The New Drug Application (NDA) for ibrexafungerp (SCY-078; Scynexis) for the treatment of vulvovaginal candidiasis has been submitted to the Food and Drug Administration (FDA).
Ibrexafungerp is an investigational oral antifungal agent representing a novel therapeutic 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 NDA submission is supported by data from 2 multicenter, randomized, double-blind, placebo-controlled phase 3 studies (VANISH-303 and VANISH-306) that compared the efficacy and safety of ibrexafungerp to placebo in female patients aged 12 years and older with acute vulvovaginal candidiasis. Both trials showed that ibrexafungerp was statistically superior to placebo with regard to the primary end point of clinical cure, defined as the complete resolution of all signs and symptoms at the test-of-cure visit on day 10.
As for safety, gastrointestinal side effects made up the majority of adverse events in patients treated with ibrexafungerp. The 3 most common GI events were diarrhea/loose stool, nausea and abdominal pain.
“The submission of this NDA marks the next step toward bringing the first new class of oral antifungals in over 20 years to women suffering from vaginal yeast infections and their healthcare providers, who, to date, have had only 1 class of medications,” said Marco Taglietti, MD, President and Chief Executive Officer of Scynexis.
For more information visit scynexis.com.
- Scynexis announces submission of New Drug Application to the US Food and Drug Administration for oral ibrexafungerp for the treatment of vaginal yeast infection. [press release]. Jersey City, NJ: Scynexis; October 14, 2020.
- Scynexis announces positive top-line results from its second pivotal phase 3 study (VANISH-306) of oral ibrexafungerp for the treatment of vulvovaginal candidiasis (vaginal yeast infection). [press release]. Jersey City, NJ: Scynexis; April 21, 2020.