An excerpt from the an article published August 18, 2010 in the Wall Street Journal:
Biogen and Knopp Neurosciences today announced they have entered into an exclusive, worldwide license agreement under which Biogen Idec will develop and commercialize KNS-760704 (dexpramipexole) for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, and potentially other indications.
KNS-760704 is a novel oral neuroprotective therapy under development. In a Phase 2 study of ALS patients conducted by Knopp, the compound achieved its primary endpoint evaluating safety and tolerability and showed favorable dose-related effects in preserving motor function and extending survival. KNS-760704 has received orphan drug designation from the U.S. Food and Drug Administration and the European Commission for the treatment of patients with ALS, as well as Fast Track designation from the FDA. Biogen Idec expects to initiate a Phase 3 program of the compound in the first half of 2011.
Results from the phase two study of this drug are published on-line in
The bottom line, according to a story in the Pittsburgh Post-Gazette is that “the earliest Knopp would seek FDA approval for dexpramipexole is 2013.” Two-and-half to three years seems a long ways away, but it is an encouraging development. I think it’s possible, too, that the FDA would “fast-track” the drug if phase three results warrant.
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