ibrexafungerp Phase 3 Data Shows Promising Results for Acute Treatment of CVD

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

The open-label CANDLE substudy enrolled 24 patients with RVVC who did not respond to treatment with fluconazole, which was given as initial treatment at 3 doses over 7 days. Fluconazole failure was defined as a persistent vaginal signs and symptoms score of 3 or greater after treatment.

Participants received a one-day course 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 pleased to present these data demonstrating positive outcomes in patients with RVVC who failed fluconazole treatment for an acute episode of VVC,” 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 in treating recurrent yeast infections in patients with limited treatment options. We hope to expand on this data with the recently announced Phase 3b VANQUISH study. »

Scynexis plans to present key findings from CANDLE next month at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology to be held in Boston, August 4-6, 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 post-menarchic pediatric patients.1

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

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

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

References

  1. SCYNEXIS Presents Positive Data from Phase 3 CANDLE Nested Sub-Study of Ibrexafungerp in Women With Recurrent Yeast Infections Who Failed Fluconazole at ISSVD XXVI World Congress and Update international conference on vulvovaginal diseases. 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

About Susan Dailey

Check Also

It takes longer to get a doctor’s appointment, survey finds

Listen to the article 3 minutes This audio is generated automatically. Please let us know …