Scynexis will pit a new class of antifungals against yeast infections — and it won't come cheap
The FDA ushered in a new class of triterpenoid antifungals this week, giving Scynexis the OK for its oral ibrexafungerp — a non-azole treatment the company designed to dethrone Pfizer’s fluconazole in vaginal yeast infection.
The decision came right on time for Scynexis’ June 1 PDUFA date, and was based on two Phase III trials in which about 50% and 63% of patients given the drug, respectively, saw all signs and symptoms of their yeast infections disappear by day 10.
Just about 29% and 44% of patients on the placebo saw a clinical cure by Day 10, according to data presented at the American College of Obstetricians and Gynecologists in April. By Day 25, symptom resolution in the treatment arms increased to 60% and nearly 74%, Scynexis reported.
“This first approval in the U.S. is a major step towards building the ibrexafungerp antifungal franchise as we intend to leverage an extended 10-year period of regulatory exclusivity and 14 years of patent protection,” CEO Marco Taglietti said in a statement.
Though vaginal yeast infections — also known as vulvovaginal candidiasis (VVC)— affect three out of four women across their lifetimes, the condition has limited treatment options. Fluconazole was approved by the FDA as Diflucan in 1990, and now has many equivalents on the market.
Ibrexafungerp — now marketed as Brexafemme — was approved as a first-line treatment, but Taglietti told Endpoints News last year that the drug can also be used on patients who don’t respond to fluconazole, adding that the drug will be priced at a premium. At the time, he estimated the drug would come at a list price of $300 to $400, which would work out to a copay of $25 to $30.
The drug is also being evaluated in patients with recurrent VVC in a Phase II study dubbed CANDLE. Angulo said on Wednesday that Scynexis is “working on completing” that trial, and expects to submit a supplemental NDA in the first half of 2022.
Mycovia could beat it to the punch though, announcing on Tuesday that it submitted an NDA for its oral antifungal oteseconazole in RVVC. Combined Phase III data showed that the drug protected more than 90% of participants from having a recurrence for nearly a year, according to Mycovia.
Back in March, Scynexis unveiled interim results from two open-label Phase III trials testing oral ibrexafungerp in a range of infections. In the first, called FURI, the drug was given to patients with difficult-to-treat mucocutaneous and invasive fungal infections that are resistant to or intolerant of current standards of care, or who require a non-azole oral step-down therapy for the treatment of azole-resistant species. Clinical benefit was shown in 86.5% of 74 patients treated, with 46 patients achieving a complete or partial response and 18 patients achieving a stable disease response, according to the company.
The second analysis, dubbed CARES, included 10 patients who were hospitalized with candidiasis and candidemia due to the fungus Candida auris. The organism is often multi-drug resistant, and recently made the CDC’s list of Urgent Threats to public health. Eight of the patients achieved a complete response, according to Scynexis.