The SCYNEXIS Phase 3 CARES study is evaluating oral ibrexafungerp in hospitalized patients with invasive candidiasis caused by Candida auris, an organism that is often multidrug-resistant.
JERSEY CITY, NJ—SCYNEXIS Inc., a biotechnology company that develops medicines for hard to treat and drug-resistant infections, announced positive results from the third interim efficacy analysis of its ongoing open-label Phase 3 FURI study and the first interim analysis of its ongoing open-label Phase 3 CARES study. Each study is intended to support a potential future NDA submission through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).
The global, open-label Phase 3 FURI study is evaluating oral ibrexafungerp as a salvage treatment for patients with a variety of difficult-to-treat mucocutaneous and invasive fungal infections that are refractory to or intolerant of current standards of care or require a non-azole oral step-down therapy for the treatment of azole-resistant species. The global, open-label Phase 3 CARES study is evaluating hospitalized patients with invasive candidiasis caused by the emerging Candida auris, an organism that is often multidrug-resistant, associated with high mortality, and classified by the Centers for Disease Control and Prevention as an urgent threat to public health.
Candida auris can easily spread through contact in healthcare facilities, triggering hard to control outbreaks. Increased global C. auris cases have been associated with higher rates of hospitalization because of the COVID pandemic.
At a presentation for investors, SCYNEXIS company representatives explained that fungal infections are among the most difficult diseases to manage in humans, with 1.7 billion individuals suffering from these infections worldwide. The overall mortality in patients with invasive fungal infections can be 45 percent, depending on the pathogen and status of the patient.
Only three main classes of antifungals are approved for the treatment of invasive fungal infections: polyenes, azoles, and echinocandins. Only azoles have an oral option, but they have limitations because of resistance, side effects, and drug-drug interactions. Treatment duration is often several weeks, where the oral option is preferred.
Recently, there has been a rise in resistant species and isolates, including azole-resistant Aspergillus species and non-albicans Candida species with decreased azole susceptibility. New antifungal therapies are needed to reduce the high mortality of invasive fungal disease, combat the emergence of resistance to existing therapies, and provide clinicians with another oral treatment option, SCYNEXIS representatives said.
SCYNEXIS recently announced positive results from the third interim efficacy analysis of its ongoing open-label Phase 3 FURI study and the first interim analysis of its ongoing open-label Phase 3 CARES study—both of which are aimed at hard-to-treat fungal infections.
CREDIT: SCYNEXIS Inc.
Ibrexafungerp is an investigational antifungal agent and the first representative of triterpenoids, a novel class of structurally distinct glucan synthase inhibitors. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is currently under regulatory review for the treatment of vaginal yeast infection, also known as vulvovaginal candidiasis (VVC), and in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity—in vitro and in vivo—against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains.
The FDA has accepted a New Drug Application for ibrexafungerp for the treatment of VVC and granted a Prescription Drug User Fee Act action date of June 1, 2021. It also granted Qualified Infectious Disease Product and Fast Track designations for the intravenous and oral formulations of ibrexafungerp for the indications of invasive candidiasis (IC)—including candidemia—and invasive aspergillosis (IA), and has granted Orphan Drug Designation for the IC and IA indications.
Oral ibrexafungerp exhibited a positive safety profile and was well tolerated, with gastrointestinal issues being the most common treatment-related adverse events. There were no safety signals requiring changes to the studies.
“The consistently positive results from these analyses demonstrate the potential of oral ibrexafungerp to provide a flexible treatment option for combating serious life-threatening fungal infections, including those caused by the frequently drug-resistant Candida auris,” remarked Marco Taglietti, president and CEO of SCYNEXIS. “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. Ibrexafungerp is a versatile antifungal agent with potential to be a transformative therapy for multiple indications in both the hospital and community settings. It could be the first new antifungal class in more than two decades.”
According to David Angulo, chief medical officer of SCYNEXIS, “The strong results observed across the FURI and CARES trials are highly consistent with what has been previously reported despite the diversity of medical conditions and organisms being treated. We believe these results are indicative of ibrexafungerp’s broad-spectrum activity, which could provide a new valuable treatment option for patients suffering from a range of severe and often life-threatening fungal infections.”
“We believe ibrexafungerp is the first investigational agent with reported clinical data in patients with C. auris infections and, given the historical difficulty of treating this pathogen, the results are particularly promising. We look forward to evaluating additional data as these trials continue to enroll patients.”
SCYNEXIS Inc. https://www.scynexis.com/