SCYNEXIS Presents Data Supporting the Potential Clinical Utility of Antifungal Drug Candidate at ICAAC/ICC 2015
Provides Update of SCY-078 Clinical Program at Mycoses Study Group Education and Research Consortium 2015 Annual Meeting
JERSEY CITY, N.J., Sept. 21, 2015 (GLOBE NEWSWIRE) -- Drug discovery and 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 in podium and poster presentations at the 55th Annual Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and the International Congress of Chemotherapy (ICC) joint meeting in San Diego, California.
The results of the nonclinical studies of SCY-078, a novel glucan synthesis inhibitor currently in Phase 2 development as a treatment for invasive fungal infections, included the following:
- Intravenous administration of SCY-078 in preclinical models resulted in plasma exposures that exceeded by 16-fold those associated with efficacy in murine models of invasive candidiasis;
- SCY-078 was well-tolerated when delivered intravenously in multiple species and showed low plasma clearance and high volume of distribution in tissues;
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SCY-078 distributes extensively to key tissues commonly associated with invasive fungal infections:
- Extensive distribution in lung epithelial lining fluid, with concentrations ~ 5 fold greater than in plasma,
- Kidney exposure >20-fold the exposure measured in paired plasma samples indicating marked distribution into this tissue,
- Result are supportive of further development of SCY-078 for the treatment if invasive fungal infections
Additionally, an update on the ongoing Phase 2 study of SCY-078 as step-down therapy in invasive candidiasis was presented at the Mycoses Study Group Education and Research Consortium (MSGERC) 2015 Annual Meeting.
"These nonclinical results presented at ICAAC support the broad clinical utility and promise of SCY-078 as a potential effective new treatment option for patients and clinicians," said Marco Taglietti, M.D., SCYNEXIS' Chief Executive Officer. "Moreover, as reported at the MSGERC 2015 Annual Meeting, our Phase 2 study in invasive candidiasis is in progress and with the amendments to the Phase 2 study protocol now in place and the expansion of the study to new sites in Latin America, we continue to anticipate top-line results in first half of 2016."
About SCY-078
SCY-078 is an oral glucan synthase inhibitor in Phase II being developed for the treatment of invasive fungal infections including Candidemia and invasive Aspergillosis. SCY-078 is a semi-synthetic derivative of the natural product enfumafungin—a structurally distinct class of glucan synthase inhibitors. Glucan synthase inhibitors have been very effective in treating invasive fungal infections in a hospital setting, but are currently only available in intravenous formulations. The FDA designated SCY-078 as a Qualified Infectious Disease Product (QIDP) and has granted Fast Track status for oral use for the indications of invasive Candidiasis, including Candidemia, and invasive Aspergillosis. SCYNEXIS is developing both oral and intravenous formulations of SCY-078.
About SCYNEXIS, Inc.
SCYNEXIS is a pharmaceutical company committed to the discovery, development and commercialization of novel anti-infectives to address significant unmet therapeutic needs. We are developing our lead product candidate, SCY-078, a novel antifungal in Phase 2, as an oral and intravenous (IV) drug for the treatment of 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 not historical facts, including any future clinical trials, future performance of product candidates, the potential of SCY-078 to treat invasive fungal infections, the therapeutic and commercial potential of SCY-078, and the anticipated timing of clinical trials and therapeutic and commercial potential of SCY-078 are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results and the timing of these events, including regarding the further development of SCY-078, could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of SCYNEXIS's product development activities, including any current and future clinical trials of SCY-078; any delays or inability to obtain or maintain regulatory approval of product candidates in the United States or worldwide; the company's ability to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide; and the market potential for the company's product candidates. Risks are described more fully in SCYNEXIS'S filings with the Securities and Exchange Commission, including without limitation its most recent Quarterly Report on Form 10-Q 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.
CONTACT: Media Relations
Heather Savelle
MacDougall Biomedical Communications
Tel: 781-235-3060
hsavelle@macbiocom.com
Investor Relations
Susan Kim
Argot Partners
Tel: 212-203-4433
susan@argotpartners.com
Released September 21, 2015