PIPELINE

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VT-1161

Fungal infections represent a significant underserved medical problem for millions of people worldwide. Our lead drug candidate, VT-1161, was designed using advanced medicinal chemistry to have greater selectivity, fewer side effects and improved potency as compared to currently available antifungal agents.


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VT-1161 is an orally available inhibitor of fungal CYP51 that has shown high potency and selectivity.

Because the molecule VT-1161 is highly selective for fungal CYP51, it may avoid the side effects that limit the use of current antifungals, including fluconazole and terbinafine, which are often prescribed for acute episodes of vulvovaginal candidiasis and onychomycosis, respectively. In addition, due to the high potency and therapeutic index of VT-1161, we believe it may play a pivotal role in the treatment of additional fungal infections.


VT-1161 for Recurrent Vulvovaginal Candidiasis (RVVC)

VT-1161 is currently in three Phase 3 clinical studies to evaluate its safety and efficacy, and its ability to treat acute infections with RVVC, a common mucosal infection more commonly known as chronic yeast infection, for which there are no approved therapy in the United States. 


A Study of Oral VT-1161 for the Treatment of Acute Vaginal Candidiasis (Yeast Infection) in Patients With Recurrent Vaginal Candidiasis (ultraVIOLET)
A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of VT-1161 Oral Capsules Versus Fluconazole and Placebo in the Treatment of Acute Vulvovaginal Candidiasis Episodes in Subjects With Recurrent Vulvovaginal Candidiasis (ClinicalTrials.gov identifier: NCT02267382)

A Study of Oral VT-1161 for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) (VIOLET)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VT-1161 Oral Capsules in the Treatment of Subjects With Recurrent Vulvovaginal Candidiasis (ClinicalTrials.gov Identifier: NCT03562156)

A Study of Oral VT-1161 for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) (VIOLET)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VT-1161 Oral Capsules in the Treatment of Subjects With Recurrent Vulvovaginal Candidiasis (ClinicalTrials.gov Identifier: NCT03561701)


VT-1161 for Onychomycosis

VT-1161 has also been studied as an oral therapy for the treatment of onychomycosis, a common fungal infection of the nail for which current therapies are not optimal in respect to safety, tolerability, efficacy and duration of response.

“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)

We successfully completed the RENOVATE study, a Phase 2b study in onychomycosis of the toenail in December 2016, which met its primary endpoint of complete cure rates at 48 weeks.

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


VT-1598 for a range of invasive fungal infections

Mycovia is developing oral drug candidate VT-1598 to combat serious fungal pathogens and is in Phase 1 development. VT-1598 has shown in vitro and in vivo activity against Cryptococcus neoformans, Coccidioides and Candida auris, each of which pose a growing global threat due to underlying multi-drug resistance.

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

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