Ventrus Biosciences (NASDAQ: VTUS) is a development stage specialty pharmaceutical company focused on the development of late-stage prescription drugs for gastrointestinal disorders, specifically hemorrhoids, anal fissures and fecal incontinence. There are approximately 12.5 million Americans suffering from hemorrhoids, 7 million from fecal incontinence and over 4 million from anal fissures. The company's product candidate portfolio consists of three late-stage drugs - VEN307 for hypertension and angina, VEN308 for fecal incontinence, and VEN309 for symptomatic hemorrhoids - intended to treat these conditions, for which, to our knowledge, there are no currently FDA-approved prescription drugs in the US.
Ventrus announced that it is now enrolling patients in its VEN309 study, an important phase III clinical trial. The primary objective of the VEN309-Hem-SE3-001 study "is to evaluate the effect of a 5HT2a antagonist ointment (iferanserin) on cessation of bleeding, pain, and itching when administered intra-anally twice daily (BID) for 14 days in subjects with symptomatic internal hemorrhoids."
Key eligibility requirements* for participating in the study include:
- Males or non-pregnant females, ages 18 to 75 years.
- Symptomatic internal hemorrhoids, Grades I-III.
- Bleeding (with itching and/or pain) from hemorrhoids for two consecutive days prior to randomization.
- Complete colon evaluation within three years; no malignancy within five years.
*A full list of patient eligibility criteria is available upon request.
More information available at the VEN309 trial website. Additionally, Dr. Steven D Wexner, Chairman of the Department of Colorectal Surgery at Cleveland Clinic Florida, was featured in a webcast providing additional information about hemorrhoids and the background of the study:
