Biotech Values

[DonShimoda]

CPRX CPP-109 Phase 2b trial did not meet the primary endpoint

Catalyst Pharmaceutical Partners Announces Top-Line Results of CPP-109 Phase II(b) Trial for Cocaine Addiction
CORAL GABLES, Fla., Nov. 8, 2012 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) today announced top-line results from its U.S. Phase II(b) clinical trial evaluating the use of CPP-109 (vigabatrin) to treat cocaine addiction. The data from the trial showed that CPP-109 did not meet the primary endpoint -- that a significantly larger proportion of CPP-109-treated subjects than placebo-treated subjects were cocaine-free during the last two weeks of the treatment period (Weeks 8 and 9). The data also showed that the two key secondary endpoints, a significantly larger increase in cocaine negative urines and a significant decrease in the weekly fraction of use days in medication-treated subjects during weeks 3-9, also were not met. The clinical trial did not reveal any unexpected "serious" adverse events.

Catalyst expects the remaining protocol-specified analyses for other secondary and exploratory clinical endpoints and safety data to be completed during the first half of next year, after all the follow-up clinical data have been received to be able to fully unblind the trial data.

Patrick J. McEnany, Catalyst's Chairman and Chief Executive Officer, commented, "We are obviously very disappointed with the top-line results from our Phase II(b) cocaine trial, particularly given the changes that were incorporated into the protocol for this trial to ensure maximum medication compliance from a more motivated patient population. Once we have the full data set, we will meet with our collaborator on the Phase II(b) trial, the National Institute of Drug Abuse (NIDA), to determine next steps, if any, in the clinical development program for CPP-109 for cocaine addiction."

Mr. McEnany continued, "In the near term, we intend to focus all of our efforts on the development of our two other product candidates: FirdapseTM for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) and CPP-115 for the treatment of infantile spasms. Both of these product candidates have received orphan drug designation and are intended to treat a rare neurological disorder. We will also monitor the results of the ongoing investigator-sponsored study evaluating the use of CPP-109 for the treatment of Tourette's Disorder to determine whether we should pursue future studies of CPP-109 with respect to that orphan indication."

http://ir.catalystpharma.com/releasedetail.cfm?ReleaseID=719702