Mode of action
Hatchtech research has identified that a specific group of enzymes known as metalloproteinases are involved in insect egg hatching and survival. Hatchtech has subsequently discovered specific compounds that are able to disrupt these processes through their ability to inhibit these enzymes. It is one of these metalloproteinase inhibiting compounds that is the active ingredient in DeOvo™, recently renamed as Xeglyze™ Lotion.
A substantial body of scientific data has established the mode of action of Xeglyze™. Additionally, the company has conducted a rigorous nonclinical safety program, and completed four Phase 1, five Phase 2 and two Phase 3 clinical studies to evaluate the safety and efficacy Xeglyze™.
Hatchtech recently completed its two pivotal Phase 3 clinical studies evaluating Xeglyze™ Lotion (formerly DeOvo Lotion) as a potential treatment for head lice infestation. Both studies achieved the pre-defined primary and secondary endpoints and were conducted under a U.S. Investigational Drug Application (IND) according to a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).
Hatchtech conducted two Phase 3 studies, enrolling a total of 704 subjects across 14 clinical study sites in the United States. The studies were double-blind, randomised, multicentre, vehicle-controlled, parallel-group and treated subjects with an active head lice infestation aged six months and older. The studies were designed to assess the efficacy, safety and tolerability of a single application of Xeglyze™ Lotion compared to a vehicle lotion, when applied to the scalp and hair for ten minutes at home. The results were assessed in follow-up visits to the clinical study sites 1, 7 and 14 days following application.
The primary efficacy endpoint as agreed with the FDA was the percentage of patients who remained lice-free at all follow-up visits through to the day 14 visit after one application of Xeglyze™ Lotion. The secondary efficacy endpoint was the proportion of subjects who were lice-free at the Day 1 visit and the Day 7 visit.
Expressions of interest of a Business Development nature should be directed to the CEO.
Sep 02, 2014 Hatchtech Announces Successful Phase 3 Results
Dec 11, 2013 Hatchtech Receives SPA and Announces Patent Grants