Apr. 07, 2008-
-Knopp Neurosciences Inc. ("Knopp") said it initiated the first Phase 2 study of KNS-760704 in patients with amyotrophic lateral sclerosis (ALS).
Additional study details are available www.clinicaltrials.gov
The study is designed as a two-part, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of KNS-760704 oral tablets. It will be conducted at approximately 20 centers in the U.S.
In Part 1 of the study, approximately 80 ALS patients from ages 21 to 80 whose symptoms started within the past two years will receive 12 weeks of treatment with low-dose, mid-dose, or high-dose KNS-760704 or matching placebo. Participants who complete Part 1 will be eligible for a Part 2 extension in which they will be re-randomized and will receive up to 28 weeks of treatment with either low-dose or high-dose KNS-760704.
Additional study details are available at www.clinicaltrials.gov.
Knopp said it plans to initiate a larger proof-of-concept study in 2009 if KNS-760704 is shown to be safe and well-tolerated in this Phase 2a study.
"Following the successful completion of our Phase 1 healthy volunteer studies in late 2007, we're pleased to be advancing KNS-760704 into clinical trials for ALS patients," said Michael Bozik, M.D., president and chief executive officer of Knopp. "This step represents another important milestone for Knopp in our efforts to develop an effective treatment for this relentless disease."
KNS-760704 is a chirally pure oral formulation of the synthetic amino-benzothiazole (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine dihydrochloride monohydrate in clinical development for the treatment of amyotrophic lateral sclerosis (ALS). Like its S(-) optical enantiomer, pramipexole dihydrochloride (Mirapex(R)), KNS-760704 has been shown to be effective in a range of neuroprotective assays. Unlike Mirapex(R), a selective, high affinity dopamine agonist approved for the treatment of Parkinson's disease, KNS-760704 exhibits very limited dopamine receptor affinity, making it possible to clinically evaluate its potential neuroprotective activity over a broad dose range. The compound's use in ALS has received orphan drug designation from the U.S. Food and Drug Administration. Phase 1 studies in healthy volunteers have been completed.