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news.Encysive Pharmaceuticals has reported top line results from its phase III safety and efficacy study of Thelin in patients with pulmonary arterial hypertension, revealing the treatment to be less effective versus placebo in the trial's primary endpoint than expected but more encouraging in secondary endpoints.
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STRIDE-4 was designed to determine whether a lower, 50mg dose of Thelin could be as effective as the 100mg dose and enrolled 98 patients in Latin America, Poland and Spain.
For the primary endpoint of six minute walk, patients treated with 100mg of Thelin improved 58m versus 22m for the 50mg dose and 34m with placebo. All other efficacy parameters trended toward significance at the 100mg dose versus placebo, while the 50mg dose showed no meaningful efficacy trends on any parameter.
Thelin continued to demonstrate a favorable safety profile. Drug therapy discontinuations and serious adverse events occurred with similar frequency in all groups. One patient in each group (three percent) experienced liver transaminase increases above three times the upper limit of normal. All three were discontinued from the study and both Thelin patients fully recovered without developing symptoms.
Bleeding adverse events were similar in all three groups with the lowest incidence occurring in the 100mg Thelin dose group. The most frequently observed adverse events in the study occurring more frequently than placebo were fatigue, edema, headache, dizziness, nasopharyngitis, dyspnea and extremity pain.
“While the placebo response on six minute walk is unwelcome, the overall performance of the 100mg dose of Thelin was as expected and leaves us feeling encouraged going into the pivotal STRIDE-2 results in February,” commented Dr Bruce Given, president and CEO of Encysive Pharmaceuticals.