AB Science Revises Clinical Timeline Following GCP Inspection
The Paris-based laboratory has provided an update on its clinical programs and financial calendar following a good clinical practice inspection conducted by three health authorities. The new management's stated priority is the overhaul of its quality management system.
Trial Resumption Staggered Over 2027, Subject to Regulatory Approval
AB Science announced on September 29, 2026, a revision of its operational plan and financial calendar, following a "for cause" inspection of good clinical practice (GCP) conducted from September 21 to 25, involving five inspectors from three health authorities (France, Denmark, and Greece). The inspection report will be transmitted to the company before the end of the year.
The company indicated that its development plan will be adapted in several stages. It plans first to finalize the implementation of its new quality management system and conduct an external audit before considering the resumption of new clinical studies, work expected to be completed by the end of 2026.
The resumption of the phase 1 study in acute myeloid leukemia (compound AB8939) is expected in the first quarter of 2027, followed by the phase 3 study in amyotrophic lateral sclerosis (compound masitinib) in the fourth quarter of 2027, each subject to a favorable benefit-risk evaluation by the health authorities.
Focus on Quality System, Sickle Cell Program Maintained
According to the company, the preliminary findings communicated to it at the conclusion of the inspection reinforce the new management's decision to prioritize the overhaul of the quality management system, initiated on July 13, 2026, and the re-evaluation of clinical trial protocols.
AB Science clarified that the collaborative masitinib program in sickle cell disease, for which Assistance Publique - Hôpitaux de Paris (AP-HP) is the sponsor, is unaffected and should begin in the first quarter of 2027. Stéphane Ledermann, Chief Executive Officer, stated: "Strict and constant compliance with good clinical practices is at the heart of our project for AB Science, so that our clinical data are robust, recognized, and valued."
The half-yearly financial report as of June 30, 2026, will be made available no later than October 9, 2026, presenting the key elements of the company's new ambitions, followed by a webcast including a question-and-answer session.
