AB Science announced new data reporting long-term survival analysis of masitinib as an add-on therapy to riluzole in patients with amyotrophic lateral sclerosis (ALS) have been published in the peer-reviewed journal Therapeutic Advances in Neurological Disorders (TAND).
The survival analysis followed all patients originally randomized in study AB10015 for an average duration of 75 months from the date of diagnosis. In ALS patients with mild or moderate disease severity at baseline, it was seen that treatment with 4.5 mg/kg/day masitinib (n=50) as an add-on to standard riluzole prolonged survival by 25 months relative to those treated with riluzole alone (n=63) (median OS of 69 versus 44 months, respectively) with a 44% reduced risk of death. People with mild or moderate ALS comprised patients that had not suffered a complete loss or severe impairment of ALSFRS-related functionality at the time of masitinib treatment initiation (i.e., patients with a score of at least 2 on each ALSFRS-R individual component).
A confirmatory phase 3 study, AB19001, is underway assessing mastinib in patients with mild or moderate ALS.
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