VA 106483 (fedovapagon) meets primary endpoint in EQUINOC Phase III trial for nocturia in men with benign prostatic hyperplasia.- Vantia Therapeutics.

Vantia Therapeutics announced positive top-line data from a pivotal EQUINOC Phase III trial investigating the efficacy and safety of VA 106483 (fedovapagon) in the treatment of nocturia in men with benign prostatic hyperplasia (BPH). The EQUINOC trial is a 432-patient randomised, double-blind, placebo-controlled, multi-centre study conducted in the US.

Patients were randomised to receive fedovapagon or placebo orally each evening over a 12-week treatment period. The trial met both its co-primary endpoints, demonstrating a reduction in nocturnal voids (waking and urinating: and improved quality of life through a patient reported outcome score, NocTIMe. The clinical significance of treatment was supported by statistically significant results for other endpoints including time to first void, nights when patients have 0 or 1 voids and patients who reduce their voids by 50%.

Fedovapagon was generally well tolerated which in combination with the efficacy endpoints, strengthens the potential for it to be a safe and effective treatment for nocturia in men with BPH. A second pivotal 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 US and Europe. Further results and analysis from the EQUINOC trial will be presented at upcoming scientific meetings.