AB Science announces a voluntary hold on the clinical studies of masitinib worldwide.
This decision is relevant to three studies: phase III in mastocytosis (AB15003), phase III in amyotrophic lateral sclerosis (AB19001) and phase II in COVID (AB20001). To this end, AB Science has filed or will file without delay a request for a temporary study hold in all countries where these studies are ongoing. AB Science has identified a potential risk of ischemic heart disease with masitinib. This signal was detected in a retrospective analysis of controlled and unblinded studies of masitinib. Following its own internal procedures, AB Science has decided to suspend inclusion in ongoing studies with masitinib until the investigation of this potential safety issue isfinished. AB Science is working closely with the ANSM and other regulatory agencies.