Mycovia Pharmaceuticals Announces Peer-Reviewed Publication of Positive Study Results of Oteseconazole for the Treatment of Acute Vulvovaginal Candidiasis
DURHAM, N.C.: Mycovia Pharmaceuticals, Inc.has announced the publication of results from a Phase 2 clinical study of its oral antifungal product candidate oteseconazole (VT-1161) for the treatment of acute vulvovaginal candidiasis (VVC). The results demonstrated that oteseconazole was safe and well tolerated in women with moderate to severe acute VVC, and more women experienced therapeutic cure in the treatment arms containing oteseconazole versus those treated with fluconazole, the current standard of care for the disease that affects 75 percent of women in their lifetime.i The study, “A Randomized Phase 2 Study of VT-1161 for the Treatment of Acute Vulvovaginal Candidiasis,” was peer-reviewed and published in Clinical Infectious Diseases, a journal of the Infectious Diseases Society of America.
“The publication of these study results reinforces oteseconazole’s potential as a much-needed treatment option for the millions of women who experience the painful and anxiety-ridden effects of yeast infections, whether acute or recurrent,” said Stephen Brand, PhD, Chief Development Officer at Mycovia. “Taken together with our ongoing Phase 3 clinical trial programs, with topline results due later this year, we are eager to provide women and their health care providers with a potential novel therapy for a disease that has lacked meaningful innovation for three decades.”
Brand continued, “For years, fluconazole has been the go-to therapy to treat VVC. Oteseconazole was designed to selectively inhibit fungal CYP51, an enzyme essential for fungal growth, thus avoiding off-target toxicities, drug-drug interactions and pregnancy concerns often associated with the azole drug class. In this study and others, oteseconazole has shown to be safe, and more potent than fluconazole against the Candida species that cause VVC.”
The Phase 2 study evaluated the efficacy and safety of oteseconazole versus fluconazole in women who experienced a moderate-to-severe acute episode of VVC (n=55). Key findings highlighted in the publication include:
- 79.3% of women in the combined oteseconazole groups achieved therapeutic cure compared with 62.5% of those in the fluconazole group
- At three and six months, no women in the oteseconazole groups had evidence of mycological recurrence compared with 28.5% and 46.1% of women in the fluconazole group, respectively
- No serious adverse events or treatment-emergent adverse events leading to discontinuation were reported
Mycovia has three ongoing Phase 3 trials evaluating the clinical effectiveness of oteseconazole in women with RVVC over 48 Weeks – two global trials (VIOLET) and one U.S. trial (ultraVIOLET). The trials, which are being conducted in 11 countries, completed enrollment in December 2019 with more than 870 patients. Subjects remaining free of infection at Week 48 may participate in an extension study and be followed for a further 48 weeks. Topline data from the VIOLET and ultraVIOLET trials are expected later this year, with an anticipated U.S. launch of oteseconazole in 2021.
The publication can be accessed on the Clinical Infectious Diseases website: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1204/5895051.