Neuraltus Pharmaceuticals just announced the results from their Phase II clinical trial of NP001 in people with ALS. For the Phase II study, 136 people with ALS were treated either with the placebo or with one of two doses of NP001. Unfortunately, the results of the study did not reach statistical significance. However, a post hoc analysis of the data from just the patients receiving the highest dose of NP001 did reach statistical significance. Of those receiving the higher dose, 27% did not have any progression in their disease for six months. Dr. Robert Miller of the California Pacific Medical Center who led the study said “the results from this study with NP001 are most encouraging, as halting or slowing the rate of disease progression in a subset of patients, as this study suggests, would translate into a clear clinical benefit for these patients.” After discussions with the FDA, Neuraltus has decided to move forward with a Phase III study of their NP001 drug for the treatment of ALS. Neuraltus plans to start enrolling patients in the Phase III study in 2013.
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