Ventrus poised for Phase III progress
This article was originally published in Scrip
The US speciality pharmaceutical company Ventrus BioSciences expects to report pivotal data from its two lead products this year.
Top-line data from a Phase III trial of its iferanserin for haemorrhoids are due in June, and will come one month after data are expected for its diltiazem cream formulation for anal fissures.
Iferanserin is a highly selective antagonist of the peripheral 5-HT2A receptors which are involved in clotting and the contraction of arteries and veins, two events believed to be associated with haemorrhoid formation, Ventrus says. By limiting 5-HT2A receptor activity, it hopes the new chemical entity will improve the flow of blood out of the dilated veins that thereby reducing bleeding, itchiness and pain. Its topical application should also reduce exposure to these receptors in the brain.
Phase IIb data for iferanserin have just been published online in Clinical Therapeutics (February print edition) and show that compared with placebo the drug significantly reduced patient-reported bleeding beginning at day one and itching beginning at day two (p<0.05), effects="" which="" were="" sustained="" during="" the="" 121-patient="" two-week="" trial.="" patient-reported="" pain="" scores="" were="" also="" reduced="" and="" adverse="" events="" were="" mild,="" infrequent="" and="" did="" not="" differ="" significantly="" between="" the="" two="">
The paper also includes post hoc analyses using the endpoints that were chosen for the Phase III study now underway, chairman and CEO Dr Russell Ellison said. These are cessation of bleeding by day seven until day 14 (57% vs 20% for iferanserin and placebo respectively in the Phase IIb study), p=0.0001), and cessation of itching and pain by day seven and until day 14 (59% vs 32% for cessation of itching, p=0.034, and 50% vs 18% for pain, p=0.032, in the Phase IIb study).
Few other products are in development for haemorrhoids and the company has done its homework on the potential market for the topical drug. Last year it commissioned a "landmark" survey of consumers and found that nearly 10% of consumers questioned reported having haemorrhoids in the previous year.
85% of patients had either OTC or prescription treatment and 10% had had an invasive procedure at some time, the survey showed, and they reported strong levels of support for a new treatment, even with a $35 co-pay.
Ventrus' other clinical candidate is a topical formulation of phenylephrine (VEN 308) in Phase II for faecal incontinence.