Ventrus Biosciences, Inc. recently announced positive results from its two clinical dermal safety studies and one pharmacokinetic study on its VEN 307 (diltiazem hydrochloride 2% cream). Ventrus is developing VEN 307 for the treatment of anal fissures (AF). The encouraging results from the AF studies positively impacted the company’s stock price.
The company’s dermal safety studies were single-center, randomized, controlled trials which studied the irritation and sensitization potential of the candidate in healthy volunteers. The candidate was generally well tolerated and safe during the study. Results from these studies revealed that the irritation and sensitization potential of VEN 307 was similar to that of placebo and saline. However, VEN 307 proved to be superior to sodium lauryl sulfate on the same count.
Meanwhile, Ventrus’ pharmacokinetic study evaluated VEN 307 in comparison to oral diltiazem in patients suffering from AF. Results revealed that systemic exposure of VEN 307 was around 10% of oral diltiazem, which was consistent with previous data. All pharmacokinetic parameters were also consistent during the study. The study also revealed that VEN 307 maintained a high safety margin. Ventrus stated in its press release that since diltiazem is already approved in oral formulations for the treatment of angina and high blood pressure, VEN 307 qualifies for the U.S. Food and Drug Administration’s 505(b) 2 registration pathway.
Ventrus is currently conducting a second pivotal trial, a phase IIIb study (n=400), on VEN 307. The study is evaluating the efficacy of VEN 307 in reducing severe AF-related pain during defecation when administered three times a day for 28 days. 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 presently carries a Zacks Rank #4 (Sell). Meanwhile, stocks such as Actelion Ltd. , Biogen Idec Inc. (BIIB - Free Report) and Gilead Sciences Inc. (GILD - Free Report) carrying a Zacks Rank #1 (Strong Buy), look more attractive.