Lightlake Therapeutics Inc. (OTCBB: LLTP - News) (the “Company”
or “Lightlake”), an early stage biopharmaceutical company using its
expertise of opioid antagonists to develop modern treatments for
addictions and related disorders, announced today its financial
results for the year ended June 30, 2011.
Selected Highlights
During fiscal 2011 and up to the date of this press release,
Lightlake achieved the following milestones:
Commences Binge Eating Disorder Treatment Phase II Trials
- In the third quarter of 2011, Lightlake
commenced Phase II trials in Helsinki, Finland, to investigate the
use of the opioid antagonist naloxone intra-nasally as a treatment
for Binge Eating Disorder, which is the most common eating disorder
in the US today
These trials are being held at and in conjunction with the
National Institute of Health and Welfare in Helsinki, Finland. 138
patients meeting the criteria for Binge Eating Disorder were
randomly selected from over 900 applicants wanting to participate
in these trials, which involve randomized, double blind placebo
controlled tests. While each patient is randomized to take either
intranasal naloxone or a placebo nasal spray, all of the patients
are partaking in an exercise program—a behavior that Lightlake
believes can be reinforced through this approach. Some of the
participating patients carry the A118G, which is a genetic variant
for the Mu Opioid receptor, and the Company will determine whether
their response to treatment differs.
Professor Hannu Eero Rafael Alho, Professor of Addiction
Medicine at the University of Helsinki, is serving as the trial
coordinator and Crown CRO, a Finnish research organization involved
in approximately 300 clinical trials over the years in addition to
90 clinical trials in progress, is providing the external
validation. Lightlake has identified a suitable nasal spray
manufacturer and has agreements with both Celesio AG and Lloyds
Pharmacy. At the start of these trials, Lightlake projected that
testing will take six months to complete.
Preparing Bulimia Nervosa Treatment Phase II Trials
- In the third quarter of 2011, Lightlake
made arrangements with Kings College London, UK, to conduct Phase
II trials at and in conjunction with the institution to investigate
use of an opioid antagonist-based nasal spray treatment for Bulimia
Nervosa, which a condition affecting approximately 5 million people
in the US today with only about 50% of these patients finding
successful treatment options
In potentially working with Kings College, which has an
internationally renowned eating disorder unit, Lightlake seeks to
considerably strengthen the Company’s already distinguished
research and development team. Professor Janet Treasure, head of
the Eating Disorders Unit at the South London and Maudsley NHS
Trust and author of several well-regarded books on eating
disorders, and Professor Ulrike Schmidt, a consultant psychiatrist
for the Eating Disorders Service and a fellow of the Academy for
Eating Disorders, are the prospective guides for these trials,
which Lightlake anticipates commencing in 2012.
Pipeline Review
- Binge Eating Disorder Treatment
The science Lightlake is using to develop a treatment for Binge
Eating Disorder is derived from the “Sinclair Method,” which was
founded by the Company’s Chief Science Officer, Dr. David Sinclair.
In 1990, Dr. Sinclair discovered that the opioid antagonist
naltrexone, when used correctly in the presence of drinking
alcohol, decreased the craving for alcohol in alcoholics.
Naltrexone has demonstrated a 78% success rate in helping patients
abstain from alcohol or consume it at safe levels at long term
follow-up. In 1989, Dr. Sinclair patented his "Method for Treating
Alcohol Drinking Responses,” also known as the “Sinclair Method,”
and in 1994, the FDA approved the use of naltrexone as a treatment
for alcohol dependence. Since then, the “Sinclair Method” has been
used by medical practices around the globe as an effective
treatment for alcoholism.
Similar to how an alcoholic tends to perceive and consume
alcohol, patients suffering from Binge Eating Disorder typically
exhibit a lack of control eating foods typically high in sugar, fat
or salt, are preoccupied with eating these types of foods, and are
able to override the feeling of fullness. When these patients eat
foods with high levels of sugar, salt or fat, the opioidergic
system is activated, which causes the firing of the neurons that
release endorphins. The endorphins then bind to opioid receptors on
other neurons and activate these opioid receptors, which reinforces
the addictive behavior. By blocking these opioid receptors with an
opioid antagonist, the effect these endorphins have each time these
foods are eaten is counteracted.
Lightlake considers naloxone the optimal opioid antagonist to
address Binge Eating Disorder as naloxone remains in the brain for
two hours, which is the duration of a typical binge. Moreover, the
Company expects the nasal spray is unlikely to be used in a truly
chronic manner—patients would only administer the treatment when
they have the urge to binge eat, and would require less of the
spray over time as they regain control of their eating habits.
- Bulimia Nervosa Treatment
Lightlake is aiming to commence Phase II trials in 2012 to
investigate an opioid antagonist-based treatment for Bulimia
Nervosa, as the Company is confident that it can apply the same
science it is using to develop a treatment for Binge Eating
Disorder to develop a solution for Bulimia Nervosa.
Lightlake has patents that will enable the Company to widen its
product pipeline to address patients with addictions to opioid
painkillers, methadone, cocaine and amphetamine. Additionally,
Lightlake is also looking to develop a treatment for opioid
overdose based on the Company’s expertise using opioid antagonists.
The Company anticipates announcing a partnership with a leading
addiction institution in the future to commence an overdose program
that will further leverage Lightlake’s capabilities using opioid
antagonists by applying a novel technique to enhance the current
treatment for overdose.
About Lightlake Therapeutics, Inc.
Lightlake Therapeutics Inc. is a developing biopharmaceutical
company aiming to build a platform of biopharmaceutical solutions
to common addictions and related disorders. Currently, the Company
is focused on providing a safe, effective and simple treatment for
patients who are obese or overweight as a result of Binge Eating
Disorder in addition to those patients suffering from Bulimia
Nervosa. Lightlake recently acquired patents that will allow it to
widen its product pipeline to address patients with addictions to
opioid painkillers, methadone, cocaine and amphetamine. The
Company anticipates launching a development program for each of
these purposes in the future.
Safe Harbor
This press release contains forward-looking statements. These
statements relate to future events or our future financial
performance and involve known and unknown risks, uncertainties and
other factors that may cause our or our industry's actual results,
levels of activity, performance or achievements to be materially
different from any future results, levels of activity, performance
or achievements expressed, implied or inferred by these
forward-looking statements. In some cases, you can identify
forward-looking statements by terminology such as "may," "will,"
"should," "could," "would," "expects," "plans," "intends,"
"anticipates," "believes," estimates," "predicts," "projects,"
"potential" or "continue" or the negative of such terms and other
comparable terminology. These statements are only predictions based
on our current expectations and projections about future events.
You should not place undue reliance on these statements. Actual
events or results may differ materially. In evaluating these
statements, you should specifically consider various factors. These
and other factors may cause our actual results to differ materially
from any forward- looking statement. We undertake no
obligation to update any of the forward-looking statements after
the date of this presentation to conform those statements to
reflect the occurrence of unanticipated events, except as required
by applicable law.
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