Friday, May 4, 2012

Lightlake Therapeutics(OTCBB: LLTP) Positive Clinical Trial Results of Binge Eating Disorder Treatment

Lightlake Therapeutics(OTCBB: LLTP) Positive Clinical Trial Results of Binge Eating Disorder TreatmentAtlanta, GA 5/4/12 (StreetBeat) -- Lightlake Therapeutics Inc. (OTCBB: LLTP) (the "Company" or "Lightlake"), an early stage biopharmaceutical company developing addiction treatments, announced today very encouraging preliminary results in the Phase II clinical trial of the Company's opioid antagonist 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.

Lightlake's randomised, double-blind, placebo-controlled, six month Phase II clinical trial enrolling 127 subjects in Helsinki for the treatment of binge eating disorder (BED) with intranasal naloxone has been completed successfully. There were no serious adverse events and 81% of patients completed the entire 6 months with no statistically significant difference in dropout rates between the placebo and the treatment groups.

The primary endpoint was measured as the time (minutes) per week spent binge eating. The group receiving naloxone showed a highly significant (p<0.001) reduction in their time spent binge eating. The trial was designed to provide the best treatment to both groups except that only the naloxone group received the active medication. Consequently, the placebo group also reduced their time spent binge eating. The reduction for the naloxone group, however, was significantly (p=0.024) greater than that for the placebo group. The reduction in the final week was 56% greater with naloxone (158 min) than with placebo (101 min).

The reduction in bingeing showed the same pattern across time (called an "extinction curve") as has been previously reported for the treatment of alcohol dependence with similar opioid antagonists. The behavior shows little change during the first few weeks of treatment, but the effect becomes progressively greater month after month. "We are pleased that the data showed that there is an 'extinction curve' – where the benefits of the drug therapy improved over time," commented Dr. David Sinclair, Chief Scientific Officer, Lightlake Therapeutics. "We know from our earlier research that permitting people to engage in their problematic behaviour – here binge eating – while at the same time receiving drug therapy, results in the person losing interest in that behaviour, essentially 'extinguishing' binge eating."

The other primary endpoint was measuring the improvement on a standard questionnaire concerning how subjects felt about their binge eating in the previous month (Binge Eating Scale, BES). Both groups showed highly significant improvement during the trial, however there was no significant improvement of the naloxone group over placebo.

The naloxone treatment is not directly an obesity drug, but it does eventually remove the binge eating behavior that can produce obesity. Whilst weight loss was not a primary outcome measure, it was observed that during the first half of the trial (weeks 1 to 12), while binge eating was still frequent, as expected, the BMI (body mass index) continued to increase for both the placebo and naloxone groups, but during the second half of the trial (weeks 13 to 24), when binge eating was greatly reduced, the naloxone group (but not the placebo group) showed a statistically significant (p=0.039) reduction in BMI.

"We are very pleased with the preliminary results of this study, and we will continue to conduct further evaluation on the additional data captured in the study," said Dr Roger Crystal, M.D, CEO of Lightlake Therapeutics Inc. "Lightlake is committed to research that can help us advance our treatment of BED and other addictive behaviours – disorders that affect millions of individuals worldwide. The data from this study provides further evidence that naloxone may also be a promising treatment for Bulimia Nervosa, which is another related disease that is covered in our patent portfolio. We will work closely with regulatory authorities, to launch further studies to confirm naloxone as a suitable treatment for Binge Eating Disorder."

Dr. David Sinclair PhD, developer of the extinction method for treating addictions, stated, "The improvement shown by the binge eaters given naloxone in this trial is similar to what we have seen repeatedly in the treatment of alcoholism. The magnitude of the effect and also the rate at which it develops are just about the same as with alcoholism. This supports our contention that binge eating is an addiction and can be treated successfully with a method shown to work with other addictions. Moreover, it can be done with a single medicine having a long record of safe usage."

Please contact www.thestreetbeat.com for interest in our latest investor relations platform the “CEO Interview Series” with its host Steve Kanaval. The package includes a one-on-one interview with a seasoned industry professional; published segment to our web site with embedded audio/video file; and a compressed file that can be easily e-mailed out to your current and/or potential investors. Please e-mail bflautt@gmail.com or call (662) 392-0740 for pricing and scheduling.

StreetBeat Disclaimer

Distributed by Viestly

No comments:

Post a Comment