Catalyst is a biopharmaceutical company focused on the development and commercialization of prescription drugs to fight addictions, manage pain, and treat diseases of the central nervous system such as epilepsy. Catalyst is developing vigabatrin (vi•gá•ba•trin, designated CPP-109 by Catalyst) for the treatment of addiction to cocaine, methamphetamine, and other addictive substances. Catalyst is also developing a more potent form of vigabatrin (designated CPP-115 by Catalyst) to combat drug addiction - including opiate addiction in managing pain - and to treat central nervous system indications such as epilepsy. Catalyst believes that it controls all current intellectual property for drugs, like CPP-109 and CPP-115, whose primary mechanism of action relates to GABA aminotransferase (GABA-AT, also known as GABA transaminase or GABA-T). Such drugs may prove effective relative to a wide spectrum of indications:
CPP-109 is Catalyst's designation for vigabatrin, a potential treatment for cocaine and other drug addictions. The FDA has accepted Catalyst's Investigational New Drug application to conduct clinical trials in the United States of CPP-109 for addictions (initially cocaine and methamphetamine) and has granted Fast Track status to CPP-109. To date, Catalyst has supported three completed human trials in Mexico. CPP-115 is one of a group of novel GABA aminotransferase inhibitors and derivatives of vigabatrin discovered by Northwestern University. CPP-115, an analog of CPP-109, is being developed by Catalyst under the patents licensed from Northwestern in August 2009. Read about Catalyst's licenses here.
Vigabatrin, also known as gamma vinyl-GABA or GVG, is marketed as Sabril® outside of North America by Sanofi-Aventis and within North America by Lundbeck Inc. Sabril is available in tablet and powder forms and used in combination therapy for specific types of epilepsy and alone in the management of infantile spasms (West Syndrome).
CPP-109 works for short-term treatment without the apparent side effects typically associated with GABA agonists. Targeting brain GABAergic systems with drugs such as CPP-109 is a potentially effective treatment for cocaine, methamphetamine and other substance dependencies.
CPP-115 has two potentially significant advantages compared to CPP-109. First, CPP-115 may not cause the visual field defects associated with chronic administration of vigabatrin and second, CPP-115 has been shown to be at least 200 times more potent than CPP-109 in both in vitro and animal model studies. The increased potency could enable the development of superior or alternative dosage forms and routes of administration. Catalyst hopes that these important benefits will allow it to develop not only next-generation addiction products, but a broad range of other central nervous system therapies, beginning with epilepsy and pain management.
In 2011, Catalyst advanced the development of CPP-115 by commencing a randomized, double-blind, single ascending dose Phase I(a) study in six cohorts of eight normal healthy volunteers to evaluate the human safety characteristics of CPP-115, including CNS side effects and respiratory and cardiovascular safety. See press release of December 13, 2011, and CPP-115: Frequently Asked Questions.
Information above taken from the Catalyst Pharmaceutical Partners Website (catalystpharma.com) on July 23rd 2012.