• Ovicidal efficacy  confirmed in a Phase 2 clinical study
  • Primary  endpoint met  with  100% of eggs  treated 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 builds 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
Email:  halsop@hatchtech.com.au

Gabriella Hold, Buchan Consulting
T: + 61 3 8866 1203
Email:  ghold@buchanwe.com.au

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.