Phase III Clinical Trials Nearing for Ventrus Biosciences, Inc. (VTUS)

By @ibtimes on

While many biotechnology firms go for the “home run” by spending millions searching for viable solutions to ever-mutating strains of life-threatening diseases, others have taken the approach of focusing on smaller disorders that still have a great area of unmet need. There is certainly some prestige that attracts biotechnology investors as everyone is searching for the next great Lipitor-type drug or a viable therapy to effectively treat cancers, but for developmental biotechs, it is not always a great fit as the road less traveled is often where more success can be found.

New York-based Ventus Biosciences, Inc., a specialty pharmaceutical company with three compounds in Phase II clinical trials, focuses on the development and commercialization of late-stage prescription drugs for gastrointestinal disorders; primarily hemorrhoids, anal fissures, and fecal incontinence. The Ventrus path is becoming paved as Phase III clinical trials are approaching and clinical development staffing has recently been completed.

Ventrus is uniquely positioned as an industry leader as there are currently no FDA-approved prescription drugs for the treatment of hemorrhoids, a disorder which affects over 12 million Americans each year. The Company is in late-stage phase II human trials with VEN309 (iferanserin ointment), a topical solution, which data from multiple clinical trials suggest it is more efficacious and/or less invasive than conventional hemorrhoid therapies. The Ventrus approach is novel as Iferanserin has selective, antagonistic activity against peripheral 5-HT2A receptors involved in clotting and the contraction of arteries and veins; two events believed to be associated with hemorrhoid formation. VEN309 limits 5-HT2A receptor activity and improves the flow of blood out of the dilated veins that comprise the hemorrhoid, thereby reducing bleeding, itchiness and pain. Minimal side effects have been reported throughout the course of research.

Also nearing completion of Phase II clinicals is VEN307 (Diltiazem cream), a topical treatment for the relief of pain associated with anal fissures. Anal fissures, small tears or cuts in the specialized tissue that lines the anus or anal canal (anoderm), can be extremely painful and affect approximately 5 million adults each year and are responsible for up to 15 percent of appointments to recta/colorectal and colonic surgeons, often resulting in surgery. Much like hemorrhoid therapies, there are no FDA-approved prescribed drugs on the market to treat anal fissures; although diltiazem cream is already a treatment of choice amongst many gastroenterologists across the U.S., but the formulation must be specially prepared for each patient by a pharmacy at this point. Ventrus’ proprietary formulation of VEN307 is based upon diltiazem, a drug which has been used for years for hypertension and angina. Data collected from multiple human trials has shown when applied topically, VEN307 has substantially reduced pain in response to the solution; causing a dilation of the blood vessels supplying the area and reduction in sphincter tone; outperforming both the placebo and commonly used therapies today.

Rounding out the Ventrus pipeline is VEN308 (Phenylephrine gel), which is being developed as a treatment for fecal incontinence associated with ileal pouch anal anastomosis, or IPAA, an FDA orphan indication. Fecal incontinence often results from a dysfunctional sphincter tone as a result of IPAA, a surgical procedure used as part of a colectomy. In this case, not only are there no FDA approved drugs, but very few therapies in general. Ventrus once again found a novel use for an existing compound, as phenylephrine is a common ingredient in cold and cough medications, but when applied topically, phenylephrine gel increases sphincter tone and assists in controlling fecal incontinence. Clinical trials have consistently shown improvement in a patient’s bowel control, in some cases dramatic improvements were observed. Ventrus holds the exclusive North American rights to both VEN308 and VEN307 through licensing agreements with S.L.A. Pharma, who is also planning to conduct European development programs.

Ventrus expects to immediately generate significant revenues if/when their compounds are FDA approved as their chosen area of focus has extremely limited competition and millions of patients in need which should lead to rapid market share capture. With Rodman and Renshaw recently rating Ventrus as outperform and placing a $12 price target on the share price, this little developmental biotech may be starting to garner the attention of the not only institutions, but the mainstream investment community.

More information on Ventrus Biosciences and its pipeline of late-stage drugs can be found on the Company’s website at www.ventrusbio.com

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