Complete ARIES 2 data presented:
>>SAN DIEGO--(BUSINESS WIRE)--May 24, 2006--Myogen, Inc. (Nasdaq: MYOG - News), a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disorders, today announced that a scientific presentation describing the effects of ambrisentan in patients with pulmonary arterial hypertension (PAH) was given at ATS 2006 -- San Diego, the annual International Conference of the American Thoracic Society.
The oral presentation highlighted efficacy and safety results from ARIES-2, the Phase 3 trial of ambrisentan in 192 patients with PAH. The data demonstrate that ambrisentan improved exercise capacity, delayed clinical worsening and improved symptoms in patients with PAH. Ambrisentan was well tolerated and was not associated with any clinically significant serum aminotransferase abnormalities or drug-drug interactions with warfarin-type anticoagulants. Myogen reported the top line results of the trial in December 2005.
Horst Olschewski, M.D., presented "Ambrisentan Improves Exercise Capacity and Time to Clinical Worsening in Patients with Pulmonary Arterial Hypertension: Results of the ARIES-2 Study." Dr. Olschewski is Professor of Medicine, Division of Pulmonology, Medical University Graz, Austria and a principal investigator for ARIES-2.
Patients in this trial were primarily women (75%). The etiology of the PAH was 65% idiopathic and 35% associated with other causes. Patients entered the trial in World Health Organization (WHO) Functional Class I/II (47%) and Class III/IV (53%). The patients were enrolled from Western Europe/Israel (52%), Eastern Europe (24%) and South America (24%). Mean six-minute walk distance (6MWD) at baseline was 348 meters +/- 84 meters.
The primary efficacy endpoint of the ARIES-2 trial was the placebo-corrected mean change in 6MWD at week 12 compared to baseline. Results of the trial demonstrated that with once-daily dosing, 5 mg of ambrisentan improved the placebo-corrected mean 6MWD by 59.4 meters (p = 0.0002) and 2.5 mg of ambrisentan improved the placebo-corrected mean 6MWD by 32.3 meters (p = 0.0219). For the placebo group, the mean 6MWD at week 12 decreased from baseline by 10.1 meters.
Improvements in time to clinical worsening compared to placebo were observed for both the 5 mg dose group (p=0.0076) and the 2.5 mg dose group (p=0.0048). Improvements in Borg dyspnea index compared to placebo were observed for both the 5 mg dose group (p = 0.0384) and the 2.5 mg dose group (p=0.0367). Improvements in SF-36 Health Survey® compared to placebo were observed for both the 5 mg dose group (p=0.040) and the 2.5 mg dose group (p=0.005). The pre-specified analysis of WHO functional class did not reach statistical significance; however, deterioration of at least one class was observed in 18% of placebo patients, compared to 5% of patients in the 2.5 mg ambrisentan dose group and 3% of patients in the 5 mg ambrisentan dose group.
The trial safety results demonstrated ambrisentan was well tolerated. The most frequent adverse event was headache, which occurred in 12.7% of patients in the 5 mg dose group and 7.8% in the 2.5 mg dose group, compared to 6.2% in the placebo group. There were four deaths in the placebo arm compared to two deaths (unrelated to drug) in the 2.5 mg ambrisentan dose group and none in the 5 mg ambrisentan dose group. Ambrisentan had no apparent effect on the activity or dosage of warfarin-type anticoagulants commonly prescribed for patients with PAH.
No patients treated with ambrisentan developed serum aminotransferase concentrations greater than three-times the upper limit of the normal range (3xULN), compared to one patient (1.5%) in the placebo group. As of May 2006, patients in the long-term follow-up study have a maximum drug exposure of 2.4 years and a mean drug exposure of one year. During this long-term treatment, the incidence of serum aminotransferase concentrations greater than 3xULN was less than 2% (0.6% confirmed upon re-test).<<
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So long term, MYOG is claiming incidence of 3xULN less than 2%. This compares favorably to Thelin's 3% at week 18. But the patient population is rather different. This time they break out the class numbers. MYOG, beaten up like everything else, is getting a little relief from this PR, but it's still well below $30 . . .
Cheers, Tuck |
