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news.SCYNEXIS has started a phase 1 clinical trial to study the intravenous (IV) formulation of its novel antifungal drug candidate SCY-078.
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SCY-078 is being developed as both an oral and IV formulation to treat invasive and life-threatening fungal infections including candidemia and invasive aspergillosis.
The study will assess the safety, tolerability and pharmacokinetics of single-rising IV doses of SCY-078 in about 36 male and female subjects.
The company said SCY-078 is a semi-synthetic derivative of enfumafungin, a structurally distinct class of glucan synthase inhibitors.
In in-vitro studies, SCY-078 demonstrated to have activity against the important fungal pathogens, Candida and Aspergillus spp., including those resistant to azoles and/or echinocandins.
The drug is fungicidal for candida and works by inhibiting beta 1,3 D glucan synthesis in the cell wall of fungi, leading to cell death.
SCYNEXIS president and CEO Marco Taglietti said: "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.
"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."