Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has granted fast track designation for Scynexis' SCY-078, an oral glucan synthase inhibitor being developed to treat invasive Candidiasis, including Candidemia and invasive Aspergillosis.
Subscribe to our email newsletter
Currently, the company is screening patients for a Phase II trial of the oral formulation of SCY-078 and expects to enroll the first patient in the first quarter of 2015.
SCY-078 is a semi-synthetic derivative of the natural product enfumafungin, a structurally distinct class of glucan synthase inhibitors, which have been very effective in treating invasive fungal infections in a hospital setting, but are currently only available in intravenous formulations.
Being developed in both oral and intravenous formulations, SCY-078 has also been designated by the FDA as a Qualified Infectious Disease Product (QIDP) for oral use for the indications of invasive Candidiasis, including Candidemia, and invasive Aspergillosis.
SCYNEXIS president and chief executive officer Yves Ribeill said: "This Fast Track designation, coupled with our prior receipt of QIDP designation, allows for an accelerated path to approval and underscores the FDA’s understanding of the critical need for new and varied treatments for life-threatening invasive fungal infections.
"We now have multiple trial sites open and we look forward to reporting complete data in the first half of 2016."