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Head Lice

September 8, 2014

Hatchtech issued positive results from two phase III studies evaluating Xeglyze Lotion (formerly DeOvo Lotion) for head lice infestation. The two phase III studies, enrolling 704 subjects across 14 clinical study sites in the U.S., were double-blind, randomized, multi-center, vehicle-controlled, parallel-groups and treated subjects with an active head lice infestation aged six months and older. The phase III studies demonstrated that a single, ten-minute application of Xeglyze Lotion resulted in a statistically significant increase in the proportion of subjects who were cleared of lice compared with the vehicle lotion. They showed 81.5% of patients who received only one application of Xeglyze Lotion and without nitcombing remained lice free at all follow-up visits through to the day 14 visit, which was the primary efficacy endpoint. The studies showed 90% of subjects were lice-free after just one day following treatment with Xeglyze Lotion, and 88% were lice-free after seven days. The company remains on track to file an NDA with the FDA in the first half of 2015.

December 26, 2011

Hatchtech released results from a phase IIb trial of DeOvo topical treatment for head lice. This double blind, randomized trial, Ha02-003, enrolled 140 subjects, ages two years and older, with head lice infestation. The subjects received a single 10-minute treatment with DeOvo (0.74% w/v or 0.37% w/v) or placebo. The primary endpoint was the proportion of all subjects who are lice free at all follow-up visits through the Day 14 visit. The primary efficacy results demonstrated a statistically significant (p<0.001) and clinically relevant outcome in both the DeOvo treatment groups (85.7% and 67.4% treatment success in the high and low dose arm, respectively) compared to the placebo group (23.4% treatment success). No serious adverse events were reported.