DURHAM – Mycovia Pharmaceuticals, a developer of drugs in women’s health, has initiated “extension studies” as part of its ongoing Phase 3 global clinical trial of its lead drug candidate for treating recurrent yeast infections in women.
The Durham-based firm is developing oteseconazole (VT-1161), an oral antifungal product candidate, for the treatment of Recurrent Vulvovaginal Candidiasis (RVVC), a debilitating, chronic infectious condition that affects nearly 138 million women worldwide each year and for which there is currently no approved treatment in the United States.
“We are delighted by the progress we’re making with our oteseconazole clinical program, including the VIOLET trials,” said Stephen Brand, PhD, senior vice president of Clinical Development at Mycovia, in a statement. “The addition of an extension component to these studies will enable us to further evaluate the long-term effectiveness of oteseconazole in preventing recurrent episodes of vulvovaginal candidiasis in women who remain disease-free at their last scheduled study visit at Week 48.”
Brand continued: “The impact of RVVC on women is significant, as it reaches beyond the debilitating physical symptoms to emotional and psychological consequences, negatively affecting quality of life and resulting in an estimated annual economic burden of $14.4 billion due to lost productivity. We believe the data from the extension part of the trials will further validate oteseconazole’s potential as an important therapeutic option for women who are living with this chronic disease.’’
Oteseconazole is designed to be highly selective, with fewer side effects and improved efficacy over current treatment options, including the current standard of care for vaginal candidiasis, fluconazole. In previous clinical studies, including a Phase 2b trial in women with RVVC, oteseconazole was shown to have a positive impact in preventing disease recurrence, together with a favorable safety profile, with no discernable adverse effect on liver function, and has been generally well tolerated in more than 1,200 patients to date.
Mycovia currently has three ongoing Phase 3 trials evaluating the clinical effectiveness of oteseconazole in women with RVVC – two global trials (VIOLET) and one U.S. trial (ultraVIOLET). The trials, which are being conducted in 11 countries, completed enrollment in December 2019, enrolling more than 870 patients. All U.S. sites participating in the VIOLET trials will have the option to participate in the extension studies, which will be open to patients who remain disease-free at the conclusion of the initial 48-week period.
The extension studies will last an additional 48 weeks. Topline data from the VIOLET trials are expected in the second half of 2020, with an anticipated U.S. launch of oteseconazole in 2021.
More information about Mycovia’s Phase 3 trials can be found at clinicaltrials.gov under the identifier numbers NCT03561701 and NCT03562156 for the VIOLET trials and NCT03840616 for the ultraVIOLET trial.