AB Science

A new publication in the medical journal Muscle & Nerve validates the use of the rate of decline of ALSFR-S score (ΔFS) for the design of clinical studies and the treatment choice for amyotrophic lateral sclerosis (ALS) patient

PRESS RELEASE

A NEW PUBLICATION IN THE MEDICAL JOURNAL MUSCLE & NERVE VALIDATES THE USE OF THE RATE OF DECLINE OF ALSFRS-R SCORE (ΔFS) FOR THE DESIGN OF CLINICAL STUDIES AND THE TREATMENT CHOICE FOR AMYOTROPHIC LATERAL SCLEROSIS (ALS) PATIENTS

THIS PUBLICATION VALIDATES THE CLINICAL TRIAL DESIGN OF MASITINIB PHASE 2/3 STUDY AB10015 AND CONFIRMATORY STUDY IN ALS

Paris, May 07, 2024, 6pm CET

AB Science SA (Euronext - FR0010557264 - AB) today announced the publication of an article in Muscle & Nerve, a peer-reviewed medical journal covering neuromuscular medicine. This article, published as part of the journal’s Issues & Opinions section, discusses the merits of using the clinical parameter of delta FS (ΔFS), the slope or rate of ALSFRS-R decline over time, as a relevant tool for innovative amyotrophic lateral sclerosis (ALS) study design. The article, entitled ‘Categorization of the amyotrophic lateral sclerosis population via the clinical determinant of post-onset ΔFS for study design and medical practice’, is accessible online from the Muscle & Nerve website (https://onlinelibrary.wiley.com/doi/epdf/10.1002/mus.28101) [1].

Authored by experts in the field of ALS, the article concludes that post-onset ΔFS serves not only as a critical stratification factor and basis for patient enrichment, but also as a tool to explore differences in treatment response across the overall population for identification of preferential responder subgroups. Furthermore, because post-onset ΔFS is derived from information routinely collected as part of standard patient care and monitoring, it provides a suitable patient selection tool for treating physicians. Post-onset ΔFS (or early ΔFS), is the rate of decline of the total ALSFRS-R score (i.e., the slope of ALSFRS-R over time), calculated from the date of initial symptom onset.

These observations are highly relevant to the masitinib development program in ALS because study AB10015 was based precisely on this design strategy [2].

Professor Albert Ludolph, MD, PhD, Chairman of the Department of Neurology at the University Hospital and Medical Faculty of Ulm and senior author of this article commented: “In this article we discuss the merits of post-onset ΔFS as a tool for innovative ALS study design. ΔFS is a clinically relevant, independent predictor of survival, capable of distinguishing patient subgroups that have a different course of disease progression. Categorization of the ALS population via post-onset ΔFS is therefore an important study design consideration that may facilitate optimization of drug effectiveness and patient management, and as such is recommended for inclusion in the design of clinical trials.”