August 22, 2016
NovaDigm Therapeutics reported
results of a phase IIa study of NDV-3A for
recurrent vulvovaginal candidiasis (RVVC).
The multicenter, double-blind, randomized,
placebo-controlled study enrolled 188 patients
over 20 U.S. study sites. Patients were
assigned one dose of either 300μg NDV-3A
immunotherapy or a placebo. The study met
its primary endpoint of safety and tolerability.
There were no significant differences
between NDV-3A and placebo for injection
site reactions and systemic reactions of
grade three or greater. A single dose of NDV-
3A generated very rapid and robust immune
responses. Exploratory efficacy measures
based on patient-reported symptom scores
showed a trend toward significance at the
12-month follow-up period (p=0.10). Younger
patients showed higher efficacy rates. In
patients under 40 years of age (80% of the
study population), NDV-3A recipients were
about 50% more likely to be recurrence free
at the end of the study compared to placebo
August 8, 2016
SCYNEXIS issues results of an interim analysis of its phase II study evaluating SCY-078 as an oral step-down treatment in patients initially treated with intravenous (IV) echinocandin therapy for invasive Candida infections. In this multicenter, multinational, randomized, open-label trial following three to 10 days of IV echinocandin therapy, 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 (seven patients), SCY-078 750mg QD with a 1,250mg loading dose (seven patients) or standard-of-care (seven patients receiving fluconazole 400mg QD with a 800mg loading dose and one patient receiving micafungin IV 100mg QD because of a fluconazole-resistant isolate) for up to 28 days. Data in the interim analysis includes assessments conducted in the 22 randomized patients (ITT population) up to the end of treatment visit. SCY-078 was safe and well-tolerated, achieving the additional primary study objective. The frequency of adverse events (AEs) was similar among all treatment groups. The most commonly reported AEs in the study were gastrointestinal (GI), such as diarrhea, abdominal pain, nausea and vomiting. Two of the seven patients treated with 750mg of SCY-078 reported GI events (29%), compared to three of the seven patients treated with fluconazole (43%). All GI events were mild or moderate and none resulted in discontinuation. The company intends to initiate subsequent studies of SCY-078 as an IV/oral step-down therapy in patients with refractory invasive fungal infections by the end of 2016 and with invasive candidiasis in the first quarter of 2017.
February 14, 2005
Vicuron Pharmaceuticals reported positive results of a phase III trial of anidulafungin, for the treatment of hospital acquired candidiasis/candidemia. Study data exceeded their primary endpoint of non-inferiority, establishing statistically superior global response in the intent-to-treat population vs. standard therapy with fluconazole at the end of treatment (75.6%, n=96/127 vs. 60.2%, n=71/118; p<0.05). Secondary endpoints were also met, with superiority established in global response at 2 week follow-up (64.6%, n=82/127, vs. 49.2%, n=58/118), and non-inferiority established in global response at 6 week follow-up (55.9%, n=71/127, vs. 44.1%, n=52/118). This randomized, double-blind, multi-center study enrolled 256 subjects with invasive candidiasis/candidemia, who received daily doses of either 100 mg anidulafungin or 400 mg fluconazole for 10-42 days. Based on these results, the company announced plans to amend their pending NDA for esophageal candidiasis in Q2 2005, and file an NDA for the drug for invasive candidiasis/candidemia in Q3 2005.