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Phase 3 ibrexafungerp data shows promising results for acute VVC treatment

The CANDLE open-label sub-study enrolled 24 patients with RVVC who failed to respond to fluconazole treatment, which was given as an initial 3-dose treatment over 7 days.

Data from Scynexis’ CANDLE 304s nested sub-study showed promise for the potential treatment of acute vulvovaginal candidiasis (VVC) episode in women with recurrent vulvovaginal candidiasis (RVVC) patients who were not responsive to a 7-day fluconazole regimen of 3 doses. The data was presented at the International Society for the Study of Vulvovaginal Diseases (ISSVD) XXVI World Congress and International Vulvovaginal Disease Update 2022 held in Dublin, Ireland, from July 15 to 20, 2022.

The CANDLE open-label sub-study enrolled 24 patients with RVVC who failed to respond to fluconazole treatment, which was given as an initial 3-dose treatment over 7 days. Fluconazole failure was defined as persistent vaginal signs and symptoms score equal to or greater than 3 after therapy.

Participants received a 1-day treatment of ibrexafungerp (300 mg twice daily). In this population, 71% of patients (n = 17) achieved a significant reduction or elimination of signs and symptoms after treatment with ibrexafungerp.

“We are thrilled to present these data demonstrating positive outcomes in RVVC patients who failed fluconazole therapy for an acute VVC episode,” said Nkechi Azie, MD, vice president of clinical development and medical affairs at Scynexis.

She added, “The response to ibrexafungerp in this clinically challenging population is extremely encouraging and further demonstrates the potential efficacy of ibrexafungerp to treat recurrent yeast infections in patients with limited treatment options. We hope to expand upon these data with the recently announced Phase 3b VANQUISH study.”

Scynexis plans to present CANDLE main results next month during the Infectious Diseases Society for Obstetrics and Gynecology Annual Meeting being held in Boston, August 4 to 6, 2022.

Currently, ibrexafungerp was approved by the FDA for the treatment of VVC in June 2021, making it the first and only oral fungicidal treatment for VVC in adults and postmenarchal pediatric patients.1

In June 2022, Scynexis submitted a supplemental New Drug Application to the US Food and Drug Administration (FDA) for ibrexafungerp tablets (Brexafemme; Scynexis) for the prevention of recurrent vulvovaginal candidiasis (RVVC).2

The submission was based on positive results from the CANDLE study, which showed that ibrexafungerp successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints.2

If the sNDA is approved, ibrexafungerp would be the first and only oral non-azole medication for RVVC prevention on the market, according to a company press release.2

References

  1. SCYNEXIS Presents Positive Data from Phase 3 CANDLE Nested Sub-Study Investigating Ibrexafungerp in Women with Recurrent Yeast Infections Who Failed Fluconazole During the ISSVD XXVI World Congress and International Vulvovaginal Disease Update. SCYNEXIS. July 19, 2022. Accessed July 21, 2022. https://ir.scynexis.com/press-releases/detail/296/scynexis-presents-positive-data-from-phase-3-candle-nested
  2. Petronelli M. Scynexis submits sNDA for expanded indication of ibrexafungerp tablets. Contemporary OB/GYN. June 8, 2022. Accessed July 21, 2022. https://www.contemporaryobgyn.net/view/scynexis-submits-snda-for-expanded-indication-of-ibrexafungerp-tablets