Myogen says ambrisentan meets endpoints in trial, gets $5.25 million milestone payment

By Elaine Rigoli

Tampa, Fla., April 10 - Myogen, Inc. announced positive results of the Aries-1 trial, the second phase 3 trial evaluating ambrisentan, an oral endothelin receptor antagonist in pulmonary arterial hypertension.

The delivery of the Aries-1 trial results triggers a $5.25 million milestone payment under Myogen's ambrisentan sublicense agreement with GlaxoSmithKline, according to a news release.

The trial met the primary efficacy endpoint of improved exercise capacity for both ambrisentan dose groups, with an excellent safety profile and no observed liver function abnormalities in the ambrisentan treatment groups, the release said.

Myogen said it expects to submit the ambrisentan New Drug Application to the Food and Drug Administration in the fourth quarter of 2006.

The primary endpoint was the placebo-corrected mean change in six-minute walk distance at week 12 compared to baseline.

Results demonstrated that with once-daily dosing, 10 mg of ambrisentan improved the placebo-corrected mean six-minute walk distance by 51.4 meters and five mg of ambrisentan improved the placebo-corrected mean six-minute walk distance by 30.6 meters, indicating improved exercise capacity.

For the placebo group, the mean six-minute walk distance at week 12 decreased from baseline by 7.8 meters.

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

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