SCYNEXIS Announces Preclinical Data on Ibrexafungerp and Azoles against Aspergillus Presented at the 9th Advances Against Aspergillosis and Mucormycosis Conference
- Preclinical in vitro data showed synergistic activity against Aspergillus isolates from lung transplant recipients
- SCYNEXIS is conducting two clinical trials for patients suffering from Aspergillus infections: FURI evaluating ibrexafungerp as salvage therapy (alone or in combination) and SCYNERGIA evaluating ibrexafungerp as first-line therapy in combination with an azole
JERSEY CITY, N.J., March 05, 2020 (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 that data from a preclinical study of oral ibrexafungerp in combination with azoles against Aspergillus species isolated from lung transplant recipients were presented at the 9th Advances Against Aspergillosis and Mucormycosis conference on February 27-29, 2020. These in vitro data showed synergistic activity of ibrexafungerp in combination with azoles against Aspergillus isolates. Ibrexafungerp is a broad-spectrum, IV/oral antifungal agent representing a novel therapeutic class, in late stage development for multiple indications, ranging from vaginal yeast infections to life-threatening fungal infections, including invasive aspergillosis.
“Aspergillus is a common mold that can be deadly for patients with weak immune systems due to chemotherapy or transplants. Despite prophylaxis and treatment with the current standard of care, including azole therapies, the mortality rate among lung transplant patients remains high and will only grow as drug-resistant strains continue to emerge. It is imperative that we develop new weapons to use in the fight against invasive fungal infections, including aspergillosis,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. “The data presented here strengthens our conviction that ibrexafungerp, as part of a combination regimen with azole agents, could play a role in combating Aspergillus infections. We are conducting multiple clinical trials evaluating ibrexafungerp for the treatment of invasive aspergillosis and other life-threatening fungal pathogens.”
The preclinical study evaluated the in vitro activity of ibrexafungerp, alone or in combination with current azole treatments, against 51 Aspergillus isolates recovered from lung transplant recipients. It demonstrated synergistic activity against the majority of isolates tested, with no antagonistic activity seen when ibrexafungerp was used in combination with current azole-based treatments. The effect of ibrexafungerp on improving azole susceptibility for azole-resistant strains of Aspergillus calidoustus and Aspergillus terreus was particularly noteworthy. These results further confirm ibrexafungerp’s potential use in combination with current treatment options for patients suffering from invasive aspergillosis. For more details on the study, visit https://aaam2020.org/programme/.
Aspergillosis is a serious infection caused by Aspergillus, a common mold ubiquitously present in the environment. In healthy individuals Aspergillus is generally not harmful, however for patients with compromised immune systems, such as those receiving chemotherapy or organ transplants, Aspergillus can result in a dangerous and life-threatening infection called invasive aspergillosis (IA). Symptoms of IA can include fever, chills, shortness of breath, chest pains, headaches and skin lesions.
Current treatment guidelines recommend the use of azoles as the initial first-line therapy; however, patients face unsatisfactory clinical outcomes, with mortality rates up to 50%. In addition to azoles, echinocandins can be used to treat IA; however, echinocandins can only be administered through IV and are not optimal for the weeks or months necessary to effectively combat IA. As a result of the rise of resistant strains, some countries are using a combination of antifungals as first-line treatment for patients suspected of IA.
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, the 'fungerps'. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and IV formulations. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. 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 granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), invasive aspergillosis (IA) and vulvovaginal candidiasis (VVC) and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of people worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. Our lead candidate, ibrexafungerp (formerly known as SCY-078), is a broad-spectrum, IV/oral antifungal agent representing a novel therapeutic class, in late stage development for multiple indications, ranging from vaginal yeast infections to life-threatening fungal infections in hospitalized patients. The SCYNEXIS team has deep expertise in anti-infective drug development and marketing, which can be leveraged to advance ibrexafungerp from clinical development to commercialization. For more information, visit www.scynexis.com.
Forward Looking Statement
Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: risks inherent in SCYNEXIS's ability to successfully develop and obtain FDA approval for ibrexafungerp; the expected costs of studies and when they might begin or be concluded; and SCYNEXIS's reliance on third parties to conduct SCYNEXIS's clinical studies. These and other risks are described more fully in SCYNEXIS's filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K under the caption "Risk Factors" and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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Released March 5, 2020