Date: 2016-10-05
Type of
information: Results
phase: 2
Announcement: results
Company: Scynexis (USA - NJ)
Product: SCY-078 ((1,3)-ß-D-glucan synthesis inhibitor)
Action
mechanism:
- enzyme inhibitor/glucan synthase inhibitor. SCY-078 is an oral and IV glucan synthase inhibitor in Phase 2 clinical development for the treatment for fungal infections caused by Candida and Aspergillus species. SCY-078 is a semi-synthetic triterpene derivative of the natural product enfumafungin—a structurally distinct class of glucan synthase inhibitor. By belonging to a chemical class distinct from other antifungals, SCY-078 has shown in vitro and in vivo activity against multi-drug resistant pathogens, including azole and echinocandin resistant strains. The FDAgranted Fast Track, Qualified Infectious Disease Product (QIDP) and orphan drug designations (ODD) for the oral and IV formulations of SCY-078 for the indications of invasive Candida infections (including candidemia) and invasive Aspergillus infections.
Disease: invasive candidiasis
Therapeutic
area: Infectious diseases
Country: El Salvador, Germany, Guatemala, Honduras, USA
Trial
details:
- The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis. A total of 27 patients with invasive candidiasis were enrolled and 22 were randomized to receive either SCY-078 500mg QD with a 1,000mg loading dose (7 patients), SCY-078 750mg QD with a 1,250mg loading dose (7 patients) or standard of care (7 patients receiving fluconazole 400mg QD with a 800mg loading dose and 1 patient receiving micafungin IV 100mg QD due to a Candida glabrata with decreased fluconazole-susceptibility for up to 28 days). Efficacy was assessed based on achievement of favorable global response defined as the resolution of signs and symptoms attributable to the Candida infection and mycological eradication without the use of any other antifungal agent. Patients were followed for six weeks after the end of treatment. (NCT02244606)
Latest
news:
- • On October 5, 2016, Scynexis announced the complete results of its recently completed Phase 2 study of oral SCY-078 in patients with invasive candidiasis. The study evaluated the pharmacokinetics (PK), safety, and tolerability of SCY-078 as an oral step-down treatment in patients initially treated with intravenous (IV) echinocandin therapy for invasive Candida infections. Twenty-two patients were randomized to receive study drug or standard of care (one of the patients randomized to standard of care could not receive oral fluconazole due to a Candida glabrata with decreased fluconazole-susceptibility and received micafungin for the entire duration of antifungal therapy). As previously reported, the study met its primary objective by confirming the once daily oral dose of SCY-078 750mg as a dose that is both overall safe and tolerated and achieves the target exposure in these patients. During the study period, there were no reports of mycological failures in the SCY-078 750mg group (n=7) versus two infection-related failures (one fungemia and one abdominal sepsis) in the fluconazole group (n=7). No relapses were observed in these two groups during the six-week follow-up period.
As previously reported, SCY-078 was overall safe and tolerated in both studies. There were no discontinuations due to adverse events (AEs) and no related serious AEs. Consistent with previous findings, the most common AEs were mild to moderate gastrointestinal (GI) events such as diarrhea nausea, vomiting, abdominal pain or discomfort. In patients with invasive candidiasis, the number of GI events were comparable in both the SCY-078 and fluconazole treatment arms.
Is
general: Yes
