Scynexis announced positive topline results from the phase 3 VANISH 303 trial of ibrexafungerp for the treatment of vulvovaginal candidiasis (VVC) in women.

Ibrexafungerp is an investigational antifungal agent belonging to a novel class of structurally-distinct glucan synthase inhibitors, known as triterpenoids. It has been shown to have broad spectrum antifungal activity against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains.

The multicenter, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of ibrexafungerp (SCY-078) for acute VVC in 376 patients aged ≥12 years with a signs and symptoms score of ≥4 on a scale of 0-18. Patients were randomized 2:1 to receive either oral ibrexafungerp 300mg or placebo twice a day for 1 day. The primary end point was clinical cure, defined as complete resolution (score of 0) of all signs and symptoms at Day-10 test-of-cure (TOC) visit; key secondary end points included mycological eradication and clinical improvement (score of 0 or 1) at TOC.

Results showed that clinical cure at the TOC visit was 50.5% with ibrexafungerp, which was statistically superior to placebo (P =.001). In addition, mycological eradication and clinical improvement was observed in 49.5% (P <.001) and 64.4% (P <.001) of patients treated with ibrexafungerp, respectively. Efficacy results from the VANISH 303 trial are consistent with those observed in the phase 2b DOVE trial. Full comprehensive analysis of trial data is still ongoing.

With regard to safety, the most common treatment-emergent adverse events were diarrhea (25.5%), nausea (16.6%), and abdominal pain (7.3%), which were mostly regarded as mild and of short duration.

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“Ibrexafungerp is the first molecule in an entirely new class of antifungals and possesses key attributes relevant to the VVC indication, including fungicidal activity against Candida,” said Dr Marco Taglietti, President and Chief Executive Officer of Scynexis. “We believe that ibrexafungerp, as a novel, non-azole, oral therapy, can address large unmet medical needs for women with VVC who may not respond to fluconazole, the only oral option currently available, which is fungistatic against Candida and also has well-documented concerns around drug-drug interactions and embryo-fetal toxicity for women of childbearing age.”

The Company is currently conducting the phase 3 VANISH 306 trial with anticipated data to be available in Q2 of 2020. The safety and efficacy data from these two phase 3 studies are expected to support the New Drug Application (NDA) for ibrexafungerp in the second half of 2020. 

Additional studies for ibrexafungerp are being investigated for its use in recurrent VVC (phase 3 CANDLE trial) as well as an open-label sub-study for patients unresponsive to oral fluconazole

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