Title

A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)
A Phase 2A, Randomized, Double-Blind, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets Compared to Fluconazole in the Treatment of Patients With Moderate to Severe Acute Vulvovaginal Candidiasis
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Study Participants

    55
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast infection). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this results in many of the side effects associated with the azole antifungals. The safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. VT-1161 has been design to be safer and more active against the fungal species typically responsible for vaginal yeast infections (i.e. vulvovaginal candidiasis).
Study Started
Aug 31
2013
Primary Completion
Dec 31
2014
Study Completion
Dec 31
2014
Results Posted
Jul 06
2018
Last Update
Aug 01
2018

Drug VT-1161

Drug Fluconazole

VT-1161 300mg QD Experimental

VT-1161 600mg QD Experimental

VT-1161 600mg BID Experimental

Fluconazole 150mg Active Comparator

Criteria

Key Inclusion Criteria:

Females ≥18 and <65 years
Clinical diagnosis of symptomatic acute VVC
Positive KOH .At least one vulvovaginal sign (vulvovaginal erythema, edema, or excoriation).
At least one vulvovaginal symptom (vulvovaginal itching, burning, or irritation)
A minimum composite vulvovaginal signs and symptoms score of ≥6
must be be able to swallow capsules

Exclusion Criteria:

Evidence of major organ system disease
History of cervical cancer
History of diabetes mellitus
Pregnant
Recent use of systemic antifungal drugs or systemic antimicrobial therapy for any reason
Recent use of drugs to treat vaginal infections
Recent use of immunosuppressive therapies

Summary

VT-1161 300mg QD

VT-1161 600mg QD

VT-1161 600mg BID

Fluconazole 150mg

All Events

Event Type Organ System Event Term VT-1161 300mg QD VT-1161 600mg QD VT-1161 600mg BID Fluconazole 150mg

Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population

For this trial, therapeutic cure was defined as mycological AND clinical cure. Mycological cure was defined as a negative fungal culture for Candida species. Clinical cure was defined as all of the following: complete resolution of signs and symptoms pertaining to vulvovaginal candidiasis; any new sign or symptom observed at 28 days determined by investigator to not be related to vulvovaginal candidiasis; no use of any other antifungal drug therapy for treatment of vulvovaginal irritation and/or pruritus by subject.

VT-1161 300mg QD

VT-1161 600mg QD

VT-1161 600mg BID

Fluconazole 150mg

Total

55
Participants

Age, Continuous

32.7
years (Mean)
Standard Deviation: 10.4

Sex: Female, Male

Overall Study

VT-1161 300mg QD

VT-1161 600mg QD

VT-1161 600mg BID

Fluconazole 150mg