RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Viamet Pharmaceuticals, Inc. today announced that the company will present at the 25th European Academy of Dermatology and Venereology (EADV) Congress, September 28 - October 2, 2016, at the Austria Center Vienna in Vienna, Austria. The EADV is a non-profit association dedicated to advancing excellence in clinical care, research, education and training in the fields of dermatology and venereology.
Dr. Amir Tavakkol, Ph.D., the company’s Chief Development Officer, will provide an oral presentation at the meeting titled, “Oral VT-1161, a Novel and Selective Fungal CYP51 Inhibitor, Shows Significant Clinical Improvement, High Rate of Mycologic Cure, and Excellent Tolerability in Patients with Moderate-to-Severe Toenail Onychomycosis in a Randomized, Double-Blind, Placebo-Controlled Trial”. The presentation will take place Thursday, September 29, at 3:40 p.m. CET.
Dr. Tavakkol’s presentation will highlight the impressive efficacy and safety results from a planned interim analysis of the company’s RENOVATE study. RENOVATE is a randomized, double-blind, placebo-controlled Phase 2b study of VT-1161 in approximately 260 patients with moderate-to-severe onychomycosis of the toenail. The planned interim analysis was conducted when approximately 100 patients had completed the first 24 weeks of the trial. At baseline, mean involvement of the large toenail was 46% and the average number of toenails affected was 4.7 across the trial arms. In the intent-to-treat interim analysis, there was a 48% average reduction in the percentage of nail involvement at week 24 across the VT-1161 arms, as compared to a 6% reduction in the placebo arm. The median reduction in percentage nail involvement in the VT-1161 arms was as high as 67% at week 24. In addition, the percentage of patients with ≤10% (clear or almost clear) nail involvement at week 24 was as high as 35% across the VT-1161 arms compared to 0% in the placebo arm. Safety data from the interim analysis population through the week 24 visit demonstrated that VT-1161 was well-tolerated with a favorable safety profile. In particular, there was no evidence of an adverse effect on liver function.
VT-1161, which is also being studied in a Phase 2b clinical trial for recurrent vulvovaginal candidiasis (RVVC), is part of a robust portfolio of antifungal compounds under development by Viamet. Onychomycosis is a very common fungal infection of the nail for which current oral therapies are suboptimal with respect to both efficacy and safety, and RVVC is a common mucosal infection in women for which there are currently no approved therapies in the United States.
“VT-1161 is a novel, potent and highly selective oral inhibitor of fungal CYP51 that has demonstrated broad-spectrum activity against pathogenic fungi, including species that cause onychomycosis,” said Dr. Tavakkol. “We discovered VT-1161 using Viamet’s proprietary metalloenzyme chemistry and biology technology, which enables us to design compounds with improved efficacy, safety and pharmacokinetic properties. Given the preclinical and clinical data to date, we believe that VT-1161 may display greater efficacy and safety compared to the current standard of care for onychomycosis, a condition that afflicts approximately 32 million individuals in the United States. We look forward to receiving final results from the RENOVATE study later this year.”
VT-1161 is a potent and selective, orally-administered inhibitor of fungal CYP51 currently in Phase 2b clinical trials for the treatment of onychomycosis, the RENOVATE study, and RVVC, the REVIVE study. 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 pre-clinical profile of VT-1161, the Company 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.
About the RENOVATE Study
RENOVATE (REstoring Nail; an Oral VT-1161 Tablet Evaluation), is an ongoing randomized, double-blind, placebo-controlled Phase 2b clinical trial in patients with toenail onychomycosis. The study will evaluate two dose levels of VT-1161 administered once weekly for either 10 or 22 weeks following an initial two-week, once-daily loading dose period. The primary endpoint will be the percentage of patients achieving complete cure of the target nail at week 48 of the study. Viamet previously reported robust antifungal activity and a very favorable safety profile for VT-1161 in a Phase 2a proof-of-concept study in the treatment of tinea pedis, or athlete’s foot, which is caused by the same pathogens as onychomycosis.
Onychomycosis, a fungal infection that primarily involves the nail bed and surrounding tissues, is an extremely common infection, affecting approximately 32 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.
About Viamet (www.viamet.com)
Viamet discovers and develops breakthrough therapies based on our leadership in metalloenzyme chemistry and biology. Our clinical portfolio includes novel agents to treat both chronic and life threatening fungal infections. We also leverage our metalloenzyme expertise in other therapeutic areas including oncology and orphan diseases. Focusing on the needs of patients and clinicians, we design our drug candidates to achieve superior safety and efficacy profiles compared to currently marketed drugs.
This press release includes forward-looking statements. Actual results may vary materially from these statements. There are many important risks affecting Viamet’s business, including that clinical trials may not be commenced, or if commenced, may not be successful, regulatory approvals may not be obtained and approved products, if any, may not achieve commercial success. The Viamet group of companies includes Viamet Pharmaceuticals Holdings, LLC and its operating subsidiaries, Viamet Pharmaceuticals, Inc., VPS-2, Inc. and VPS-3, Inc. The Viamet group of companies is based in the Research Triangle Park region of North Carolina, USA.