- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Positive Mid-Stage Results Reported for Oral Antifungal Compound
VT-1161 treats vulvovaginal candidiasis (February 18)
Positive interim results have been reported from an ongoing phase II study of VT-1161 (Viamet Pharmaceuticals), an oral antifungal compound, in patients with moderate-to-severe acute vulvovaginal candidiasis (AVVC). The study is intended as a precursor to a phase IIb trial in patients with recurrent vulvovaginal candidiasis (RVVC).
VT-1161 is an inhibitor of the fungal metalloenzyme CYP51, the target of the current triazole antifungals. VT-1161, however, belongs to a new chemical class designed to provide superior efficacy compared with that of the triazole antifungals and to avoid many of the adverse effects that characterize those agents.
The AVVC study will enroll approximately 48 patients in three VT-1161 oral dose groups versus oral fluconazole, the current clinical standard-of-care for moderate-to-severe AVVC. In the initial portion of the study, patients were enrolled in a low-dose VT-1161 group, a mid-dose VT-1161 group, and a fluconazole control group. Both clinical and mycologic endpoints were evaluated on day 28. Effective clinical cure was based on an improvement in six clinical signs and symptoms of AVVC. Mycologic cure was defined as a negative fungal culture. Effective therapeutic cure was defined as both effective clinical cure and mycologic cure.
The results of the interim analysis support the antifungal activity of VT-1161. In the intent-to-treat population (all randomized patients who received at least one dose of study drug), effective therapeutic cure was achieved in 71% of patients in the low-dose VT-1161 arm, in 92% of patients in the mid-dose VT-1161 arm, and in 80% of patients in the fluconazole arm.
VT-1161 was also found to be well tolerated. No serious adverse events were reported, and no patients discontinued VT-1161 because of an adverse event. Based on the drug’s favorable safety and tolerability profile, an additional high-dose cohort is currently being enrolled. Results from this final patient cohort are expected in the second quarter of 2014.
Source: Viamet Pharmaceuticals; February 18, 2014.