Myogen says ambrisentan trials meet efficacy endpoint

By Elaine Rigoli

Tampa, Fla., May 3 - Myogen, Inc. announced results for the integrated analysis of Aries-1 and Aries-2, the pivotal phase 3 trials evaluating ambrisentan, an oral endothelin receptor antagonist, in pulmonary arterial hypertension.

The primary efficacy endpoint, placebo-corrected mean change in six-minute walk distance at week 12 compared to baseline, demonstrated a robust, dose-dependent increase in exercise capacity with statistical significance for the combined data for all doses and for each individual ambrisentan dose, according to a news release.

"Since both Aries trials achieved their primary efficacy endpoint for all three ambrisentan doses, we conducted the prespecified analysis of the integrated data generated by Aries-1 and Aries-2 to better understand the dose response for both the primary and secondary endpoints in these trials and to generate a more robust measure of the treatment effect of the 5 mg dose, the common dose in the two trials," president and chief executive officer J. William Freytag said in the release.

The trials were randomized, double-blind, placebo-controlled trials of identical design except for the doses of ambrisentan studied and the geographic locations of the investigative sites. The trials were conducted under protocols with identical inclusion and exclusion criteria.

Both trials were designed to enroll 186 patients (62 patients per dose group). Aries-1 evaluated once-daily doses of 5 mg and 10 mg of ambrisentan. Aries-2 evaluated once-daily doses of 2.5 mg and 5 mg of ambrisentan.

Myogen is a Denver-based biopharmaceutical company focused on the development of small-molecule therapeutics for the treatment of cardiovascular disorders.

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