Catalyst Pharmaceutical Partners' (CPRX) badly battered shares skyrocketed 86 percent after the developer announced that a close analysis of data from a failed mid-stage clinical trial inspired the company to continue the clinical development of CPP-109 for cocaine and meth addication. And a number of analysts endorsed the move.
Coral Gables, FL-based Catalyst said its decision to continue the development of the lead drug for both indications was supported by a panel of experts who recently met and agreed with the company's conclusion that there was sufficient evidence of safety and efficacy to justify further development of CPP-109, based upon the Phase II trial data and previously published studies of vigabatrin to treat addiction.
"The CPP-01004 clinical trial was a landmark first-in-class U.S. study and to our knowledge, the first large trial conducted in cocaine-dependent subjects of an orally administered medication in which extensive post-hoc objective measurements of medication levels in subjects to verify compliance were performed," said Douglas Winship, Catalyst's VP of regulatory operations. "Unfortunately, due to the significantly lower verified actual compliance we found in our trial, there was insufficient power to detect a statistically significant difference between CPP-109 and placebo on the primary or secondary efficacy outcomes. We will continue to complete additional analysis as part of our goal to present our results at appropriate medical conferences in the coming months."
"The hope of developing a successful medication for the treatment of addiction has been the "Holy Grail" for many biotech and pharma companies over the years," reported Merriman Curhan Ford. "We believe Catalyst still has the potential to develop CPP-109 into a successful treatment for cocaine and methamphetamine addiction."