An investigative oral agent, VT-1161, appears to restore nails with moderate-to-severe fungus infection to their normal state, according to results of a phase 2b study presented here at the 2017 Annual Meeting of the American Academy of Dermatology (AAD).
"This study shows strong evidence of clinical and mycologic efficacy...through week 60," said Amir Tavakkol, PhD, Viamet Pharmaceuticals, Durham, North Carolina.
The study included 259 patients diagnosed with 25% to 75% of toenail involvement with distal-lateral subungual onychomycosis. Patients received low-dose (300 mg) VT-1161 and high-dose VT-1161 (600 mg) for 12 weeks and 24 weeks. Another group was administered placebo alone.
The primary endpoint was complete cure of the target toenail at week 48 -- a composite endpoint requiring a 100% clear nail with negative culture and negative potassium hydroxide test.
After 48 weeks in the intent-to-treat populations, results demonstrated the following:
- 32% of 53 patients in the low-dose group treated for 12 weeks achieved completely clear toenails.
- 38% of 52 patients in the low-dose group treated for 24 weeks achieved completely clear toenails.
- 42% of 53 patients in the high-dose group treated for 12 weeks achieved completely clear toenails.
- 33% of 54 patients in the high-dose group treated for 24 weeks achieved completely clear toenails.
None of the 47 patients treated with placebo for 24 weeks achieved completely clear toenails (P < .001 vs placebo across all arms).
"At all doses, VT-1161 was safe and well tolerated, with no evidence of an adverse effect on liver function," said Dr. Tavakkol.
Long half-life makes oral VT-1161 suitable to once-weekly dosing. Phase 3 studies are planned for 2017.
Funding for this study was provided by Viamet Pharmaceuticals, Durham, North Carolina.
[Presentation title: Positive Efficacy and Safety Outcomes From a Randomized, Double-Blind, Placebo-Controlled Phase 2b Study of Four Oral VT-1161 Regimens in the Treatment of Patients With Moderate-Severe Distal-Lateral Subungual Onychomycosis (DLSO). Abstract 5221]