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WIKI ANALYSISVentrus 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 Ventrus lead product, Inferanserin (VEN 309) is a new chemical entity, or NCE, for the topical treatment of hemorrhoids, which targets a specific serotonin receptor (5HT2A) thought to be important in the disease.
Ventrus is a development stage specialty pharmaceutical company focused on the development of late-stage (PH II and PH III) prescription drugs for gastrointestinal disorders, specifically, hemorrhoids, anal fissures and fecal incontinence.
The Company believes that hemorrhoids, anal fissures and fecal incontinence each represent a significant unmet medical need. While there are approximately 12.5 million Americans suffering from hemorrhoids, 7 million from fecal incontinence and over 4 million from anal fissures, we are not aware of any U.S. Food and Drug Administration, or FDA, approved prescription treatments for these conditions
The Ventrus product candidate portfolio consists of three late-stage drugs intended to treat these conditions, for which, to our knowledge, there are no currently approved prescription products in the US[1]:
- VEN 309, iferanserin cream for the treatment of hemorrhoids, a new chemical entity, or NCE, ready to enter PH III studies;
- VEN 307,Diltiazem cream a commonly used drug used orally for hypertension and angina, formulated topically for the treatment of anal fissures, ready to enter Phase III studies;
- VEB 308, Phenylephrine gel a common ingredient in cough and cold medicines, formulated topically for the treatment of fecal incontinence ; ready to enter PH IIB studies.
About Hemorrhoids
Hemorrhoids are a common anal disorder characterized by bleeding, itching, pain, swelling, tenderness, and difficulty with defecating. Hemorrhoids are pathologic dilatations of the normal vascular beds in the anal and rectal regions. Although the mechanism for hemorrhoid formation is unclear, progressive occlusion of venous exit vessels (as can occur in straining during defecation, heavy lifting, and pregnancy) is thought to produce stretching of vessels and vascular stasis. As hemorrhoids worsen, the trapped blood forms piles (protruding skin folds filled with static and thrombosed blood) initially above the line that marks the end of the rectum and the beginning of the anal canal (internal hemorrhoids) and then below the line (external hemorrhoids). We are not aware of any prescription products currently approved for the treatment of hemorrhoids. Products currently used for hemorrhoids do not affect the underlying causes and provide only symptomatic relief. Patients with persistent symptoms, especially bleeding, progress to invasive procedures, such as rubber band ligation, which involves banding the internal hemorrhoid for 4 to 7 days.
About Anal Fissure
An anal fissure is a crack in the skin of the anal canal. Typical symptoms are severe pain and bleeding with or after bowel movements. Hypertonia, which is an increase in tightness of muscle tone of the internal anal sphincter, contributes to chronic anal fissures. There are no approved pharmacologic products for the treatment of anal fissure of which we are aware. For severe pain, surgery often is performed to reduce the internal anal sphincter by either manual dilatation or lateral sphincterotomy. Both procedures successfully promote healing of anal fissure but have been associated with fecal incontinence.
About Fecal Incontinence
Continence of solid stool is maintained by the internal and external anal sphincters. Damage to the anal sphincters can disrupt continence. Specific causes of fecal incontinence include obstetrical injury; prior anorectal surgery, such as ileal pouch anal anastomosis; fecal impaction; sphincter trauma; cancer; and neurologic disease. To our knowledge there are no approved products for the treatment of fecal incontinence. The most common surgical procedure for fecal incontinence is sphincteroplasty for patients with physical injury to the anal sphincter, but success rates for this type of surgery are low and most of the benefits decrease with time.
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