We developed an IV formulation of SCY-078 and are enrolling healthy volunteers in a single ascending dose Phase 1 study. We expect to complete the study and report results in the second quarter of 2016;
We initiated enrollment of a multicenter Phase 2 study with primary endpoints of safety and efficacy of the oral formulation of SCY-078 in patients with VVC in the fourth quarter of 2015. We expect to complete the study and report top line data in the second quarter of 2016;
We continue to enroll patients in the Phase 2 study with primary endpoints of safety, tolerability, and pharmacokinetics of the oral formulation of SCY-078 as step-down treatment in patients initially treated with echinocandin therapy for invasive Candida infections. We have opened new investigational sites in the U.S. and in Latin America and we are in the process of opening more sites in these regions and in Europe. Based on the data collected on the enrolled patients, together with the data from our recently completed Phase 1 biocomparison study, we expect to achieve the primary objectives of the study with fewer patients than originally planned. We expect to report top line data by the end of the second quarter of 2016;
We completed a Phase 1 biocomparison study of a new, well-tolerated citrate salt formulation of SCY-078 that has a comparable pharmacokinetic profile and potential formulation advantages over the previously used phosphate salt formulation. This new formulation will be used in development of both the oral and IV formulations going forward, and has the potential to extend composition of matter patent protection up to 2035; and
We secured Fast Track and Qualified Infectious Disease Product designations from the U.S. Food and Drug Administration for the IV formulation of SCY-078 in both invasive candidiasis and invasive aspergillosis.