SCYNEXIS Presents Data Supporting the Activity of its Lead Antifungal Drug Candidate SCY-078 Against Antifungal-resistant Candida Strains at the 13th ASM Conference on Candida and Candidiasis
JERSEY CITY, N.J., April 15, 2016 (GLOBE NEWSWIRE) -- Drug development company SCYNEXIS, Inc. (Nasdaq:SCYX) announced today that results of three nonclinical studies of the company’s lead clinical drug candidate, SCY-078, were presented at the 13th American Society for Microbiology (ASM) Conference on Candida and Candidiasis held in Seattle, WA.
The results of these in vitro microbiology studies of SCY-078, a novel glucan synthesis inhibitor currently in Phase 2 development as a treatment for invasive fungal infections, included the following:
- SCY-078 was active against more than 90% of fluconazole-resistant Candida spp. isolates. More than 200 individual strains (most of them C. glabrata) were included in this testing, conducted at three independent laboratories. We believe that this result suggests that SCY-078 is a promising orally bioavailable antifungal agent for the treatment of patients with fluconazole-resistant Candida spp. infections;
- Moreover, we believe that SCY-078 demonstrated superior activity as compared to caspofungin and micafungin against Candida glabrata isolates harboring fks mutations. Mutations in the fks genes are associated with decreased susceptibility to echinocandins. SCY-078 was active against 69% of the C.glabrata isolates with fks mutations whereas caspofungin and micafungin were active against 20% and 44% of the isolates, respectively. We believe that this data suggests that SCY-078 may be a suitable option for the treatment of infections caused by echinocandin-resistant C. glabrata strains.
- SCY-078 showed activity against 75% and 71% of multi-drug resistant (MDR) Candida albicans and glabrata strains, respectively. MDR was defined in this study as Candida strains resistant to both fluconazole and an echinocandin. We believe that this result suggests that SCY-078 may be a suitable option for the treatment of infections caused by azole- and echinocandin- resistant C. albicans and C. glabrata strains;
- We believe that these results are supportive of further development of SCY-078 for the treatment of invasive candidiasis, including those infections caused by azole- and echinocandin-resistant strains which are rapidly becoming a major public health problem.
“The nonclinical results presented at this year’s ASM Conference on Candida and Candidiasis support the potential broad clinical utility of SCY-078 against Candida infections, and offers hope for a new and efficacious oral and intravenous treatment option for these life threatening infections,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We believe that the need for a new class of anti-fungal agents is more apparent now than ever before as resistance continues to rise, and these results suggest that SCY-078 may prove useful in the fight against drug-resistant pathogens.”
- Note: In these experiments resistance to caspofungin, micafungin and fluconazole was determined according to the CLSI guidelines. Resistance to SCY-078 was defined as isolates having an MIC value ≥4-fold that of wildtype.
SCY-078 is an oral glucan synthase inhibitor in Phase 2 development for the treatment of fungal infections caused by Candida and Aspergillus species. SCY-078 is a semi-synthetic derivative of the natural product enfumafungin—a structurally distinct class of glucan synthase inhibitors. SCY-078 combines the well-established activity of glucan synthase inhibitors with the flexibility of use of azole with both oral and IV formulations. By belonging to a chemical class distinct from other antifungals, SCY-078 has shown in vitro activity against multi-drug resistant pathogens, including azole and echinocandin resistant strains. SCY-078 is currently in Phase 2 development with the oral formulations in two indications: invasive candidiasis and vulvovaginal candidiasis. The FDA designated SCY-078 as a QIDP for both oral and IV use for the indications of invasive candidiasis, including candidemia, and invasive aspergillosis.
About SCYNEXIS, Inc.
SCYNEXIS is a pharmaceutical company committed to the development and commercialization of novel anti-infectives to address significant unmet therapeutic needs. We are developing our lead product candidate, SCY-078, as an oral and IV drug for the treatment of several fungal infections, including serious and life-threatening invasive fungal infections in humans. For more information, visit www.scynexis.com.
Forward Looking Statement
Statements contained in this press release regarding matters that are expected to occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, any statements related to SCY078’s potential as an anti-fungal therapy. 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, risks inherent in SCYNEXIS' ability to successfully develop SCY-078, including SCYNEXIS' ability to 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 related to SCYNEXIS 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 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 April 15, 2016