21 October 2014
Ovicidal efficacy confirmed in a Phase 2 clinical study
Primary endpoint met with 100% of eggstreated with Xeglyze™ Lotion remaining unhatched following a single 10 minute application
Results confirm previous in-vitro studies, where no eggs hatched following treatment with Xeglyze™ Lotion
Clinical development of Xeglyze™ Lotion now complete with exceptional efficacy data produced against both lice and eggs
Specialty pharmaceutical company Hatchtech Pty Ltd today announced positive results from a Phase 2 clinical study evaluating the ovicidal efficacy (ability to kill lice eggs) of a single, 10 minute application of Xeglyze™ Lotion developed as a treatment for head lice infestation. The study met its primary endpoint with Xeglyze™ Lotion demonstrating 100% ovicidal efficacy when compared to a vehicle lotion.
The study was conducted in Melbourne, Australia, and enrolled a total of 50 subjects at a single clinical study site. The study was a double-blind, randomized, vehicle-controlled, parallel-group study in subjects with an active head lice infestation aged three years and above. The study was designed to assess the ovicidal efficacy of a single application of Xeglyze™ Lotion 0.74% compared to a vehicle control, when applied to the scalp and hair for 10 minutes at the study site. A minimum of five eggs per subject were collected pre-treatment and five eggs immediately post-treatment. All eggs were then incubated for 14 days. The study endpoint measured the proportion of eggs that hatched pre-treatment relative to the proportion of hatched eggs post-treatment for Xeglyze™ Lotion and vehicle-treated eggs. Xeglyze™ Lotion demonstrated 100% ovicidal efficacy, with the hatch rate reduced from 93.3% pre-treatment to 0% post-treatment when compared to a vehicle lotion, which reduced the hatch rate from 79.5% to 36.0% (Xeglyze™ versus Vehicle p-value < 0.0001).
The outcome of this study confirms results from previous in-vitro studies using eggs sampled from a laboratory maintained head lice colony. In these in-vitro studies, eggs sampled from the colony were treated with Xeglyze™ Lotion, a vehicle lotion, a water control and Nix, a commercially available over-the-counter product containing 1% permethrin as the active ingredient. The eggs were then incubated for 14 days and observed for hatchability. None (0%) of the eggs exposed to Xeglyze™ Lotion hatched following incubation, compared to 56% of eggs exposed to the vehicle, 59% of the eggs exposed to the Nix product, and 87% exposed to the water control.
The results from both the clinical and in-vitro studies confirm the ability of Xeglyze™ Lotion to kill head lice eggs in a single 10-minute application and build on the recently released Phase 3 data that showed 81.5% of subjects remained lice free 14 days following a single 10 minute application of Xeglyze™ Lotion with no nit combing. Currently approved products on the market have little or no efficacy against eggs, meaning that if the eggs are not physically removed from the hair, an infestation will quickly return hence the need for multiple treatments and nit combing to kill the newly emerged lice.
Hatchtech CEO, Hugh Alsop said: “The results from this Phase 2 study, combined with the results using eggs collected from the laboratory maintained colony, clearly confirm the potent ovicidal efficacy of Xeglyze™ Lotion. 100% of eggs that come into contact with Xeglyze™ are killed. Hatchtech has now completed clinical development of Xeglyze™ lotion, producing exceptional efficacy data against both lice and their eggs that validates the unique benefit of Xeglyze™ Lotion for the treatment of a head lice infestation.”
For more information, please contact:
Hugh Alsop, CEO Hatchtech Pty Ltd
T: +61 (0) 439 080 353
Gabriella Hold, Buchan Consulting
T: + 61 3 8866 1203
Hatchtech Pty Ltd is an Australian specialty pharmaceutical product company developing technology for the control of invertebrate pests. The Company’s lead product is Xeglyze™ Lotion, a class-leading head lice control agent that aims to overcome the frustrating, costly and inconvenient cycles of re-treatment experienced currently by children and their parents. Hatchtech is a privately owned company whose investors include Uniseed, GBS Venture Partners, Queensland Biotechnology Fund, University of Melbourne Endowment Trust, Australian Super, Blue Sky Alternative Investments and the OneVentures Innovation Fund. The OneVentures Innovation Fund and GBS are supported by the Australian Government through the IIF program.
About Xeglyze™ Lotion
Hatchtech is developing Xeglyze™ Lotion, a single dose, single treatment, prescription product which addresses a significant unmet need for more effective head lice treatments. It is unique in that the product has been shown through clinical and in-vitro studies to kill both live lice and their eggs, in a single ten minute treatment – welcome news for any parent who has had to spend hours ‘nit combing’ their child’s hair following multiple lice treatments, as is often required with the products available on the market today.
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