Novo Nordisk-backed Vantia announces Phase III success

UK-based Vantia Therapeutics, which is backed by a Novo Nordisk-owned fund and other investors, has announced positive top-line data from a pivotal Phase III trial investigating fedovapagon (VA106483) in the treatment of nocturia in men with benign prostatic hyperplasia (BPH).

The EQUINOC trial is a 432-patient randomized, double-blind, placebo-controlled, multi-center study conducted in the USA over a 12-week treatment period. The study met both its co-primary endpoints, demonstrating a reduction in nocturnal voids and improved quality of life through a patient reported outcome score.

A second Phase III study based on the same endpoints and population will now be conducted with the goal of providing further data required to support regulatory filings for marketing approval in the USA and Europe.