LONDON--(BUSINESS WIRE)--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.
- Prospective Treatments
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.