Antifungal Shows Promising Results with Interim Phase 3 Data
Investigational therapy, ibrexafungerp, from Scynexis is being studied for fungal infections and is moving closer towards a goal of FDA approval later this year.
Jersey City, New Jersey-based Scynexis announced today its positive results from the third interim efficacy analysis of its ongoing open-label phase 3 FURI study and the first interim analysis of the ongoing open-label phase 3 CARES study for its therapy, ibrexafungerp.
This investigational therapy is a broad-spectrum, IV and oral antifungal agent representing a novel therapeutic class. It is in late-stage development for multiple indications, ranging from vaginal yeast infections to life-threatening fungal infections in hospitalized patients.
A data review committee assessed the efficacy of oral ibrexafungerp in a third cohort of 33 patients from the FURI study and 10 patients from the CARES study. The third interim analysis of the FURI study showed that antifungal activity was consistently positive across all interim analyses with ibrexafungerp showing clinical benefit in 30 out 33 patients, and no patient with progression of disease.
On an aggregate basis, oral ibrexafungerp showed clinical benefits in 86.5% of patients (64 out 74), with 46 patients achieving a complete or partial response and 18 patients achieving a stable disease response. Of the 74 treated patients, only five did not respond to ibrexafungerp treatment, one patient died of an underlying condition unrelated to the treatment and four patients were considered indeterminate.
Analysis of the CARES study found that 80% (8 out 10) patients with invasive candidiasis and candidemia, due to C. auris, experienced a complete response, and one patient died of an underlying condition unrelated to the treatment and one patient was considered indeterminate.
“The strong results observed across the FURI and CARES trials are highly consistent with what has been previously reported despite the diversity of medical conditions and organisms being treated,” Scynexis CMO David Angulo, MD, said. “We believe these results are indicative of ibrexafungerp’s broad-spectrum activity, which could provide a new valuable treatment option for patients suffering from a range of severe and often life-threatening fungal infections.”
The company is expecting its first commercial launch of ibrexafungerp in 2021. Back in December, Scynexis announced the US Food and Drug Administration (FDA) had accepted the company’s filing for a new drug application (NDA) for its oral formulation of ibrexafungerp for treatment of vaginal yeast infection.
“The consistently positive results from these analyses demonstrate the potential of oral ibrexafungerp to provide a flexible treatment option for combating serious life-threatening fungal infections, including those caused by the frequently drug-resistant Candida auris,” Scynexis President and CEO Marco Taglietti, MD, said. “The need for new anti-infectives capable of fighting the most resistant pathogens has never been more urgent as we confront the ongoing COVID-19 global pandemic.”
Contagion® spoke with Scynexis CEO Marco Taglietti, MD, a few months ago about ibrexafungerp and interested readers can view the interview here.