Ventrus reports Iferanserin Phase 2b trial data

Iferanserin is a new chemical entity (NCE), that acts by targeting a specific serotonin receptor (5HT2A) for the topical treatment of hemorrhoids.

The Phase 2b trial is a double-blind placebo-controlled study that randomised 121 patients with Iferanserin, and showed that the product significantly minimised patient-reported severity of daily bleeding beginning at day 1 and itching beginning at day 2 when compared to placebo.

The trial also showed that in 50% of iferanserin-treated patients, pain ceased at day 7 and did not return by day 14, compared to 18% in placebo-treated patients.

Ventrus BioSciences chairman and CEO Russell Ellison said the therapeutic benefits observed in the Phase 2b trial suggest a potential role of Iferanserin for treating symptomatic hemorrhoids.

"The findings of this Phase 2b German trial were significant in defining the targeted patient population and developing meaningful endpoints for our ongoing pivotal Phase 3 trial for iferanserin,” Ellison added.

Earlier German Phase 2b study determined that 57% of iferanserin-treated patients had cessation of bleeding versus only 20% of placebo-controlled patients, and also reported that 59% of Iferanserin-treated patients versus 32% of placebo-controlled patients had cessation of itching.