Scynexis announced positive topline results from a second phase 3 study of ibrexafungerp for the treatment of vulvovaginal candidiasis (VVC). 

Ibrexafungerp is an investigational oral antifungal agent belonging to a novel class of structurally-distinct glucan synthase inhibitors known as triterpenoids. In the VANISH 306 trial, 188 patients with acute VVC were randomized to receive ibrexafungerp (300mg twice daily for 1 day) or placebo in a 2:1 ratio. The primary end point of the trial was clinical cure rate, defined as the complete resolution of all signs and symptoms at the Test-of-Cure (TOC) visit on day 10.

Results showed 63.3% of the ibrexafungerp-treated patients met the primary end point of clinical cure at the Day-10 TOC visit (P ≤.01), and 58.5% of ibrexafungerp-treated patients met the secondary end point of mycological eradication at the TOC visit (P ≤.001). Additionally, it was found that 73.9% of ibrexafungerp-treated patients had complete symptom resolution at the day 25 follow-up (P ≤.001).

Gastrointestinal side effects made up the majority of treatment-emergent adverse in patients treated with ibrexafungerp.The 3 most common GI events were diarrhea/loose stool, nausea and abdominal pain, which occurred in 9.4%, 8.4% and 2.7% of patients, respectively.

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The combined results from VANISH 306 and the previous phase 3 study, VANISH 303, will be included in the NDA for ibrexafungerp, which the Company expects to submit later this year.

“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,” said David Angulo, MD, CMO of Scynexis. “In parallel, we continue to advance our CANDLE phase 3 study testing oral ibrexafungerp for the prevention of recurrent vaginal yeast infections [ … ] and expect top-line data in this indication in the second half of 2021.”

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