Pharmacopeia Announces Positive Results from Phase 1 Multiple Ascending Dose Study of PS433...( Pharmacopeia Elects to Expand...),Health

Pharmacopeia Elects to Expand Study to Include 1,000 mg Dose

PRINCETON, N.J., Sept. 12 /PRNewswire-FirstCall/ -- Pharmacopeia (Nasdaq: PCOP), an innovator in the discovery and development of novel small molecule therapeutics, today announced that based on initial results from the Company's Phase 1 multiple ascending dose (MAD) study of its lead internal product candidate, PS433540 (DARA), no safety or tolerability issues were observed with any of the doses under evaluation. As a result, the study will be expanded to include a 1,000 mg dose. This study designed to evaluate 14 days of daily dosing in healthy volunteers, has already completed evaluation of 50, 100, 250 and 500 mg doses of PS433540. The Company expects to report findings from the 1,000 mg dose later this year.

"The purpose of a multiple ascending dose study of this nature is to determine the maximally tolerated dose of a compound in healthy volunteers. Since we did not reach that threshold with this study's original four doses, we've decided to expand the trial and evaluate this fifth dose level," stated Rene Belder, M.D., Pharmacopeia's Vice President of Clinical and Regulatory Affairs. "The fact that this compound appears safe and well tolerated at a wide dose range will provide added dosing flexibility for subsequent clinical trials."

In addition, results from the initial Phase 1 trial of PS433540, a single ascending dose (SAD) study, indicated that the compound was well tolerated at all six doses administered, while also suggesting that PS433540 possesses a half-life that is consistent with once daily oral administration.

PS433540 is a dual-acting angiotensin (AII) and endothelin (ET1) receptor antagonist that is being dev
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