Pharmacopeia Announces Positive Results from Phase 1 Multiple Ascending Dose Study of PS433540 (DARA)
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 developed as a potential treatment for hypertension and diabetic nephropathy. PS433540, the first and only DARA compound in development, possesses two clinically validated mechanisms of action in a single compound. There is considerable preclinical and initial clinical data suggesting that compared to either agent alone, simultaneously blocking the actions of both AII and ET1 may provide significantly improved treatment options for several cardiovascular diseases.
ABOUT PHARMACOPEIA
Pharmacopeia is committed to discovering and developing novel therapeutics to address significant medical needs. The Company has a broad portfolio advancing toward clinical validation, both independently and with partners. Pharmacopeia's most advanced internal program is a dual-acting angiotensin and endothelin receptor antagonist (DARA) for hypertension and diabetic kidney disease for which Phase 1 clinical trials are underway. Other internal proprietary programs address primarily immunoregulation. Pharmacopeia's collaborative efforts have resulted in a portfolio that includes one partnered program currently in Phase 2 clinical trials targeting chronic obstructive pulmonary disease (COPD) and three partnered programs in Phase 1 clinical trials targeting rheumatoid arthritis, oncology, and inflammatory disease. Four additional partnered compounds are in preclinical development.
Pharmacopeia's current strategic alliances are with Cephalon, GlaxoSmithKline, Organon and Wyeth.
surf's up......crikey
