- New interim analysis of the Phase 3 CARES study showed complete or partial response in 78% of the 18 patients treated with ibrexafungerp for infections caused by Candida auris, a potentially deadly and multidrug-resistent pathogen with an outbreak recently reported at a Detroit specialty hospital.1
- Interim data of the ongoing Phase 3 FURI and CARES studies of patients with invasive candidiasis and candidemia treated with ibrexafungerp is positive and consistent with previous analyses.
- Additional new in vivo data presented supports ibrexafungerp as a potential treatment for mucormycosis, a debilitating and sometimes deadly fungal infection that has seen an increase in cases globally during the COVID-19 pandemic.
JERSEY CITY, N.J., April 27, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced several poster presentations highlighting details from interim analyses of data from its ongoing Phase 3 FURI and CARES studies investigating the potential of ibrexafungerp as a treatment for invasive candidiasis (IC) and candidemia, including infections caused by Candida auris (C. auris). The posters were presented at the 32nd Annual European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) held in Lisbon, Portugal April 23-26, 2022.
“We are excited to share these latest data with the medical community as we advance our hospital clinical programs in invasive candidiasis, including candidemia,” said David Angulo, M.D. Chief Medical Officer of SCYNEXIS. “There is great unmet need for additional therapies to fight these infections, which can be quite serious, especially if the pathogen is resistant to current therapies, as can be the case with C. auris. We are proud to be a part of this important research.”
C. auris, a contagious fungal infection that can quickly spread in patients in hospital wards or nursing home facilities, has been designated as an “urgent threat” by the CDC.2 Invasive C. auris infections have a high mortality rate – more than one in three patients can die.3
“Many C. auris strains are resistant to at least two classes of antifungals, which makes these interim research findings of ibrexafungerp’s activity against this terrible pathogen so promising,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “The reported outbreak of C. auris at a specialty hospital in Detroit just last week underscores the urgency of finding new treatment options to battle this ongoing dangerous fungal public health threat.”
Below are highlights of the posters presented:
- Outcomes of Oral Ibrexafungerp in the Treatment of 18 Patients with Candida auris Infections, from the CARES StudyPresenter: R.S. Siebert (Pretoria, South Africa)Summary: SCYNEXIS presented results of an interim analysis of the CARES study of 18 enrolled patients with candidemia, lower urinary tract and intra-abdominal fungal infections caused by Candida auris (C. auris). In the analysis, 11 patients had received prior antifungal therapy for their infection. Following treatment with oral ibrexafungerp for a mean duration of 18 days, 78% of patients showed complete or partial response, 11% had stable disease, one patient died of other causes, and one outcome was indeterminate.
- Oral Ibrexafungerp Outcomes in Patients with Invasive Candidiasis and Candidemia from the FURI and CARES StudiesPresenter: Oliver Cornely (Cologne, Germany)Summary: SCYNEXIS presented interim analyses with combined data of 49 patients, who completed treatment for invasive candidiasis and candidemia between 2018 and 2020, as part of the ongoing Phase 3 FURI (n=39) and CARES (n=10) studies. Aggregate data from the two studies showed that of the patients treated with ibrexafungerp, 68% had complete or partial response; 14% had stable disease; 6% showed disease progression; 8% were indeterminate; and 4% died from progression of an underlying disease.
- Efficacy Assessment of Ibrexafungerp in the Neutropenic Mouse Model of Pulmonary MucormycosisPresenter: Ashraf Ibrahim (Torrance, Calif., United States)Summary: Preclinical data on ibrexafungerp from an investigational analysis were presented. The data were based on an in vivo mouse model of mucormycosis and support ibrexafungerp, a broad-spectrum antifungal, as an effective potential treatment for mucormycosis. The study found that when ibrexafungerp was combined with liposomal amphotericin B (LAMB) or posaconazole (POSA), synergistic benefits were observed with a statistically significant enhancement in median survival time and overall survival when compared to any one therapy alone (P