Ventrus Biosciences has reported positive data from a Phase 3 study treating patients suffering from anal fissures with its diltiazem hydrochloride cream (VEN 307).
Diltiazem hydrochloride is a calcium-channel blocker that has been shown to normalise internal anal sphincter pressure and reduce anal maximal resting pressure and vasodilator activity, thereby decreasing the pain associated with anal fissures.
The double-blind, placebo-controlled Phase 3 study was conducted across 31 centres in Europe by S.L.A. Pharma, the product candidate’s licensor.
In the trial, 465 subjects were randomised 1:1:1 to three treatment arms, 4% or 2% diltiazem hydrochloride cream or placebo applied topically three times daily (TID) for eight weeks, followed by a four week blinded observation period.
Both 4% and 2% diltiazem treatment arms demonstrated improvements in the primary endpoint of average of worst anal pain associated with or following defecation and in the secondary endpoints of overall anal-fissure-related pain and anal fissure healing compared to placebo.
Ventrus Biosciences chairman and chief executive officer Russell Ellison said that the study’s outcome exceeded the company’s expectations, demonstrating an improvement in all three measures of efficacy: pain on defecation, average daily pain and healing.
"We look forward to next steps in the clinical and regulatory process and to bringing VEN 307, as expeditiously as possible, to those suffering from anal fissures," Ellison added.
"These results come as Ventrus prepares for near-term pivotal data from a second pipeline product, VEN 309, in hemorrhoidal disease."
Following the positive outcomes from the study, the company is planning to request a meeting with the US Food and Drug Administration (FDA) to discuss the Phase 3 diltiazem study, as well as steps to move forward towards a New Drug Application (NDA).
Ventrus intends to commence a second pivotal Phase 3 study of VEN 307 in anal fissures in the second half of 2012.