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 recipients (p<0.05).

March 21, 2016

Viamet Pharmaceuticals reported positive results from a planned interim analysis of REVIVE, its ongoing phase IIb trial of VT-1161 for the treatment of recurrent vulvovaginal candidiasis (RVVC). REVIVE is a randomized, double-blind, placebo-controlled, 48-week clinical trial of VT-1161 in patients with RVVC. The trial is evaluating two dose levels of VT-1161 administered once weekly for either 11 or 23 weeks, following an initial one-week daily loading dose period in each. At baseline, the mean number of AVVC episodes per patient in the prior 12 months ranged from 4.5 to 6 across the study arms. The trial enrolled 215 patients at 32 sites throughout the U.S. A planned interim analysis was conducted when approximately 100 patients had completed the first 24 weeks of the trial. Across the four VT-1161 treatment arms, only 3% of the patients suffered a recurrence of AVVC through week 24 as compared to 48% of patients in the placebo arm. Notably, in the two high-dose VT-1161 arms there was not a single patient who suffered a recurrence through week 24. In addition, safety data from the interim analysis population demonstrated that VT-1161 was well tolerated with a favorable safety profile. In particular, there was no evidence of an adverse effect of VT-1161 on liver function. Top-line final results are expected in the fourth quarter of 2016.

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.

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