Catalyst Pharmaceutical Partners (CPRX) is the only company developing drugs for the large unmet need of cocaine addiction with their promising CPP 109 in phase II(b) trials.
CPP 109 is on "Fast Track" with the FDA and also holds promise for the even greater problem of alcohol abuse and addiction.
The National Institute for Drug Abuse (NIDA) and the Veterans Association support Catalyst Pharma and the current clinical trials.
Shares of Catalyst Pharmaceutical Partners have doubled from their low in the past few months, and trading volume is increasing substantially. Catalyst also appears to be breaking out of a long-term downtrend since June 2011 and has built a strong base at $1 for the past two years that was only penetrated for a very brief 8 weeks recently.
This increasing activity could all be explained by a recent Catalyst press release where Patrick J. McEnany, Chief Executive Officer of Catalyst said:
We are pleased that we will be able to report the top-line results of our CPP-109 Phase II(b) clinical trial sooner than expected. We are committed to bringing safe and effective breakthrough products for the treatment of cocaine addiction to the market as quickly as possible, and the earlier reporting of these data is consistent with that philosophy.
Validating Institutional support for CPP109
Catalyst's lead drug, CPP109 is on fast track in a Phase IIb clinical trial for cocaine addiction. While results of this trial are not yet known, a previous trial published in the American Journal of Psychiatry demonstrated statistically significant results for CPP 109 not only for cocaine addiction, but also for alcohol addiction.
Results from the current phase II(b) trial underway are ahead of schedule and are expected in September this year. Prior results were so promising that the National Institute on Drug Abuse (NIDA) signed a definitive Clinical Trial Agreement (CTA) with Catalyst to jointly conduct the current U.S. Phase II(b) clinical trial evaluating CPP-109, Catalyst's formulation of vigabatrin, for the treatment of cocaine addiction. As part of the CTA, NIDA, under their agreement with Veteran's Administration Cooperative Studies Program, will provide substantial resources for the estimated $10 million trial cost. Catalyst will contribute approximately $2.8 million in resources.
About CPP 109
CPP 109 is repurposed vigabatrin that was originally approved for epilepsy 20 years ago in Europe as an anti epileptic drug. Sanofi (SNY) sold the drug under the name of "Sabril".
CPP109 has been shown in previous clinical trials to be effective against cocaine addiction (and alcohol addiction).
Catalyst owns the worldwide rights to CPP 109 for all forms of addiction and obsessive-compulsive disorders.
Since CPP 109, aka vigabatrin or sabril is repurposed and was previously approved by the FDA, it qualifies as a 505 b2 filing pathway that allows use of the safety data from the previous submission resulting in significant time and cost savings.
CPP 109 and CPP 115
Catalyst is also developing CPP115 to replace CPP109 in 2018 when the patent expires. CPP115 is 200 times more potent than CPP109 and has even greater safety. The patent for CPP115 runs to 2028.
CPP 109 and CPP 115 both work by turning down the volume on the reward center of the brain so that the patient no longer experiences the reward from the drug. See "How CPP 109 and CPP 115 works".
Safety - Potential side effects
The most significant potential side effect at very large doses of CPP 109, larger than those used in clinical trials to treat cocaine addiction, have been associated with partial loss of peripheral vision. However, a scientific report in The American Journal of Ophthalmology stated:
Short-term use of vigabatrin did not cause a decrease in visual acuity or significant peripheral visual field changes in cocaine abusers. These results confirm and expand upon previously published ocular safety results obtained in a study conducted by Dr. Fechtner and colleagues (Fechtner et al., Arch Ophthalmol 2006; 124:1257-62).
CPP 109 and CPP 115 market size
The National Institute on Drug Abuse (NIDA) estimates the total cost of substance abuse in the United States at more than $484 billion per year and combined with alcohol abuse the number is staggering.
The Substance Abuse and Mental Health Services Administration (SAMHSA) estimates that in 2010, there were 1.5 million current cocaine users aged 12 or older.
SAMHSA also estimates that in 2010, nearly one quarter (23.1 percent) of persons aged 12 or older participated in binge drinking. This translates to about 58.6 million people. The rate in 2010 was similar to the estimate in 2009 (23.7 percent). Binge drinking is defined as having five or more drinks on the same occasion on at least 1 day in the 30 days prior to the survey.
These estimates are for the United States only and do not include Europe and the rest of the world.
Antabuse (Disulfiram) has been used since the 1940's and has such powerful side effects, including death, that it is very unpopular.
Pfizer (PFE) developed Oxetca which is intended to discourage opioid abuse and misuse but is not effective for addiction.
There are no approved drugs available for cocaine addiction.
Failure in the current phase II(b) trial would be a setback if efficacy is not demonstrated.
Catalyst Pharmaceutical Partners is an exciting opportunity and if results from the current trial sponsored by the National Institute Of Drug Abuse are positive, it should have a very strong impact on the price of their shares.