Iferanserin ointment (VEN 309)
For the topical treatment of hemorrhoids.
Hemorrhoids, which are characterized by the inflammation and swelling of veins around the anus or lower rectum, can cause bleeding, itching, pain and difficulty defecating. As reported by the National Institute of Diabetes and Digestive Kidney Diseases, hemorrhoids affect nearly half of all men and women by age 50. Despite such a high prevalence, we are not aware of any FDA approved prescription drugs for the treatment of hemorrhoids. As a result, we have developed iferanserin ointment (VEN 309), which we believe to be more efficacious and/or less invasive than conventional hemorrhoid therapies. Iferanserin has selective, antagonistic activity against peripheral 5-HT2 receptors involved in clotting and the contraction of arteries and veins, two events believed to be associated with hemorrhoid formation. By limiting 5-HT2 receptor activity, VEN 309 improves the flow of blood out of the dilated veins that comprise the hemorrhoid, thereby reducing bleeding, itchiness and pain. The potential for side effects is limited by the topical application of the drug. In multiple clinical trials, iferanserin ointment significantly reduced bleeding, pain and itchiness compared to placebo with minimal adverse effects.

Diltiazem cream (VEN 307)
A topical treatment for the relief of pain associated with anal fissures.
Anal fissures, or small tears or cuts in the skin that lines the anus, are quite common, affecting nearly 2% of the U.S. adult population. They can be extremely painful, cause bleeding and often require surgery, which itself can have unsatisfactory outcomes. At present, we are not aware of any FDA approved drugs for the treatment of anal fissures. However, diltiazem cream is currently used as the preferred treatment by many gastroenterologists across the U.S. in a version that must be specially mixed for each patient in the pharmacy. We expect to capture immediate market share if VEN 307 is approved due to its efficacy and ease of prescription, with no need for custom mixing necessary at the pharmacy. When applied topically for the treatment of anal fissures, diltiazem, a drug that has been used for decades for hypertension and angina, dilates the blood vessels supplying the region, reduces anal sphincter tone, and thereby substantially decreases pain. In multiple clinical trials conducted against placebo or another commonly used (but not FDA approved) treatment, topical nitroglycerine, diltiazem cream significantly reduced the pain associated with anal fissures. Applied topically in our proprietary formulation, diltiazem is only minimally absorbed, at one-tenth the amount of the lowest dose used for cardiovascular treatment. VEN 307 has progressed through early-stage clinical trials, toxicology studies and manufacturing up to the end of Phase II. We have licensed the exclusive North American rights to VEN 307 for the topical treatment of anal fissures from S.L.A. Pharma AG, who is conducting a development program in Europe.

Phenylephrine gel (VEN 308)
For the treatment of fecal incontinence associated with ileal pouch anal anastomosis, or IPAA, an FDA orphan indication.
Ileal pouch anal anastomosis is a surgical procedure used as part of a colectomy, which is a treatment for patients with ulcerative colitis. Fecal incontinence resulting from dysfunctional sphincter tone is a common consequence of this procedure. Currently, there are few options, including, to our knowledge, no FDA approved drugs, available to treat this problem. Therefore, we have developed VEN 308, a phenylephrine gel we believe to have significant advantages over the limited treatment options currently available. Phenylephrine has been used by millions of patients as a common ingredient of cough and cold medications. Applied topically, phenylephrine gel increases anal sphincter tone, thereby improving fecal incontinence in patients where sphincter tone is the major cause of their symptoms (such as post IPAA surgery). In multiple clinical trials with patients suffering from IPAA-associated fecal incontinence, topical phenylephrine significantly (and in some patients, dramatically) improved patient bowel control. In clinical trials with other forms of incontinence, improvements were also observed following application of topical phenylephrine, depending on the cause of the incontinence. We have licensed the exclusive North American rights for VEN 308 as a topical treatment for fecal incontinence from S.L.A Pharma, who expects to conduct a European development program.