JERSEY CITY, N.J., Nov. 12, 2015 (GLOBE NEWSWIRE) -- Drug development company SCYNEXIS, Inc. (Nasdaq:SCYX) today announced the initiation of a Phase 1 clinical trial to study the intravenous (IV) formulation of SCY-078. SCYNEXIS' novel antifungal drug candidate SCY-078 is in development as both an oral and IV formulation for the treatment of invasive and life-threatening fungal infections. The study will evaluate the safety, tolerability and pharmacokinetics of single-rising IV doses of SCY-078 in healthy subjects.
"SCY-078 has the potential to address key unmet needs in the treatment of invasive fungal infections, and this important milestone in its development represents good news for infectious disease physicians and their patients," said Dr. Peter Pappas, Principal Investigator of the Mycoses Study Group and Professor of Infectious Diseases at the University of Alabama School of Medicine. "The availability of SCY-078 in both IV and oral formulations will provide the opportunity of starting antifungal therapy with this agent in critically ill patients with the IV formulation and stepping-down to oral therapy with a glucan synthase inhibitor agent, which is currently not an available option."
"The initiation of our Phase 1 study of the IV formulation of SCY-078, our first-in-class antifungal candidate, represents a significant event for our company as we move closer to our objective of developing the very first glucan synthase inhibitor that could be administered both orally and intravenously," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS, Inc. "In addition, the potential to provide an IV formulation of this treatment could significantly expand the range of indications for which SCY-078 may be a suitable treatment option."
About the Study
The Phase 1 study is a randomized, placebo-controlled, alternating-panel, single-rising IV dose study of SCY-078 in healthy subjects. Approximately 36 male and female subjects will be assigned to one of four panels with each group receiving up to four different IV or oral doses of SCY-078 at staggered time periods. The study will evaluate the safety and tolerability of IV doses of SCY-078 and provide plasma pharmacokinetic data.
SCY-078 (formerly MK-3118) is an oral glucan synthase inhibitor in Phase 2 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 IV formulations. The FDA designated SCY-078 as a Qualified Infectious Disease Product (QIDP) for oral use for the indications of invasive Candidiasis, including Candidemia, and invasive Aspergillosis. SCY-078 has been shown in in vitro studies to have activity against the key fungal pathogens, Candida and Aspergillus spp., including those resistant to azoles and/or echinocandins. SCYNEXIS is developing both oral and IV formulations of SCY-078.
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 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 the future performance of SCYNEXIS's product candidates, the potential of SCY-078 to treat invasive fungal infections, and the therapeutic and commercial potential of SCY-078, 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. Risks and uncertainties include: regulatory risks; and the risk that results in prior trials may not be repeated in subsequent trials. 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 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.
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