SCYNEXIS Reports Favorable Interim Phase 3 Results for Ibrexafungerp

SCYNEXIS has announced results from the first interim efficacy analysis of the ongoing FURI study evaluating oral ibrexafungerp, reporting that the agent has been effective in treating mucocutaneous and invasive fungal infections that do not respond to other therapies.

"Ibrexafungerp is a novel glucan synthase inhibitor (triterpenoid) available in both intravenous and oral forms," Oliver Cornely, MD, director of Clinical Trials Centre University of Cologne, Germany, told Contagion^® in an interview. "It is a new class that is different than the three major classes of antifungals currently in the market: azoles, echinocandins and polyenes. If approved, it would be the first new class available for physicians and patients in 20 years."

Ibrexafungerp, formerly known as SCY-078, is in development for the treatment of fungal infections caused by Candida and Aspergillus species.

FURI is a phase 3, multicenter open label, non-comparator, single arm study evaluating oral ibrexafungerp as a salvage treatment in patients with difficult-to-treat fungal infections that are refractory to or intolerant of currently available standards of care.

Patients are also considered for enrollment if they have an eligible fungal disease and cannot receive approved antifungal options due to organism susceptibility or risk for drug-drug interactions, or if continued IV therapy is not feasible due to clinical or logistical circumstances.

The 20 patients in the interim analysis suffered from fungal infections including esophageal candidiasis, intra-abdominal abscesses, and oropharyngeal candidiasis. The most commonly observed fungal species were Candida glabrata and Candida krusei, both of which are highly resistant.

Enrolled participants receive an initial dose of 750 mg of oral ibrexafungerp twice a day for the first 2 days of treatment followed by 750 mg of the oral agent once a day for up to 90 days.

The participants are evaluated several times during treatment and the efficacy of treatment is assessed at the end of therapy. The subjects are then followed for another 6 weeks. In the interim analysis, treatment ranged from 7 to 90 days, with a mean duration of 36.4 days.

An independent expert panel assessed the efficacy of ibrexafungerp in the first 20 treated participants and found that 17 participants displayed signs of clinical benefit. Of the 20 participants, 11 achieved complete or partial response and 6 patients achieved a stable disease response. Of the remaining 3 patients, 2 did not respond to treatment and 1 had an indeterminate response.

The company reports that oral ibrexafungerp was well-tolerated in this interim analysis. Common adverse events were classified as gastrointestinal, no deaths were reported due to progressive fungal disease, and no safety signals warranted changes in the study.

Along with demonstrating the ability to treat fungal infection in patients for whom other therapies did not generate response, the company indicates that results support additional enrollment into the study.

"These preliminary positive data are significant because they showed the ability of oral ibrexafungerp to treat fungal infections in vulnerable patients who failed other therapies and these data also clearly support continued patient enrollment in the FURI study," Dr. Cornely continued. "These data may also re-assure physicians that this experimental agent is appropriate to be used to treat these difficult-to-treat infections."

In the past, the agent has demonstrated broad-spectrum activity in vitro and in vivo against drug-resistant pathogens including azole- and echinocandin-resistant strains.

The US Food and Drug Administration has granted Qualified Infectious Disease Product and Fast Track designations to the agent for the indications of invasive candidiasis invasive aspergillosis and vulvovaginal candidiasis. The agent has also received an Orphan Drug Designation for the invasive candidiasis and invasive aspergillosis indications.

SCYNEXIS plans to release additional details and patient cases of the FURI interim analysis at an upcoming scientific meeting.