Lightlake announces final data from naloxone nasal spray Phase II study on Binge Eating Disorder

Lightlake Therapeutics Inc. (OTCBB: LLTP) (the "Company" or "Lightlake"), an early stage biopharmaceutical company developing modern addiction treatments based on its expertise using opioid antagonists, announced today compelling final data from a Phase II study of the Company's proprietary opioid antagonist naloxone nasal spray treatment for patients with Binge Eating Disorder (BED). BED is a psychiatric condition that is manifested by recurrent episodes of eating unusually large amounts of food in a short period of time associated with a sense of lack of control over food intake.

BED is a major cause of obesity for those patients with addictive behavior towards food. It is the most chronic and common of all eating disorders with a significant cost to society, with 12 to 18 million people in the United States likely meeting the criteria for BED and a further 20 million people exhibiting bingeing behavior. It is significantly undertreated with no approved pharmacological therapies.

Patients receiving the naloxone nasal spray achieved the study's primary endpoint by exhibiting a statistically significant reduction in time spent per week binge eating compared to those patients who received a placebo nasal spray, reducing their bingeing by 125 minutes per week compared to 84 minutes per week for placebo-treated subjects (p=0.024).

The effect of the naloxone nasal spray was especially pronounced when comparing the baseline bingeing with the level of bingeing during the last week of treatment, with the patients receiving naloxone reducing their bingeing by 158 minutes per week compared to 101 minutes per week for placebo-treated subjects (p=0.018) during this period. Overall, 81% of patients completed the entire six-month study with no statistically significant difference in dropout rates between the placebo and the treatment groups and without any Serious Adverse Events (SAE) reported during the trial. In particular, none of the cardiovascular measures fell outside the ideal range, with no statistically significant difference between naloxone and placebo.

For those patients with a BMI>35 (regarded to be severely obese) the results were particularly impressive, with these patients reducing their bingeing by 210.8 minutes per week compared to 83.8 minutes per week for the placebo-treated subjects at the last week of the trial, (p=0.004). This 75.2% reduction in bingeing was achieved without patients receiving any dietary advice or psychotherapy. In fact, patients were instructed to continue eating as they would normally. This contrasts with other treatments that aim to reduce overeating - these require the patient adopt a modified diet.

Dr. Arya Sharma, Chair in Obesity Research and Management at the University of Alberta and internationally acclaimed obesity thought leader, notes, "By any measure, these are impressive results. Binge eating is a very common problem in my practice, particularly in my patients with severe obesity. These patients generally require extensive psychological interventions to control their eating behavior - a treatment that is not readily available to most patients with this disorder. The notion that bingeing can be significantly reduced with the simple application of a nasal spray would represent a major advance in the treatment of this common cause of obesity."

"These final results of the Phase II trial further confirm that our naloxone nasal spray is a very promising therapy for Binge Eating Disorder," said Dr. Roger Crystal, Chief Executive Officer of Lightlake. "We believe that the patients taking our naloxone nasal spray would have benefitted even more from this treatment if they were to continue taking it for longer. We also find it exciting that naloxone seems to work best on patients who are severely obese."

It also was observed that for those patients taking naloxone, the BMI decreased significantly from week 12 to week 24 (p=0.015) and there was a statistically significant reduction in the percentage of body fat (p=0.004) while the placebo did not have a substantial effect in this regard.

Dr. David Sinclair, Chief Scientific Officer of Lightlake, commented, "Naloxone is not an appetite suppressant, nor does it prevent the body from absorbing fat, but rather deals with the physiological and psychological underpinnings that cause cravings for foods high in fat, salt or sugar. As a nasal spray, naloxone acts within minutes selectively targeting the extinction of the harmful eating behavior. Naloxone exerts its effects over two hours, which is the typical duration of a binge, and is unlikely to extinguish other healthy behaviors such as the desire to exercise. With the results of this trial, we have additional evidence that strongly indicates continued use of the treatment would eventually extinguish the cravings for these types of foods altogether. This treatment is geared towards eliminating a harmful eating behavior that can lead to serious health problems and enabling people with BED to re-regain control over their eating habits."

By the end of the study, the naloxone group also showed significant decreases in their reported desire to binge (p<0.001), in their time spent thinking about binge eating (p<0.001), and in their reported level of depression (p=0.043), though these effects were not significantly better than in the placebo group.