March 2024, 7.00 am CEST – BIOSENIC (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, today announces the publication of an open-access article describing an optimized schedule for administration of oral arsenic trioxide (OATO) treatment for chronic graft-versus-host disease (cGvHD), based on an earlier post-hoc analysis of Phase 2 data. The schedule will play an important role in the protocol for BioSenic’s forthcoming pivotal Phase 3 clinical trial.

GvHD is a common occurrence following allogeneic hematopoietic stem cell transplantation, used to treat a range of blood and immune diseases, including several leukaemias and lymphomas. Standard treatment begins with corticosteroids, with mixed outcomes, and those with a chronic form of GvHD may need to continue treatment for years, highlighting the clear unmet need for better treatment. BioSenic previously conducted a Phase 2 clinical trial of intravenous ATO in cGvHD treatment following stem cell transplant, with results showing that the first-line use of ATO and corticosteroids in patients with moderate to severe disease is associated with both a high clinical response rate and less need for corticosteroids.

Last year, BioSenic announced the results of an additional, observational post-hoc analysis of the full set of clinical data from the Phase 2 trial, improving the overall understanding of clinical response, safety (SAE/AE related to ATO) and cGVHD severity evolution after short cycle(s) of ATO treatment. It shows that the risk of loss of overall response over time is greater in patients who received only one cycle of ATO since they are in partial or complete remission at week 6 post-treatment compared to patients who received two cycles of second-line treatment. The use of 2 cycles of 4 weeks each, separated by a rest period of 4 weeks on ATO at 0.15mg/kg/day, should be optimal for the future treatment of cGvHD patients. The therapeutic schedule of the upcoming Phase 3 trial will be adapted thanks to a recent advance that allowed for an oral ATO formulation that can be taken at home.