Neuraltus reports Phase II data for NP001 in ALS

Neuraltus Pharmaceuticals Inc. (Palo Alto, Calif.) plans to start Phase III testing of NP001 to treat amyotrophic lateral sclerosis (ALS) in 2H13 despite reporting top-line data from a Phase II trial showing that NP001 missed the primary and secondary endpoints vs. placebo. Neuraltus said high-dose NP001 non-significantly slowed the rate of disease progression as measured by the change in slope of ALS Functional Rating Scale-Revised (ALSFRS-R), the primary endpoint, by 13% vs. the concurrent placebo group and by 19% when matched historical placebo control data were included with concurrent placebo control data. Neuraltus also said there were "trends of clinical benefit" with high-dose NP001 vs. placebo on the secondary endpoints of change in ALSFRS-R score from baseline to 6 months and a joint rank analysis of change of ALSFRS-R score adjusted for mortality. The double-blind, U.S. Phase II trial enrolled 136 patients to receive placebo or 1 or 2 mg/kg IV NP001 for six months. ...