• 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
Email:  halsop@hatchtech.com.au

Peter Devine, CEO Uniseed
T: +61 (0)409 631 581
Email:  p.devine@uniseed.com


About Hatchtech

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.

About Uniseed

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.