Mycobactovir for the Treatment of Vulvovaginal Candidiasis: Results from A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial (ex-US)
TGV-Laboratories to Present Results from Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial. Research Presented in a Poster Session at American Society for Microbiology (ASM) Microbe 2018
NEW YORK, NY, June 10, 2018 — TGV-Therapeutics (TGV), a privately held company and our goal is to bring the therapy of invasive fungal infections to a principally new level of the efficacy. The study, coordinated by Drs. V. Tetz and G. Tetz, was presented by Dr. G. Tetz in a poster session at American Society for Microbiology (ASM) Microbe 2018, June 7–11, 2018, in Atlanta
Background: Vulvovaginal candidiasis (VVC) is a common vaginal infection affecting about 75% of women during their lifetime. The primary causative agents of VVC are Candida albicans and C. glabrata, which has emerged as the most common non-albicans Candida species. Approximately 3-12% of Candida spp. are resistant to azoles, which can result in treatment failure, recurrent VVC, and increased transmission of resistant strains. TGV-MYC is a first-in-class, orally available, small molecule inhibitor of fungal nucleic acid synthesis and chitin synthase. In vitro, TGV-MYC exerted a significant fungicidal effect against azole- and echinocandin-resistant Candida spp. isolates. Methods: A multicenter, randomized, double-blind, placebo-controlled trial on the efficacy and safety of TGV-MYC in patients with acute exacerbation of chronic VVC was conducted in Europe. Subjects received TGV-MYC capsules (1200 mg BID) or placebo for 6 days (p<0.001). The primary endpoint was clinical cure (based on gynecological examination [itching, burning, dysuria, and discharge]) and mycological response at day 7. The patients had follow-up visits at 7 days after the last therapeutic dose (14th day). Results: There was a statistically significant difference between the TGV-MYC and placebo arms to both clinical and mycological cure rates. The clinical cure rates were 92.6% (88/95) at day 7 and 95.8% (91/95) at day 14 in the TGV-MYC group, and were 36.2% (34/94) at day 7 and 71.3% (67/94) at day 14 in the placebo group. The mycological cure rates in the TGV-MYC and placebo groups were 83.2% (79/95) and 58.5% (55/94), respectively, at follow-up on day 7 (P <0.001 for all). No serious adverse events were associated with TGV-MYC treatment.Conclusions: This study demonstrates that TGV-MYC (1200 mg orally BID for 6 days) is highly efficacious treatment for VVC. TGV-MYC was well tolerated and had a benign safety profile with no serious adverse events detected. Overall, this drug has a promising therapeutic potential, especially in cases caused by azole- and echinocandin-resistant strains.
- Data indicates that the antibiotic MYC-053; developed by TGV Therapeutics, has proven effective against the deadly fungal infection Candida auris (C.auris) candidemia.
- Initial testing by TGV was so promising the NIH decided to expand research into MYC-053.
- C.auris is a pathogenic fungus that has been known to spread in healthcare facilities. C.auris can infect wounds, the bloodstream, and the urinary tract.
- The pathogen is extremely dangerous because itis resistant to many existing antifungal drugs.
- MYC-053 is TGV’s lead product candidate, and itis described as a “novel antifungal agent that is structurally distinct fromthe three main classes of antifungal antibiotics.”.
NEW YORK, NY / ACCESSWIRE / March 7, 2018 / TGV Therapeutics, the pharmaceutical company developing first-in-class drugs for fighting antibiotic-resistant infections, announced today it is working with the National Institutes of Health to expand its research on a drug that shows promise against new fungal superbugs.