SCYNEXIS to Present Pre-clinical Data Supporting Prophylactic Use of Ibrexafungerp at Superbugs and Superdrugs 2019
Oral ibrexafungerp demonstrates potent antifungal activity against Pneumocystis in vivo
Ibrexafungerp's broad spectrum activity and flexibility of oral administration highlight its potential utility as a prophylactic agent for immunocompromised patients
JERSEY CITY, N.J., Feb. 28, 2019 /PRNewswire/ -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced that the Company will present new in vivo data supporting the potential use of oral ibrexafungerp (formerly SCY-078) for the prevention and treatment of Pneumocystis pneumonia (PCP), a significant risk for immunocompromised patients. The presentation will take place on March 18th at 4PM GMT at Superbugs and Superdrugs 2019, March 18-20, 2019, in London. Ibrexafungerp, the first representative of a novel antifungal family referred to as triterpenoids, is being developed for oral and intravenous (IV) administration and is in clinical development for the treatment of several serious fungal infections, including vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections.
The oral presentation, entitled: "Activity of oral ibrexafungerp in murine models of Pneumocystis pneumonia," will be delivered by Stephen A. Barat, Ph.D., Vice President, Pre-clinical Research and Early Clinical Development at SCYNEXIS. The presentation highlights the results from multiple animal studies that evaluated oral ibrexafungerp versus both trimethoprim/sulfamethoxazole, which is the current standard of care for PCP, and vehicle control. Oral ibrexafungerp demonstrated strong activity against PCP in this model, as determined by a reduction in organism burden and improved survival. These results support future investigation of ibrexafungerp for both the prevention and treatment of PCP.
"Pneumocystis pneumonia is a potentially life-threatening infection that occurs in vulnerable immunocompromised individuals, including those undergoing solid organ and stem cell transplants, where prevention of these infections is critically important to patient health," said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. "Currently, these patients receive a two-drug prophylactic regimen comprised of an azole agent to prevent Candida and Aspergillus infections, and trimethoprim/sulfamethoxazole to prevent Pneumocystis infection. Ibrexafungerp, with broad spectrum activity against Candida, Aspergillus and Pneumocystis, could be a transformative prophylaxis option, providing a single oral agent for the prevention of the most common fungal infections in these immunocompromised patients. Following the positive interim results from our Phase 3 open-label FURI study, which demonstrated oral ibrexafungerp's ability to treat refractory fungal infections, these additional pre-clinical findings further validate our vision of maximizing the potential clinical utility of this novel antifungal across multiple indications."
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, 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 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 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 committed to positively impacting the lives of patients suffering from difficult-to-treat and often life-threatening infections by developing innovative therapies. The SCYNEXIS team has extensive experience in the life sciences industry, having discovered and developed more than 30 innovative medicines over a broad range of therapeutic areas. SCYNEXIS's lead product candidate, ibrexafungerp (formerly known as SCY-078), is a novel IV/oral antifungal agent in Phase 3 clinical and preclinical development for the treatment of multiple serious and life-threatening invasive fungal infections caused by Candida and Aspergillus species. 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; whether the positive results from the FURI trial to date will continue to be achieved as the study continues; uncertainties about the regulatory standards for approval through LPAD; 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.
George E. MacDougall
MacDougall Biomedical Communications
SOURCE SCYNEXIS, Inc.
Released February 28, 2019