Catalyst's cocaine addiction med fails mid-stage trial

Catalyst Pharmaceutical Partners says its lead drug candidate CPP-109, a treatment for cocaine addiction, failed to meet its primary endpoint in a mid-stage trial. Results from the trial did not show that, when compared with the placebo group, a significantly larger proportion of patients taking CPP-109 were cocaine-free during the last two weeks of treatment. The Coral Gables, FL-based company says it is still analyzing results for the secondary endpoints and safety data, and there were no serious adverse events reported. The company will decide what to do with the drug candidate once it has completed its analyses next quarter.

"We are obviously disappointed in the cocaine trial results, given the positive results of three prior human trials and numerous animal studies," Patrick J. McEnany, Catalyst Chairman, President and CEO, said in a statement.  "However, we are not ready to abandon our view that CPP-109 has the potential for use in treating cocaine addiction, which still represents a significant unmet medical need."

Another mid-stage trial for CPP-109 was cut down to a proof-of-concept study after enrollment was halted in March to conserve cash. The study had about 55 patients enrolled. Data from this study is expected in the third quarter as well.

In March, Catalyst said that with the revamping of its CPP-109 development, the company would have enough cash on hand to complete the data evaluations and continue operations into 2010. CEO McEnany reaffirmed that today: "As previously reported, we have sufficient cash to complete the analysis of the results from our cocaine trial, to complete our methamphetamine proof-of-concept study and to continue our operations through the end of 2010 without additional funding. As a result, we believe that we have sufficient financial and human resources to pursue a variety of strategies, which we will discuss in detail as they are developed."

- here's the Catalyst release

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