- 81.5% of subjects treated with Xeglyze™ Lotion were free of lice following a single application and without nit combing
- Xeglyze™ Lotion demonstrated to be safe and well tolerated with no treatment related serious adverse events
- New Drug Application with FDA expected in the first half of 2015
- Xeglyze™ Lotion registered as a new trademark
Uniseed investee Hatchtech Pty Ltd today announced positive results from its two pivotal Phase 3 clinical studies that evaluated the use of 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).
Based on research conducted by University of Melbourne researcher Dr Vern Bowles, Uniseed was the sole investor when Hatchtech was formed in 2001 with the assistance of Melbourne Enterprise International (now UoM Commercial). Uniseed has continued to support the company through 6 major investment rounds, securing co-investment from GBS Venture Partners, Queensland Biotechnology Fund, OneVentures Innovation Fund and most recently Blue Sky Alternative Investments.
Dr Peter Devine, CEO of Uniseed commented: “Development of a head lice treatment from a concept to a successful Phase 3 clinical trial is an endorsement of the vision of the three partner universities in the fund (Universities of Melbourne, Queensland and NSW). Uniseed was established to facilitate commercialisation of university intellectual property, and this outcome highlights the quality of the science performed by Dr Vern Bowles at the University of Melbourne.”
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.
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.”
(1) 81.1% for study 001 and 81.8% for study 002.
For more information, please contact:
Hugh Alsop, CEO Hatchtech
T: +61 (0) 439 080 353
Peter Devine, CEO Uniseed
T: +61 (0)409 631 581
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.
Uniseed is a commercialisation fund operating at the Universities of Melbourne, Queensland and New South Wales, with investment capital provided by the three universities and AustralianSuper – a leading industry superannuation fund. Uniseed’s mandate is to facilitate the commercialisation of university-generated intellectual property by targeted investment in highly promising technologies.
Through Uniseed’s investment, a number of technologies arising from its partner universities are creating a major impact on society, ultimately enhancing the reputation of the universities from where these discoveries originated. Technologies funded by Uniseed address a number of global challenges in areas such as healthcare, disease prevention, functional foods, clean energy and education.
The impact of Uniseed funding reaches far beyond just the investee company. Through Uniseed investment, new technologies are nurtured, taking Australian university innovation to the world, and positioning Australia for the future.
Uniseed works in very close partnership with the universities’ commercialisation companies, UoM Commercial Ltd, UniQuest and NewSouth Innovations, providing a valuable adjunct to the capabilities these companies provide. They in turn provide a best-practice commercialisation service tailored to their respective universities, and are able to leverage to great effect the scale of operation and expertise of the Uniseed network.