SCYNEXIS Posts Positive Phase III Data with Oral Treatment for Vaginal Yeast
Shares of New Jersey-based SCYNEXIS are climbing in premarket trading after the company announced positive results from its second Phase III study investigating oral ibrexafungerp as a treatment for vaginal yeast infection, a condition that impacts approximately 75% of women across the globe.
Ibrexafungerp is a broad-spectrum antifungal agent that represents the first novel therapeutic class in more than 20 years for vulvovaginal candidiasis, the company said this morning. Despite the wide impact of vaginal yeast infection, there is only one approved oral treatment on the market, the anti-fungal Diflucan (fluconazole). With the Phase III results, ibrexafungerp achieved highly statistically significant superiority over placebo for the primary and key secondary study endpoints, SCYNEXIS said.
In the VANISH-306 trial, 63.3% of ibrexafungerp-treated patients met the primary endpoint of clinical cure after 10 days. Clinical cure is defined as the complete resolution of all vaginal signs and symptoms following a single-day 600mg dose regimen, the company said. Additionally, 58.5% of ibrexafungerp-treated patients met the secondary endpoint of mycological eradication, which was defined as negative culture. At a 25-day follow-up visit, 73.9% of ibrexafungerp-treated patients had complete symptom resolution, SCYNEXIS added.
Results announced today from the VANISH-306 trial, along with previously announced results from VANISH 303, will provide the basis for an anticipated New Drug Application with the U.S. Food and Drug Administration in the second half of this year, the company said. In the VANISH-303 study, ibrexafungerp achieved superiority over placebo at a highly statistically significant level for its primary endpoint of clinical cure. In that study, the observed clinical cure for ibrexafungerp was 50.5%, showing highly statistically significant superiority to placebo, the company reported in November.
“We are thrilled with the results from VANISH-306, which are consistent with the previously reported VANISH-303 study findings in supporting the efficacy and safety of oral ibrexafungerp as a novel treatment for women with vaginal yeast infections,” David Angulo, chief medical officer of SCYNEXIS said in a statement. “Both VANISH Phase III studies also confirmed sustained clinical effect at the Day-25 follow-up visit, consistent with findings from the Phase IIb DOVE study.”
Chief Executive Officer Marco Taglietti said if ibrexafungerp is approved, it will become the “first and only oral, non-azole treatment for vaginal yeast infections” in the United States.
“The positive results from our VANISH program give us confidence that ibrexafungerp has the potential to address vaginal yeast infections across a broad range of disease severity, and could be an ideal treatment option particularly for patients not currently satisfied with existing therapies,” Taglietti said in a statement.
While the VANISH program is complete, SCYNEXIS continues to advance its Phase III CANDLE study assessing oral ibrexafungerp for the prevention of recurrent vaginal yeast infections. There are no approved therapies for this condition and the company anticipates top-line data in the second half of 2021.