Last week Ventrus Biosciences (NASDAQ: VTUS) reported that the final results from its PIIb study of VEN 309 (Iferanserin ointment) for the treatment of internal hemorrhoid disease (HD) were published. This study was conducted in Europe (Germany) and was randomized, double-blind, t=14-day placebo-controlled trial evaluating the efficacy and tolerability of BID (twice-daily) VEN 309 for the cessation of bleeding and other symptoms associated with Hemorrhoids.
The study hit its primary endpoint demonstrating efficacy and safety. The primary efficacy endpoints was a severity scores for bleeding on days 7 & 14. Secondary efficacy endpoints were itching, pain and other related symptoms also on day 7 & 14. The study was well powered at n= 111 patients split between control (placebo) and active VEN 309 groups.
VEN 309 was associated with a statisically significant reduction in daily bleeding & itching on both days seven and 14 (bleeding, p<0.0001 and p=0.0075, respectively; itching, p=0.0008 and p=0.027, respectively). In terms of pain relief the data showed a favorable trend but was not statisically significant. Given that this is a Phase II trial and not a Phase III trial we are not concerned, a larger Phase III (P3 n=600) should add enough pwer to see a significant result.
VEN 309 is on track to be the first new treatment (FDA Approved) for hemorrhoids. VEN 309 is in a Phase 3 trial now with top-line results expected this spring to summer.