Knopp Neurosciences to accelerate the development of KNS-760704 in ALS, says CEO of Knopp

Knopp Neurosciences Inc. announced that it received Fast Track designation from the U.S. Food and Drug Administration (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 U.S. and Europe in 2010. Subjects who 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.

The Fast Track Program was created to facilitate the development and expedite the review of new drugs with the potential to meet unmet needs in serious or life-threatening conditions. ALS is a universally fatal disease of progressive paralysis with limited treatment options.

“Knopp Neurosciences is very pleased to receive Fast Track designation and the recognition that KNS-760704 holds the potential to address unmet needs in ALS,” said Michael Bozik, M.D., president and CEO of Knopp. “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.”