Specialty pharmaceutical company Ventrus Biosciences Inc. (VTUS: Quote), which is focused on developing prescription drugs for gastrointestinal disorders, on Monday said its late stage study of iferanserin (VEN 309) in patients with hemorrhoidal disease failed to meet its endpoints.
Ventrus said it has no immediate plans to continue development of VEN 309, resulting in a reduction in expenses.
The pivotal phase 3, randomized, double-blind, placebo-controlled clinical trial failed to demonstrate an improvement for therapy, in either treatment arm, over placebo for the primary and secondary endpoints, the company said.
Adverse events were similar for the three treatment arms, with 6 severe adverse events reported, none of which were deemed to be related to study drug.
Ventrus said it intends to analyze the totality of its Phase 3 data further, but 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.
Russell Ellison, Chairman and Chief Executive Officer of Ventrus, said, "The outcome of our Phase 3 study comes as a surprise and a disappointment, particularly given the strong evidence of activity in our Phase 2 randomized study. Despite this setback, we remain excited about our pipeline and, with a strong cash position, plan to refocus our efforts on taking VEN 307 forward toward registration as a treatment for anal fissures."
"With the planned elimination of all VEN 309-related expenses, we believe the Company is sufficiently capitalized to take VEN 307 through a second Phase 3 study and to approval," the company added.
In pre-market activity, shares are currently trading at $9.20, down $3.06 or 24.96 percent.
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by RTT Staff Writer
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