'Never been more urgent:' Scynexis looks to tackle superbug crisis with late-stage readout for antifungal hopeful
As the superbug crisis heats up around the world, Scynexis says it has new data from two interim analyses that prove its antifungal has the potential to treat a broad range of infections.
“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,” CEO Marco Taglietti said in a statement.
The interim results come from two open-label Phase III trials for oral ibrexafungerp, dubbed FURI and CARES. In the FURI trial, the triterpenoid 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. In the latest efficacy analysis, a data review committee observed “clinical benefit” in 30 of the 33 patients in a third cohort of patients, and no disease progression, according to Scynexis.
Across the whole FURI study, 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. Five patients didn’t respond to ibrexafungerp, one died of an unrelated underlying condition, and four were considered “indeterminate,” Scynexis reported.
The CARES analysis included only 10 patients who were hospitalized with candidiasis and candidemia due to the fungus Candida auris. The organism is often multi-drug resistant, and made the CDC’s list of Urgent Threats to public health. Based on information from a limited number of patients, the CDC estimates that 30% to 60% of people with C. auris infections die (though many have other serious illnesses that also increase risk of death). The microbe is easily spread in healthcare settings, and cases have risen during the pandemic.
“C. auris attaches from person to person, to things, to clothes, to the walls. This is why the CDC is so concerned about this pathogen, it’s very sticky, very persistent and tends to spread,” Taglietti told Endpoints News in 2019.
In the CARES analysis, eight of 10 patients achieved a complete response, according to Scynexis. There was one death unrelated to the treatment, and one indeterminate patient.
In an aggregate analysis of both the FURI and CARES data, 64% of the 84 patients treated achieved a partial or complete response, on top of 21% patients who achieved stable disease.
The drug was well-tolerated, CMO David Angulo said during an investor call on Tuesday, with the most common treatment-related side effects being gastrointestinal issues.
“Results from these ongoing studies continue to encourage us about oral ibrexafungerp’s potential as a powerful and well-tolerated antifungal agent, capable of addressing significant unmet medical needs across a variety of infections,” Angulo said during the call. “We will continue to enroll patients in this hospital program, and to release additional details in patient cases from these interim analyses at upcoming scientific meetings.”
Scynexis plans on bringing the FURI and CARES data to the FDA under the Limited Population Pathway for Antibacterial and Antifungal Drugs, which was established in 2016 to streamline the development and approval of certain candidates for serious and life-threatening infections in limited populations of patients with unmet needs.
Ibrexafungerp is already before regulators for the treatment of vaginal yeast infection, with a PDUFA date of June 1. If approved, it could mark the first new antifungal class in more than two decades, according to Taglietti.