Catalyst Pharmaceutical Partners Inc. announced positive results from a Phase 1a study to evaluate the safety, tolerability and pharmacokinetic (PK) profile of CPP-115, a novel small molecule drug candidate for the potential treatment of epilepsy (initially infantile spasms), cocaine addiction and other select CNS indications.
The study results demonstrated that CPP-115 was well tolerated at all six doses administered. This Phase 1a study is also the first step of an infantile spasms clinical development plan that was discussed with the U.S. Food and Drug Administration’s (FDA) Division of Neurology Products during a pre-IND meeting in October 2011.
“The positive results of our CPP-115 first-in-man study mark an important initial milestone toward our goal of becoming a leading CNS specialty pharmaceutical company,” said Patrick J. McEnany, Chief Executive Officer of Catalyst. “The results of the study are promising and are consistent with our preclinical findings. We believe that CPP-115 has the potential to address important unmet needs in both epilepsy and addiction, highlighted by its orphan designations in the United States (infantile spasms) and European Union (West Syndrome), as well as its Fast Track status for cocaine addiction in the United States.”
Date: May 22, 2012
Source: Catalyst Pharmaceutical Partners Inc.
Filed Under: Drug Discovery