SCYNEXIS, Inc. announced this week positive top-line results for its Phase 3 VANISH-306 study investigating the safety and efficacy of oral ibrexafungerp, a novel broad-spectrum antifungal, as a treatment for women with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. With these results, ibrexafungerp has now achieved superiority over placebo with a high degree of statistical significance on key study endpoints required for regulatory approval of the VVC indication in both VANISH pivotal trials, clearing the way for the NDA submission for the treatment of VVC in the second half of 2020.
“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,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. “Both VANISH Phase 3 studies also confirmed ibrexafungerp’s sustained clinical effect at the Day-25 follow-up visit, consistent with findings from the Phase 2b DOVE study. In parallel, we continue to advance our CANDLE Phase 3 study testing oral ibrexafungerp for the prevention of recurrent vaginal yeast infections, for which there are no approved therapies, and expect top-line data in this indication in the second half of 2021.”
Marco Taglietti, M.D., Chief Executive Officer of SCYNEXIS added, “This marks the successful completion of our VANISH Phase 3 program, with planned NDA submission to the FDA later this year. If approved, ibrexafungerp would be the first and only oral, non-azole treatment for vaginal yeast infections – a condition that affects three out of four women in their lifetime but has limited treatment options, with no new approved therapies in over 20 years. 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.”
VANISH-306 Efficacy Results:
- 63.3 percent of ibrexafungerp-treated patients met the primary endpoint of clinical cure at the Day-10 test-of-cure (TOC) visit, defined as the complete resolution of all vaginal signs and symptoms (S&S) following a single-day 600mg dose regimen consisting of two doses of 300mg administered 12 hours apart.
- 58.5 percent of ibrexafungerp-treated patients met the secondary endpoint of mycological eradication at TOC visit, defined as negative culture.
- 72.3 percent of ibrexafungerp-treated patients were categorized as clinically improved at TOC visit, defined as having total signs and symptoms of 0 or 1.
- 73.9 percent of ibrexafungerp-treated patients had complete symptom resolution at the Day-25 follow-up (FU) visit.
In VANISH-306, oral ibrexafungerp was generally safe and well tolerated. Severe and serious adverse events (AEs and SAEs) were rare and there were no drug-related SAEs. Similar to previous studies, the majority of Treatment-Emergent AEs (TEAEs) observed at a higher frequency in the ibrexafungerp group in VANISH-306 were gastrointestinal (GI) in nature, with the three most common GI events (diarrhea/loose stool, nausea and abdominal pain) occurring at rates of 9.4%, 8.4% and 2.7%, respectively. These events were predominantly regarded as mild, of short duration and did not lead to discontinuation, confirming the favorable tolerability profile of the single-day 600mg dose regimen of oral ibrexafungerp that was previously observed.
The combined safety database of the VANISH and DOVE programs in VVC patients now includes more than 850 enrolled patients, with 575 treated with the one-day 600mg dose regimen of ibrexafungerp. The overall incidence of the most common GI events for ibrexafungerp-treated patients in the total database was 16.7% for diarrhea/loose stool, 11.8% for nausea and 4.5% for abdominal pain, supporting the favorable safety and tolerability profile of ibrexafungerp.
For more information about the VANISH-306 study go to: https://clinicaltrials.