[October 21, 2014] |
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Hatchtech Announces Successful Results from Phase 2 Ovicidal Study
MELBOURNE, Australia --(Business Wire)--
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 usin 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."
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.
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