Ventrus Biosciences, Inc. focuses on developing and commercializing drugs for gastrointestinal treatments. The company’s lead candidate, VEN 307 (diltiazem hydrochloride 2% cream), is being developed for the treatment of anal fissures (AF).
Earlier in the week Ventrus completed patient enrollment and randomization of a phase III study (n= 434) on VEN 307. This is Ventrus’ second pivotal phase III study on VEN 307. The study, enrolment for which started in Oct 2012, is being conducted at 90 global clinical sites.
The randomized, double-blind, placebo-controlled, parallel-treatment group, multicenter study is evaluating the efficacy of VEN 307 in reducing severe AF-related pain during defecation when administered three times a day for 4 weeks. Ventrus is also evaluating the effects of VEN 307 in bringing down the daily overall AF-related pain. Patient global impression of improvement at the 29th day is also being evaluated.
Results from the study are expected in the first quarter of 2014. Ventrus intends to seek U.S. approval for the candidate in the following quarter (in the event of positive results from the pivotal study).
Ventrus successfully completed the first pivotal phase III study (n=465) on VEN 307 in May last year. Results from the study revealed significant improvements in average worst anal pain associated with or following defecation in patients under VEN 307 compared to placebo. An improvement in overall anal-fissure-related pain was also observed.
We note that diltiazem’s oral formulations are already approved for the treatment of angina and high blood pressure. As a result, VEN 307 is qualified for the FDA's 505(b)2 registration pathway.
Ventrus also has VEN 308 in its pipeline. The candidate is being developed for the treatment of fecal incontinence. We expect investor focus to remain on the company’s pipeline.
Ventrus presently carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Jazz Pharmaceuticals (JAZZ - Free Report) , Actelion Ltd. and Lannett Company, Inc. (LCI - Free Report) . All these stocks carry a Zacks Rank #1 (Strong Buy).