Specialty pharmaceutical company Ventrus Biosciences, Inc. (VTUS: Quote), which is focused on developing prescription drugs for gastrointestinal disorders, said Monday its late stage study of iferanserin (VEN 309) in patients with hemorrhoidal disease failed to meet its endpoints.
Following the announcement, the company's shares have plummeted $7.00 or 57.10 percent to $5.26 in pre-market activity.
The phase 3 trial of VEN 309 enrolled about 603 patients at 70 centers in the U.S., and were randomized into three arms - Iferanserin administered intra-anally twice daily for 7 days followed by placebo for 7 days, Iferanserin administered intra-anally twice daily for 14 days, and placebo for 14 days.
"We would like to thank both investigators and patients for their support and participation in this study and in the VEN 309 program. 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," Chairman and CEO Russell Ellison said in a statement.
The primary endpoint was the cessation of bleeding by the end of day 7 through day 14 and the secondary endpoints were cessation of itching and pain by day 7 through day 14.
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 New York-based company said.
VEN 309, the investigational treatment of hemorrhoids, is a new chemical entity that targets a specific serotonin receptor (5HT2A) thought to be important in the disease, and is formulated as an ointment for intra-anal application. Ventrus completed its acquisition of all rights and title to VEN 309 from the licensor, Sam Amer & Co., last November.
Hemorrhoids, often known as piles, refer to a condition where veins in the lower portion of the rectum or anus become swollen, accompanied by primary symptoms of bleeding, itching and pain. It is estimated that about 10 million to 20 million Americans have hemorrhoids.
Ventrus said it has no immediate plans to continue development of VEN 309, resulting in a reduction in expenses. The first of two pivotal phase III trials of VEN 309 began last August. However, it intends to further analyze the totality of its Phase 3 data.
Meanwhile, the company intends to allocate the current resources towards the planned completion of its VEN 307 (diltiazem cream) development program and the mid-stage study of VEN 308 (topical phenylephrine gel).
VEN 307 is a topical treatment cream for the relief of pain associated with anal fissures, which is also a phase III product. Meanwhile, VEN 308 is a phase II product for the treatment of fecal incontinence associated with ileal pouch anal anastomosis.
Ventrus Biosciences, which went public at $6 per share more than a year back, is focused on developing prescription drugs that address an unmet need in gastrointestinal diseases, specifically, hemorrhoids, anal fissures and fecal incontinence. The company was formerly known as South Island BioSciences Inc.
There are currently no FDA approved prescription drugs for treating hemorrhoids. Some of the treatment options for hemorrhoids include, banding, sclerosing agents and even surgery. Only prescription topical steroid containing products, e.g., oral Daflon, are approved in the EU and Japan.
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by RTT Staff Writer
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