Catalyst Pharmaceutical Partners, Inc. today announced positive results from a series of CPP-115 preclinical safety and efficacy evaluations. CPP-115 was found to have a significantly improved retinal safety profile compared to vigabatrin. Additionally, the compound was found to be orally absorbed, not metabolized, and generally safe as determined in a battery of critical initial safety evaluations. Finally, CPP-115 induced significant responses in accepted animal models supporting potential efficacy as a treatment of both epilepsy and stimulant addiction.
Catalyst's initial evaluations compared CPP-115, vigabatrin and a placebo in an animal model optimized to assess visual safety. In this evaluation, CPP-115 was found to be significantly safer than vigabatrin, the only other known and commercially available GABA-aminotransferase inhibitor.
"The positive results from these studies represent a significant milestone for our company in that the responses in the animal models are strongly predictive of therapeutic benefit in humans," stated Patrick J. McEnany, Catalyst's Chief Executive Officer. "We are also extremely pleased that CPP-115 demonstrated a major improvement in visual safety compared to vigabatrin. The potential risk of peripheral vision loss from vigabatrin has been an important concern among patients and their physicians. Based on the strength of this and the other data found in these safety and efficacy studies, the company considers CPP-115 to be the leading candidate as a next generation treatment for addiction and epilepsy. We expect to initiate the remaining studies necessary to file an IND in the third quarter of next year."
"The effect of CPP-115 on retinal electrophysiological (ERG) responses showed significantly smaller changes from baseline than the effect of vigabatrin after both 45 and 90 days of drug exposure," said Cheryl M. Craft, Ph.D., the Mary D. Allen Chair in Vision Research at the Doheny Eye Institute and Professor of Ophthalmology and Cell & Neurobiology, Keck School of Medicine of the University of Southern California. "The observed vigabatrin treatment changes are similar to past reports of ERG deficits in individuals and in animal models, including our own published work. Therefore, these cumulative data from the current study support the hypothesis that CPP-115 caused substantially less retinal functional deficits than vigabatrin, which suggests this drug is likely to have an improved retinal safety profile compared to vigabatrin."
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