Ventrus BioSciences has announced the results from the Phase IIb study of Iferanserin ointment (VEN 309), its novel investigational drug for the treatment of symptomatic haemorrhoids.
Iferanserin is a new chemical entity (NCE) in late stage development for the topical treatment of haemorrhoids that acts by targeting a specific serotonin receptor (5HT2A). It is applied topically, twice a day.
The double-blind placebo-controlled study randomised 121 patients at five colorectal surgery sites in Germany, and showed that Iferanserin greatly reduced patient-reported severity of daily bleeding beginning on day 1 and itching from day 2 when compared with the placebo. The study also reported sustained effects throughout the 14-day treatment period with a reduction in patient-reported severity of daily pain seen with Iferanserin treatment.
The ongoing Phase III study of Iferanserin has been designed to include around 600 patients in a double-blind three-arm design, with the primary endpoint including cessation of bleeding by day seven to 14 and secondary endpoint involving cessation of itching and pain by day seven to 14.
In the German Phase IIb study, it was 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. The study demonstrated that pain ceased at day seven and did not return by day 14 in 50% of Iferanserin-treated patients compared with 18% in placebo-treated patients.
Ventrus BioSciences chairman and CEO Russell Ellison said the Phase IIb German trial results were significant in defining the targeted patient population and developing meaningful endpoints for their ongoing pivotal Phase III trial for Iferanserin. "The therapeutic benefits observed in the Phase IIb trial suggest a potential role for Iferanserin for the treatment of symptomatic haemorrhoids," he said.
The company plans to report the top line data from its ongoing US Phase III trial of Iferanserin in haemorrhoids in June 2012, and the data from the European Phase III trial of VEN 307 (diltiazem cream) for the treatment of anal fissures in May 2012.