Ibrexafungerp shows promise against recurrent vulvovaginal candidiasis in phase 3 trial
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Oral ibrexafungerp demonstrated a sustained advantage over placebo in the prevention of recurrent vulvovaginal candidiasis in a phase 3 trial, Scynexis announced Thursday.
Ibrexafungerp, branded as Brexafemme, was approved for use in June for the treatment of vulvovaginal candidiasis (VVC) — the first approved drug in a novel antifungal class in more than 20 years.
There are currently no approved treatments for the prevention of recurrent VVC, but Scynexis said it will submit the new phase 3 data to the FDA in the first half of 2022 and expects that ibrexafungerp tablets will be approved for this indication by the end of the year.
"Ibrexafungerp is the only oral fungicidal agent to successfully complete pivotal trials in both the acute treatment and prevention of yeast infections,” Marco Taglietti, MD, president and CEO of Scynexis, said in a press release. “As the only non-azole, we believe ibrexafungerp is changing how yeast infections are treated. These important results support an additional indication for Brexafemme for the prevention of recurrent VVC.”
The phase 3 trial assessed the safety and efficacy of oral ibrexafungerp compared with placebo among 260 female patients with recurrent VVC. Participants initially received a 3-day regimen of fluconazole and then were randomly assigned to receive either 300 mg of ibrexafungerp or a matching placebo, 1 day a month, for 6 months.
Among participants who received ibrexafungerp, 65.4% experienced no recurrence through week 24 compared with 53.1% in the placebo arm, according to Scynexis. The advantage was sustained over a 3-month follow-up period, the company said.
Additionally, experts assessed 24 patients who failed to respond to the initial 3-day regimen of fluconazole who each received a 1-day open-label treatment course (300 mg) of ibrexafungerp. Among them, 71% achieved a significant reduction or elimination of signs and symptoms, Scynexis said.
Ibrexafungerp was generally safe and well tolerated, the company reported, with no serious drug-related adverse events. No patients with ibrexafungerp discontinued treatment.
“After developing ibrexafungerp as the first approved oral non-azole agent to treat VVC, this study shows that it also prevents recurrences of the disease, as well as helps patients who failed to respond to multiple doses of fluconazole,” David Angulo, MD, Scynexis’ chief medical officer, said in the release. “We are excited to see these important results that further demonstrate the unmatched abilities of ibrexafungerp as a powerful oral antifungal therapy with potential broad utility against fungal infections. This is excellent news for women seeking relief from challenging and recurring yeast infections.”
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