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May 19, 2008
 |  BioCentury  |  Product Development

Now it's head-to-head

In 2007, Pharmacopeia Inc. put its first internal compound into the clinic for hypertension based on the hypothesis that simultaneously targeting angiotensin and endothelin receptors with a single molecule would have a synergistic effect. The company got its proof of concept last week, reporting Phase IIa data showing PS433540 significantly improved both ambulatory and seated blood pressure in patients with mild to moderate hypertension.

The next task will be to compare the dual-acting angiotensin and endothelin receptor antagonist (DARA) with marketed drugs. It has already started, with a Phase IIb study that is comparing PS433540 head-to-head with Avapro irbesartan, an angiotensin receptor blocker (ARB) from sanofi-aventis Group and Bristol-Myers Squibb Co.

If Pharmacopeia can show superiority to marketed antihypertensives, it believes the compound could become a first-line treatment for hypertension.

Based on the strength of the Phase IIa results, "we expect the Phase IIb to show superiority to irbesartan," SVP of Clinical and Regulatory Affairs Rene Belder told BioCentury.

In the trial, PS433540 met the primary endpoint with a statistically significant reduction in mean 24-hour systolic ambulatory blood pressure measurement (ABPM) over placebo after four weeks of treatment. In 93 patients evaluable for efficacy, 200 and 500 mg of once-daily PS433540 reduced systolic ABPM by 12.2 and 14.8 mmHg vs. 0.4 mmHg for placebo (p<0.001).

PS433540 also met secondary endpoints of reducing mean diastolic ABPM and...

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