The biotechnology company Neuraltus Pharmaceuticals is initiating a second Phase II clinical trial of its candidate ALS therapy called NP001 (see April 2016 news). The drug is a small molecule that regulates activated macrophages and reduces inflammation. In a previous Phase II trial, post-hoc analysis suggested NP001 was beneficial in a subgroup of patients with elevated levels of a marker of systemic inflammation called C-reactive protein (CRP). The current study aims to test and confirm the prior results in a randomized, double-blind, placebo-controlled clinical trial of up to 120 patients in the U.S. and Canada. Drug effects will be assessed based on changes from baseline in the score of the ALS Functional Rating Scale-Revised (ALSFRS-R) and in measures of respiratory function.
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