SCY-078 may provide a therapeutic option for this emerging pathogen classified as a serious global health threat by the CDC
Multiple studies confirm SCY-078's broad spectrum of activity against Candida species, including resistant strains
JERSEY CITY, N.J., May 11, 2017 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, today announced the publication of results of a broad systematic study of the activity of SCY-078 against Candida auris, an emerging life-threatening and multidrug-resistant fungus, in the Antimicrobial Agents and Chemotherapy (AAC) medical journal. In this study, the Mycotic Diseases Branch of the CDC showed that SCY-078, the first representative of a novel intravenous (IV)/oral triterpenoid antifungal family, has activity in vitro against C. auris, confirming SCY-078's broad spectrum of activity. These results further build on the evidence previously reported by Case Western Reserve University School of Medicine and recently published in AAC regarding the potential for SCY-078 to be active in the treatment of infections caused by this multidrug-resistant pathogen.
CDC Study Results
In this study, researchers evaluated the in vitro activity of SCY-078 against a collection of 100 C. auris isolates representing each of the four known clades of the pathogen and originating from countries all over the world, including India, Pakistan, Colombia, South Africa, and the U.S. SCY-078 showed potent activity against all strains at concentrations indicative of a potentially clinically-relevant effect. Additionally, the study showed that SCY-078 retained activity against echinocandin-resistant C. auris isolates, illustrating that resistance to other glucan synthase inhibitors (echinocandin class) was not indicative of resistance to SCY-078.
"Candida auris is an emerging global health threat with an estimated mortality rate of approximately 60%," said David Angulo, M.D., Chief Medical Officer at SCYNEXIS. "Some C. auris strains have been reported to be resistant to drugs from all commercially available antifungal classes, underlining the urgent need for effective new therapies as patients are left without efficacious treatment options. These initial results are extremely encouraging and highlight the potential of SCY-078 to address this growing public health crisis. We look forward to continuing to accelerate the development of this promising therapy."
Case Western Reserve University School of Medicine Study Results
The CDC results reconfirm results published in February by researchers at Case Western Reserve University School of Medicine who evaluated the activity of SCY-078 and ten currently available antifungal agents against 16 different C. auris isolates to determine the susceptibility of the isolates to these fungal classes. While most of the assessed strains in this study proved to be resistant to multiple drugs tested, SCY-078 showed potent activity against all strains at the concentrations tested. Additionally, results showed that SCY-078 reduced biofilms and biofilm metabolic activity at all concentrations tested, a notable feature given C. auris infections have been frequently associated with IV catheter use.
"These results, taken together, provide further evidence of the effect SCY-078 may have in the treatment of C. auris infections, as well as its ability to address other difficult-to-treat infections in the broader Candida class," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "This study clearly demonstrates SCY-078's unique broad spectrum antifungal activity, a major differentiator over other available treatments. We believe the key attributes of SCY-078, including its broad spectrum, activity against resistant strains, formulation versatility, high tissue distribution, fungicidal activity and favorable safety profile, will enable the drug to have a therapeutic effect in a broad variety of serious fungal infections."
About Candida auris
Candida auris, a fungal strain first reported in 2009, has been linked to invasive fungal infections in nine countries, including the U.S., and has caused at least two hospital outbreaks involving more than 30 patients each. The CDC estimates that infections with C. auris are associated with a mortality rate of approximately 60% and that some strains of this species of Candida have proven to be resistant to all three major classes of antifungal drugs, rendering treatment difficult. This type of broad resistance to approved antifungal agents has not been observed in other species of Candida. The most common type of infection caused by C. auris is in the bloodstream. The CDC is actively tracking C. auris infections globally and has issued an alert to all healthcare facilities classifying this new pathogen as a serious global health threat.
SCY-078 is an oral and IV antifungal agent in Phase 2 clinical development for the treatment of fungal infections caused by Candida and Aspergillus species. SCY-078 is a triterpenoid, semi-synthetic derivative of the natural product enfumafungin—a structurally distinct and novel class of glucan synthase inhibitor. SCY-078 combines the well-established activity of glucan synthase inhibitors (similar to echinocandins) with the potential flexibility of having IV and oral formulations (similar to azoles). By belonging to a chemical class distinct from other antifungals, SCY-078 has shown in vitro and in vivo activity against multi-drug resistant pathogens, including azole- and echinocandin-resistant strains. The U.S. Food and Drug Administration granted Fast Track, Qualified Infectious Disease Product and Orphan Drug Designations for the oral and IV formulations of SCY-078 for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis.
SCYNEXIS, Inc. is a biotechnology company committed to positively impacting the lives of patients suffering from difficult-to-treat and often life-threatening infections by delivering innovative anti-infective therapies. The SCYNEXIS team has extensive experience in the life sciences industry, discovering and developing more than 30 innovative medicines over a broad range of therapeutic areas. The Company's lead product candidate, SCY-078, is the first representative of a novel intravenous and oral triterpenoid antifungal family and is in Phase 2 clinical development for the treatment of several fungal infections, including serious and life-threatening invasive fungal infections. For more information, visit www.scynexis.com.
Forward Looking Statement
Statements contained in this press release maybe, "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' ability to successfully develop SCY-078, including SCYNEXIS' ability to resolve the FDA's concerns to lift the clinical hold on the IV formulation of SCY-078 on a timely basis, if at all, and obtain FDA approval for SCY-078; the expected costs of studies and when they might begin or be concluded; and SCYNEXIS' reliance on third parties to conduct SCYNEXIS' clinical studies. These and other risks are described more fully in SCYNEXIS' 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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