Viamet Pharmaceuticals, Inc. today announced that Chief Development Officer, Amir Tavakkol, Ph.D., Dip. Bacteriol, will present data from the Company’s VT-1161 therapeutic program in the treatment of onychomycosis, or fungal nail infection, at the 4th International Summit on Nail Diseases, being held June 23 to 25 in Athens, Greece. The poster will include results of Viamet’s successful Phase 2b RENOVATE study for VT-1161, the Company’s novel inhibitor of fungal CYP51, in the treatment of moderate-to-severe distal-lateral subungual onychomycosis.
Additional Details of the VT-1161 program presentation are as follows:
Title: Efficacy and Safety of VT-1161 in a Randomized, Double-Blinded, Placebo-Controlled Phase 2 Study of Four Oral Dosing Regimens in the Treatment of Patients with Moderate-to-Severe Distal-Lateral Subungual Onychomycosis (DLSO)
Date/Time: Saturday, June 24, 11:45 AM – 12:15 PM (GMT+3) and 3:15 – 4:00 PM (GMT+3)
Sunday, June 25, 11:30 AM – 12:00 PM (GMT+3)
Location: Poster Exhibit Hall
VT-1161 is a potent and selective, orally-administered inhibitor of fungal CYP51 which recently successfully completed Phase 2b clinical trials for the treatment of onychomycosis, or fungal nail infection, and recurrent vulvovaginal candidiasis (RVVC), a common and difficult to treat infection in women. VT-1161 blocks the production of ergosterol, an essential component of the fungal cell membrane. In preclinical studies, VT-1161 has demonstrated broad-spectrum activity against both dermatophytes and Candida species, including those species that cause onychomycosis and RVVC. Given the clinical and preclinical profile of VT-1161, Viamet believes that it may avoid the side effects that limit the use of current oral antifungal therapies, such as liver toxicity and drug-drug interactions. The U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to VT-1161 for the treatment of RVVC.
About the RENOVATE Study
RENOVATE was a randomized, double-blind, placebo-controlled, clinical trial of VT-1161 in patients with distal-lateral subungual onychomycosis (DLSO) of the large toenail. The trial evaluated two dose levels of VT-1161 (300 mg and 600 mg) administered once weekly for either 10 or 22 weeks following an initial two-week, once-daily loading dose period. The trial enrolled 259 patients with 25-75% DLSO involvement of the large toenail at baseline at 32 sites throughout the United States. At baseline, mean DLSO involvement of the large toenail was 46% and the average number of toenails affected was 4.6 across the trial arms. The primary efficacy endpoint was complete cure of the target large toenail at week 48, a composite endpoint that requires both complete clinical cure and negative mycology. Patients were also evaluated for complete cure at week 60.
Onychomycosis, a fungal infection that primarily involves the nail, nail bed and surrounding tissues, is an extremely common infection, affecting approximately 35 million individuals in the United States. The infection is characterized by deformation, discoloration, thickening and splitting of the nail, as well as separation of the nail plate from the nail bed. Damage to the nail can also result in pain when walking, limiting ambulation. The unsightly appearance of the infected nail and the perception that there is an active and contagious infection is a significant concern for many patients. Onychomycosis can also be a significant medical issue for diabetics or other patients with compromised immune systems or poor circulation of the lower extremities. In these patients, the infected nail can serve as an entry point for bacterial infection, which can in turn lead to serious complications such as tissue necrosis and amputation.