Cytokinetics Inc. (NASDAQ:CYTK) fell $8.40 (65%) to $4.59 on Friday after the company said tirasemtiv, its lead unpartnered compound, missed the primary endpoint in the Phase IIb BENEFIT-ALS trial to treat amyotrophic lateral sclerosis (ALS). Twice-daily oral tirasemtiv (formerly CK-2017357) did not improve mean ALS Functional Rating Scale-Revised (ALSFRS-R) total score from baseline to week 12 vs. placebo (p=0.11). Cytokinetics said tirasemtiv "produced mixed results" on secondary endpoints of respiratory function and other measures of skeletal muscle function. The double-blind, international trial enrolled 711 ALS patients. Data are slated to be presented at the American Academy of Neurology meeting next week. From here http://finance.yahoo.com/news/cytokinetics-says-lou-gehrigs-drug-115222740.html and here http://www.biocentury.com/dailynews/topstory/2014-04-25/cytokinetics-plummets-on-tirasemtiv-miss
Concert Pharmaceuticals Inc. (NASDAQ:CNCE) said twice-daily oral CTP-499 missed the primary endpoint of improving urine albumin-to-creatinine ratio (UACR) from baseline to week 24 vs. placebo in a Phase II trial to treat diabetic nephropathy. At week 48, patients treated with CTP-499 had a smaller increase in UACR from baseline compared to placebo (p=0.097), which Concert said may indicate stabilization of UACR in patients treated with CTP-499. The double-blind, U.S. trial enrolled 182 patients with Type II diabetic nephropathy who were receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB). Data were presented at the National Kidney Foundation meeting in Las Vegas.
Concert requested an end-of-Phase II meeting with FDA to discuss the development pathway for CTP-499 and potential Phase III endpoints. CTP-499 is a deuterated analog of an active metabolite of pentoxifylline, a phosphodiesterase-4 (PDE-4) inhibitor.
From here http://www.biocentury.com/dailynews/clinical/2014-04-25/concerts-ctp-499-misses-in-diabetic-nephropathy-trial
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