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Clinical Trials

Clinical Trials: VT-1161

VT-1161 is an oral therapy that is being developed for the treatment of onychomycosis, a very common fungal infection of the nail for which current therapies are not optimal with respect to safety, tolerability, efficacy and duration of response. We are also developing VT-1161 for recurrent vulvovaginal candidiasis, or RVVC, a very common condition for which we believe there are no approved therapies in the United States.

We successfully completed a Phase 2b study in onychomycosis of the toenail (the RENOVATE study) in December 2016 with the study meeting its primary endpoint of complete cure rates at 48 weeks. We also successfully completed a Phase 2b study in RVVC (the REVIVE study) in December 2016 with the study meeting its primary endpoint of proportion of subjects with one or more culture-verified AVVC episodes through 48 weeks.

VT-1161 has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for the treatment of recurrent vulvovaginal candidiasis by the U.S. Food and Drug Administration.

Ongoing Clinical Studies of VT-1161

  • “RENOVATE” Study (REstoring Nail: An Oral VT-1161 Tablet Evaluation): A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Distal Lateral Subungual Onychomycosis of the Toenail (ClinicalTrials.gov identifier: NCT02267356)
  • “REVIVE” Study (REcurrent Vulvovaginal Candidiasis Inhibition: An Oral VT-1161 Tablet Evaluation): A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Recurrent Vulvovaginal Candidiasis (ClinicalTrials.gov identifier: NCT02267382)

These clinical trials were conducted at multiple locations throughout the United States. To find out more about our clinical trials for VT-1161, click here.

Clinical Trials: VT-1129

VT-1129 is an oral therapy that is being developed for the treatment of cryptococcal meningitis, a life-threatening fungal infection of the brain and the spinal cord that occurs most frequently in patients with HIV infection, transplant recipients and oncology patients. Without treatment, the disease is almost always fatal.

VT-1129 has received orphan drug and Fast Track designations for the treatment of cryptococcal meningitis and has been designated a Qualified Infectious Disease Product (QIDP) by the U.S. Fod and Drug Administration.

Ongoing Clinical Studies of VT-1129

  • A Phase 1 single-ascending dose study of VT-1129 in healthy volunteers has been initiated.