AB Science (ABSCF) claimed success Monday for its lead compound masitinib in a late-stage study involving patients with amyotrophic lateral sclerosis (ALS), but the French drugmaker did not provide any details about the drug's actual treatment effect.
Incomplete information from the trial makes it difficult to ascertain if ALS patient truly benefited from masitinib.
AB Science has a reputation for making treatment claims about masitinib which do not hold up under regulatory scrutiny. The company has tried but failed twice to win marketing approval for masitinib based on data from smaller clinical trials.
The phase III study announced Monday randomized 380 ALS patients to treatment with masitinib in combination with riluzole (an already approved ALS drug), or placebo plus riluzole.
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An interim analysis of the study conducted when half the patients reached 48 weeks of treatment showed a slowing in disease progression favoring masitinib over placebo based on the ALS disease severity score known as the ALSFRS-R. Masitinib also improved lung function in ALS patients more than placebo, AB Science says.
In its Monday press release, AB Science said the study results were statistically significant but the magnitude of the benefit provided by masitinib on any efficacy measure used in the study was not disclosed. On masitinib safety, AB Science said only that the rate of patient discontinuations and adverse events were comparable to placebo.
AB Science said it would host a webcast to discuss the ALS study "in the coming days."
In 2013, European regulators rejected AB Science's application seeking approval for masitinib in gastrointestinal cancer. In 2014, AB Science sought European approval for the same drug in pancreatic cancer but was also rejected.
AB Sciences says masitinib targets masts cells, which play a role in disease-related inflammation. The company is testing masitinib in an alphabet soup of disease indications, including cancer, Alzheimer's, multiple sclerosis, rheumatoid arthritis and asthma, in addition to ALS.
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