Lightlake Therapeutics is a biopharmaceutical company that is leveraging its expertise in the field of opioid antagonists to build a solid platform of pharmacological solutions to treat common addictive disorders.

• Prior research by Dr. David Sinclair, Lightlake’s Chief Science Officer, has already resulted in a highly successful treatment for chronic alcohol dependency using the opioid antagonist, naltrexone.
• A Phase II clinical trial will commence soon in Helsinki to evaluate an opioid antagonist nasal spray for patients who are obese as a result of binge eating.

• Lightlake Therapeutics is an early stage biopharmaceutical company aiming to build a solid platform of pharmacological treatments based on our expertise using opioid antagonists.
• We aim to develop innovative biopharmaceutical solutions to treat common addictive disorders.
• Our current focus is to develop a safe, effective and simple treatment for patients who are obese or overweight as a result of binge eating. We expect to commence a Phase II clinical trial to investigate an opioid antagonist nasal spray in the early part of 2011.

In addition we have recently acquired patents that will allow us to widen our therapeutic pipeline to address patients with addictions to opioid painkillers, methadone, cocaine and amphetamine. We anticipate launching a development program for this purpose in the very near future.

Lightlakes Therapeutics will investigate the use of the opioid antagonist naloxone in a nasal spray as a treatment for patients who are obese or overweight as a result of binge eating.

This pivotal Phase II randomised double blind placebo controlled trial will take place in Helsinki, Finland early 2011 for a select sample of obese patients exhibiting Binge Eating Disorder.

This approach is based on the proven use of opioid antagonists to combat alcohol dependency.

We are also investigating a genetic marker for this order that may allow us to further refine treatment for the affected population.

We feel our treatment will succeed for binge eating and obesity because:

• The nasal spray  is unlikely to be used in a truly chronic manner. Patients will only take the nasal spray when they have the urge to binge-eat, and  will require less drug over time, as they regain control of their eating habits.
• The treatment has the ability to introduce a sustained healthy lifestyle, through learning new behaviors that become reinforced as part of the therapy. Based on research with alcohol dependency, we expect that patients will no longer exhibit cravings or even think about eating certain foods and will regain control of eating.
• Opioid antagonists are very safe  compounds. They been used for over 30 years, and have proven efficacy for weight loss and binge eating with no known side effects.
• Naloxone is the best opioid antagonist to address Binbge Eating Disorder, as It has a shorter half-life than naltrexone (present in ContraveTM  OREX) and is therefore particularly well suited to binge eating, and has been used chronically in Suboxone^TM.
• We will be using a selective approach. The naloxone  nasal spray will only be tested on a binge-eating obese and overweight population for  the Phase II trial. Therefore, a higher proportion of patients are expected to benefit from our treatment.

Obesity Starts with an Addiction to Certain Foods

Compared to decades ago, food now has significantly higher amounts of sugar, fat, and salt. These foods release endorphins that act on the opioid receptors in the brain, activating the opioidergic system. This results in patients having an addictive behavior to certain foods.

Over time, continued exposure to these foods can results in binge eating, whereby patients are:

1. Unable to control their eating of foods typically high in sugar, fat, or salt
2. Able to over-ride the feeling of fullness, through continued eating of these foods during a typical bingeing session
3. Constantly preoccupied with eating these foods.

Subsequently, many individuals will develop Binge Eating Disorder. Our treatment ends binge eating, so patients will regain control of their eating habits and lose weight.

Blocking the effect of endorphins on the opioidergic system by using opioid antagonists is a safe and effective way to stop patients from binge eating, and facilitates significant weight loss through patients regaining control of normal eating habits.

“Obesity is a huge global epidemic regarded to be a more significant global health concern than smoking. There is currently limited effective medical treatment. We are using a molecule that is known to be safe.”

Dr. Roger Crystal, CEO