Knopp Neurosciences (Knopp) has received Fast Track designation from the FDA for the development of KNS-760704 in amyotrophic lateral sclerosis (ALS).
Knopp has completed the randomized, placebo-controlled portion of its phase 2 studies of KNS-760704 in 102 ALS patients and expects to initiate phase 3 studies in the US and Europe in 2010.
The subjects who have completed the phase 2 program were offered enrollment in an ongoing, 48-week open-label safety extension in which all participants are receiving the highest dose tested of KNS-760704.
Michael Bozik, president and CEO of Knopp, said: “Knopp is very pleased to receive Fast Track designation and the recognition that KNS-760704 holds the potential to address unmet needs in ALS. We are pursuing every available opportunity to accelerate the development of KNS-760704, and will take full advantage of the opportunities under Fast Track to work with the FDA in designing a program to demonstrate the drug’s safety and efficacy.”