Catalyst Pharmaceutical Partners ($CPRX) says that its cocaine addiction therapy flopped in a Phase IIb study, missing primary and secondary endpoints and triggering a collapse in its share price, which tumbled 65% on the news.
The small Coral Gables, FL-based biotech says that CPP-109 (vigabatrin) did not beat out a placebo in keeping subjects cocaine free during a two-week treatment period. Secondary endpoints, including a goal of seeing more negative results for cocaine in urine, also flunked out. And the only question now is what steps, if any, are left to take.
"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," said CEO Patrick J. McEnany. "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."
McEnany says that in the meantime the biotech will focus on another trial for CPP-109 for Tourette's Disorder as well as Firdapse for the treatment of Lambert-Eaton Myasthenic Syndrome and CPP-115 for infantile spasm. Investors weren't in a patient mood, though. The company's shares collapsed quickly on the failure, dropping to 54 cents in pre-market trading.
- here's the press release