SCYNEXIS, based in Jersey City, New Jersey, announced positive results from its second interim efficacy analysis of its Phase III open-label FURI study. The trial is evaluating oral ibrexafungerp as a salvage treatment in difficult-to-treat mucocutaneous and invasive fungal infections that are refractory to or intolerant of current standards of care. It is also being studied in a patient group that requires a non-azole oral step-down therapy for treatment of azole-resistant Candida species.
A Data Review Committee (DRC) of independent experts looked at the data in a second cohort of 21 patients from the FURI study. Together with the 20 patients reported in January 2019, efficacy was consistent across both analyses. Oral ibrexafungerp showed benefit in 83% of patients with 23 patients hitting a complete or partial response and 11 patients demonstrating a stable disease response.
Of the 41 patients treated, only six didn’t respond to the drug and one patient was viewed as indeterminate.
The results support continued patient enrollment in the trial as well as a future New Drug Application (NDA) submission and potential approval under the FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).
“These interim results, combined with the positive Phase III data from our vulvovaginal candidiasis (VVC) program, confirm the potential for ibrexafungerp to be a transformative antifungal agent across a variety of indications, addressing needs in both the in-patient and out-patient markets,” said Marco Taglietti, president and chief executive officer of Scynexis. “We believe that ibrexafungerp combines the best attributes of existing antifungal classes, such as oral administration, broad spectrum activity including against resistant pathogens, and a favorable safety profile, enabling us to maximize its full potential across several indications to benefit patients in need, physicians who treat them, and the investment community that has supported our programs.”
Ibrexafungerp is the first representative of a novel class of structurally-distinct glucan synthase inhibitors called the “fungerps.” The company indicates that it combines the well-established activity of glucan synthase inhibitors with the possible flexibility of both oral and IV formulations. It is currently being developed for the treatment of fungal infections caused by Candida, including C. auris, and Aspergillus species.
The FDA has granted it both Qualified Infectious Disease Product (QIDP) and Fast Track designations for invasive candidiasis, invasive aspergillosis and vulvovaginal candidiasis. It also was granted Orphan Drug Designation for the invasive candidiasis and invasive aspergillosis indications.
“The positive results from this second interim analysis are fully consistent with the positive outcomes observed in the first interim analysis,” said David Angulo, Scynexis’ chief medical officer. “Patients enrolled in the FURI study typically suffer from complex underlying medical conditions, aggravated by a severe fungal infection. We are pleased to see many responding favorably to treatment with ibrexafungerp and are optimistic it will be a much-needed alternative for patients suffering from difficult-to-treat, severe fungal infections, particularly given the limited treatment options available and the increase in drug resistance.”
The company expects to meet with the FDA to discuss the preliminary data and its salvage therapy program.