Scynexis' lead drug scores in vaginal yeast infection trial
Antifungal drug developer Scynexis, which burst into the zeitgeist as one of the sole US-based companies with a Candida auris therapy in human trials, on Thursday disclosed that the same experimental drug had hit the main goal in a late-stage trial in patients with vaginal yeast infections.
The oral drug, ibrexafungerp, was being tested in the 376-patient, placebo-controlled VANISH-303 trial. Patients enrolled had experienced an acute episode of vulvovaginal candidiasis (VVC), with signs and symptoms score of four or greater on a scale of zero to 18.
The drug induced a ‘clinical cure’ (defined as complete resolution — or score of 0 — at the test-of-cure visit on day 10), rate of 50.5%, marking a statistically significant performance over the placebo arm (p=0.001), Scynexis said.
The secondary endpoint of mycological eradication was also met. On the safety side, severe adverse events were rare, but there were more cases reported in the placebo group than the ibrexafungerp group, the company added.
Another twin late-stage study testing ibrexafungerp, called VANISH-306, is being conducted — and data is expected next year. Assuming it is positive, results from both trials will be used to submit a marketing application in the second half of 2020. (The drug is also being evaluating for use in the CANDLE study in patients with recurrent VVC — the results are expected in 2021. )
“We believe that ibrexafungerp, as a novel, non-azole, oral therapy, can address large unmet medical needs for women with VVC who may not respond to fluconazole, the only oral option currently available, which is fungistatic against Candida and also has well-documented concerns around drug-drug interactions and embryo-fetal toxicity for women of childbearing age,” Scynexis chief Marco Taglietti said in a statement on Thursday.
Ibrexafungerp, if approved, could end up as the only oral alternative to fluconazole approved for acute VVC infections, although Mycovia is testing another therapy, VT-1161, for patients with recurrent VVC, Needham’s Alan Carr wrote in a note, adding that he expects ibrexafungerp to launch in 2021.
“Our data suggest 15% of pts return to their physician because existing treatments are inadequate…physician interest in a new drug is high and we estimate even modest (25%) penetration of the second-line setting generates peak sales (for ibrexafungerp) of over $450M.”
It has been decades since a fresh family of antifungals has come on to the market — at the moment there are three classes of antifungals in clinical use, including azoles and echinocandins. The most popular antifungals in use today were introduced in the 1980s and this class is increasingly losing its potency, as fungal pathogens become more resistant.
Scynexis’s ibrexafungerp belongs to a new class of antifungals called glucan synthase inhibitors, and has shown to be effective against a broad range of fungal infections, including resistant strains, Taglietti told Endpoints News in a prior interview.
One of the biggest challenges facing the field of antifungal drug development is the lack of incentives, such as those afforded to companies in the antibacterial and antiviral space, he said, adding that when Scynexis approached BARDA for funding, they were told antifungals were not a priority in Washington.
“I hope this awareness will now reach Washington.”