MELBOURNE, Australia -- (BUSINESS WIRE) -- Specialty pharmaceutical company Hatchtech Pty Ltd today announced positive results from 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 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, randomized, multi-center, 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 Phase 3 studies demonstrated that a single, ten minute application
of Xeglyze™ Lotion results in a statistically significant increase in
the proportion of subjects who are cleared of lice compared with the
vehicle lotion. They showed 81.5%1 of patients who received
only one application of Xeglyze™ Lotion and without nit-combing remained
lice free at all follow up visits through to the day 14 visit, which was
the primary efficacy endpoint as agreed with the FDA. The secondary
efficacy endpoint was the proportion of subjects who were lice free at
the Day 1 visit and the Day 7 visit. The studies showed 90% of subjects
were lice free after just one day following treatment with Xeglyze™
Lotion, and 88% were lice free after 7 days.
There were no serious adverse events related to treatment with Xeglyze™ Lotion, and no subject discontinued either study due to an adverse event. Reported adverse events were predominantly mild or moderate in nature and the product was well tolerated.
Based on research conducted at the University of Melbourne by Hatchtech’s founder Dr Vern Bowles, the active ingredient of Xeglyze™ Lotion, abametapir, was selected in 2005 as a lead compound, targeting key biological pathways of the lice life cycle, including the lice egg. Xeglyze™ Lotion is different to other head lice treatments by treating both eggs and the lice, meaning repeat applications and nit combing are not required. In addition, Xeglyze™ Lotion has a different mechanism of action with no known resistance. There is a need for novel treatments given that head lice have developed resistance to many currently available products.
“The successful eradication of a head lice infestation involves treating the lice as well as the eggs. Nit combing has traditionally been the only truly effective way of controlling the eggs and thus reinfestation. The results of these studies demonstrate that Xeglyze™ Lotion is effective at eliminating a head lice infestation in 81.5% of subjects, but most importantly with only one application and without nit combing” commented, Dr Lydie Hazan, CEO of Axis Clinical Trials in Los Angeles, and a Principal Investigator on one of the Phase 3 studies. Dr Hazan is a respected head lice expert and has been involved in the development of a number of head lice products.
Hatchtech CEO, Hugh Alsop said: “This is a very exciting result, providing clear evidence in support of the safety and efficacy of Xeglyze™ Lotion, as well as the superior commercial potential of the product. Success with these studies now places Hatchtech in a strong position to seek marketing approval in the US as well as accelerate our plans for the commercialisation of Xeglyze Lotion. The company remains on track to file a New Drug Application with the US Food and Drug Administration in the first half of 2015.”
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.
1 81.1% for study 001 and 81.8% for study 002.