Ventrus (VTUS) Issues Results from Pivotal Phase 3 Trial of Iferanserin, Says Failed to Show Improvement from Therapy
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Ventrus Biosciences, Inc. (Nasdaq: VTUS) today reported that its Phase 3, randomized, double-blind, placebo-controlled clinical trial of iferanserin (VEN 309) in patients with hemorrhoidal disease did not meet its endpoints.
The Phase 3 trial randomized 603 patients to one of three, twice-daily treatment groups: 7 days of active treatment followed by 7 days of placebo, 14 days of active treatment, or 14 days of placebo treatment. Elimination of bleeding from day 7 through day 14 of treatment was the primary endpoint, with elimination of itching and pain from day 7 through day 14 as the secondary endpoints. Results of this large, well-controlled study failed to demonstrate an improvement for therapy, in either treatment arm, over placebo for the primary and secondary endpoints. Adverse events were similar for the three treatment arms, with 6 severe adverse events reported (3 treatment emergent, one in each group), none of which were deemed to be related to study drug.
While the Company intends to analyze the totality of its Phase 3 data further, it believes that current resources would be better allocated toward the planned completion of its VEN 307 (diltiazem cream) development program in anal fissures and the beginning of further development of VEN 308 (topical phenylephrine) in fecal incontinence. Consequently, Ventrus has no immediate plans to continue development of VEN 309, resulting in a reduction in expenses.
The Phase 3 trial randomized 603 patients to one of three, twice-daily treatment groups: 7 days of active treatment followed by 7 days of placebo, 14 days of active treatment, or 14 days of placebo treatment. Elimination of bleeding from day 7 through day 14 of treatment was the primary endpoint, with elimination of itching and pain from day 7 through day 14 as the secondary endpoints. Results of this large, well-controlled study failed to demonstrate an improvement for therapy, in either treatment arm, over placebo for the primary and secondary endpoints. Adverse events were similar for the three treatment arms, with 6 severe adverse events reported (3 treatment emergent, one in each group), none of which were deemed to be related to study drug.
While the Company intends to analyze the totality of its Phase 3 data further, it believes that current resources would be better allocated toward the planned completion of its VEN 307 (diltiazem cream) development program in anal fissures and the beginning of further development of VEN 308 (topical phenylephrine) in fecal incontinence. Consequently, Ventrus has no immediate plans to continue development of VEN 309, resulting in a reduction in expenses.
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