ibrexafungerp reaches a critical Phase 3 clinical endpoint for the treatment of gynecological fungal infections

- Apr 22, 2020-

Scynexis announced that it is studying the oral antibacterial drug ibrexafungerp, and reached the primary and secondary endpoints of the second key phase 3 clinical trial, VANISH-306, for patients with vulvovaginal candidiasis (VVC). The relevant data of the trial will support Scynexis to submit a new drug application (NDA) for ibrexafungerp to treat patients with VVC in the second half of this year.

Vulvovaginal candidiasis is the second most common vaginal infection in women. It is caused by Candida albicans. It mainly manifests as itching, burning, and abnormal leucorrhea of the vulva. . Globally, 70% -75% of women have been infected at least once in their lives, and 6% -8% of women have relapsed VVC. At present, the common therapies are local topical or oral azole antifungal drugs. Fluconazole is currently the only oral drug approved by the FDA to treat patients with acute VVC. For patients who have developed resistance to fluconazole, they urgently need new therapies to treat the disease.

Ibrexafungerp is a novel glucan synthase inhibitor that combines the good activity of glucan synthase inhibitors with the potential flexibility of oral and intravenous administration, and is expected to be widely used in inpatient and outpatient settings . Currently, the drug is being developed to treat fungal infections mainly caused by Candida and Aspergillus. In in vitro and in vivo studies, it has shown a broad spectrum of antifungal activity. Previously, the US FDA has granted ibrexafungerp Qualified Infectious Disease Product Qualification (QIDP), Fast Track Qualification, and Orphan Drug Qualification.

VANISH-306 is a randomized, double-blind, phase 3 clinical study of a placebo-containing control group to evaluate the efficacy of oral ibrexafungerp in the treatment of patients with VVC. The results of the trial showed that compared with the placebo group, on the 10th day of treatment, 63.3% of patients receiving ibrexafungerp reached the primary endpoint of clinical cure, that is, all vaginal signs and symptoms after treatment (S & S, score range 0 to 18) Completely subsided. 58.5% of patients reached the secondary endpoint of mycological eradication. 72.3% of patients achieved clinical improvement, that is, vaginal signs and symptoms reached 0 or 1. At the 25th day of follow-up, 73.9% of the patients' symptoms were completely eliminated.

"We are very satisfied with the results of the VANISH-306 trial, which is consistent with the previously reported VANISH-303 study results, and supports the efficacy and safety of oral ibrexafungerp as a new therapy for patients with VVC," SCYNEXIS Chief Medical Officer Officer David Angulo said: "Two phase 3 studies also confirmed the sustained clinical effect of ibrexafungerp at the 25th day of follow-up, which is consistent with the results of the phase 2b DOVE study. At the same time, we will continue to advance the progress of the phase 3 clinical study CANDLE To evaluate the effectiveness of ibrexafungerp in preventing recurrent vaginal yeast infections. We look forward to obtaining top-line data for the treatment of this indication in the second half of 2021. "