- In vivo data demonstrated response rate for ibrexafungerp similar to current standard of care options for the treatment of mucormycosis
- Combination of ibrexafungerp with current therapies showed significant enhancement in median survival time and overall survival when compared with standard of care monotherapies
JERSEY CITY, N.J., Oct. 11, 2021 (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 the presentation of preclinical data supporting the potential of its broad-spectrum antifungal, ibrexafungerp, to treat mucormycosis. The data, based on an in vivo mouse model of mucormycosis, were presented at the 10th Trends in Medical Mycology (TIMM) meeting being held in-person in Aberdeen, Scotland, and virtually from October 8-11, 2021.
The study, conducted at The Lundquist Institute at Harbor-University of California at Los Angeles (UCLA) Medical Center, evaluated in a mouse model the potential of ibrexafungerp for the treatment of mucormycosis caused by Rhizopus delemar (the most common cause of mucormycosis) and found that ibrexafungerp monotherapy demonstrated survival benefits equivalent to current standard of care treatments, including liposomal amphotericin B and posaconazole. Additionally, the study found when ibrexafungerp was combined with amphotericin B, synergistic benefits were observed with a significant enhancement in median survival time and overall survival when compared to any one therapy alone.
“We are excited about the results of this study, which highlight ibrexafungerp’s broad-spectrum activity and potential to be an integral component of future treatment strategies for severe and invasive fungal infections,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “Mucormycosis is a rare, life-threatening fungal infection with limited treatment options. The rapid surge in mucormycosis cases seen in India among patients diagnosed with COVID-19, particularly among those with diabetes, underscores the urgency to identify novel therapeutics to combat the disease and help people around the globe suffering from this terrible, deadly fungal infection.”
Cases of mucormycosis have increased significantly during the COVID-19 pandemic and the Central Government of India declared mucormycosis an epidemic on May 10, 2021. More than 47,500 cases have been reported and over 4,400 deaths were attributed directly to this type of fungal infection in India in the three months between May 5, 2021, and August 3, 2021.1,2
“While the fungi that cause mucormycosis can be found in the environment and are harmless to most people, they can be deadly for those with weakened immune systems complicated by underlying conditions that have left them vulnerable to the infection,” said study lead author Ashraf Ibrahim, Ph.D., FAAM, FECMM, an Investigator at The Lundquist Institute and Professor of Medicine, David Geffen School of Medicine, UCLA. "I’m encouraged by the findings from this study which demonstrate the potential for a new antifungal class to treat mucormycosis. I believe this work lays a strong foundation for future studies evaluating ibrexafungerp’s potential to combat this often-lethal infection.”
The study was funded by the National Institutes of Health (NIH) utilizing the National Institute of Allergy and Infectious Diseases (NIAID) suite of preclinical services for in vivo testing. The presentation of findings, titled “Ibrexafungerp is effective in treating murine mucormycosis caused by Rhizopus delemar,” can be accessed by TIMM meeting attendees via the meeting’s online platform. More information on TIMM can be found here.
About Mucormycosis
Mucormycosis is an often life-threatening fungal infection that typically affects the nose, sinuses, eyes, and brain and is characterized by tissue necrosis and rapid progression.3 While multiple types of fungi can cause mucormycosis, R. delemar and R. oryae are the most common, accounting for ~70% of cases.4 Infections are most common in those with compromised immune systems, including those with cancer, diabetes or those taking steroid medications.1 The disease has an estimated 54% overall mortality rate.2
About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is 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 U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) on June 1, 2021. The FDA also granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV 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. Ibrexafungerp is formerly known as SCY-078.
About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS scientists are developing the company’s lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. SCYNEXIS has initiated the launch of its first commercial product in the U.S., BREXAFEMME® (ibrexafungerp tablets). The U.S. Food and Drug Administration (FDA) approved BREXAFEMME on June 1, 2021. In addition, late-stage clinical investigation of ibrexafungerp for the prevention of recurrent Vulvovaginal Candidiasis (VVC) and the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit www.scynexis.com.
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1 Akshay R, Nguyen TH, Rising incidence of mucormycosis in patients with COVID-19: another challenge for India amidst the second wave? Lancet, 2021 June, https://doi.org/10.1016/S2213-2600(21)00265-4 Accessed September 24, 2021.
2https://governmentstats.com/mucormycosis/index.html. Accessed October 1, 2021.
3 Hernández JL, Buckley CJ. Mucormycosis. 2021 Jul 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan–. PMID: 31335084. https://pubmed.ncbi.nlm.nih.gov/31335084/ Accessed September 24, 2021.
4 Ribes JA, Vanover-Sams CL, Baker DJ. Zygomycetes in human disease. Clin Microbiol Rev. 2000 Apr;13(2):236-301. doi: 10.1128/CMR.13.2.236. PMID: 10756000; PMCID: PMC100153. https://pubmed.ncbi.nlm.nih.gov/10756000/ Accessed September 24, 2021.
