JERSEY CITY, N.J., May 08, 2017 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, today reported financial results for the quarter ended March 31, 2017, and provided an update on recent operational and clinical developments.
SCY-078 Update
Clinical Development Status of IV Formulation of SCY-078
- We recently met with the FDA to discuss the requirements needed to lift the clinical hold on the intravenous (IV) formulation of SCY-078. Based on the feedback from this meeting, we plan to submit to the FDA a comprehensive analysis of data from preclinical and clinical studies, including recently completed and planned preclinical studies. Upon lifting of the clinical hold, we plan to test the intended IV dose regimen first in healthy volunteers and then expect to initiate our planned Phase 2 study for the treatment of patients with invasive Candida infections. As a result, we now anticipate the commencement of this Phase 2 study to occur in 2018.
Clinical Development Program with Oral Formulation of SCY-078 On Track
- Clinical development of the oral formulation of SCY-078 is progressing as planned. We have opened sites in the U.S. for the open-label study of oral SCY-078 for the treatment of invasive fungal infections that are refractory to or intolerant of standard antifungal agents (FURI study). We expect enrollment in this study to commence in the second quarter of 2017.
Eight SCY-078 Data Presentations at ECCMID
- In April 2017, we had several clinical and non-clinical presentations at the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) that supported the broad spectrum activity of SCY-078 against fungal infections in multiple settings and indications. Key conclusions presented include:
- Synergy of SCY-078 in combination with other antifungals against Aspergillus
- Antifungal activity of SCY-078 against emerging drug-resistant Candida auris
- Activity of SCY-078 against Candida biofilms
- Clinical efficacy in two Phase 2a studies in patients with invasive candidiasis and patients with vulvovaginal candidiasis (VVC)
