I would like to take this opportunity to provide you with a comprehensive look at our present and upcoming endeavors.
As you may have seen in several of our press releases and elsewhere on our website, we are currently conducting Phase II trials in Helsinki, Finland, to investigate our opioid antagonist-based nasal spray treatment for Binge Eating Disorder (BED). We are also preparing for the Phase II trials of our opioid antagonist-based nasal spray treatment for Bulimia Nervosa—these trials will be held at King’s College London hopefully next year.
For the Phase II trials of our BED treatment, we have over 100 patients—all of whom meet the criteria for Binge Eating Disorder—participating in the trials. Each patient is randomized to take either intranasal naloxone (the opioid antagonist in our nasal spray) or a placebo nasal spray, and all of the patients are partaking in an exercise program, a behavior that can be reinforced through this approach. We expect that these trials will demonstrate that our nasal spray will be a compelling solution to BED.
Crown CRO, a distinguished Finnish Contract Research Organization involved in approximately 300 clinical studies over the years in addition to 90 clinical trials currently in progress, is providing the external validation for these Phase II trials. Additionally, Hannu Alho, professor of addiction medicine at the University of Helsinki, is serving as the lead investigator for these trials.
In regard to the forthcoming Phase II trials of our Bulimia Nervosa treatment, we are confident that we can apply the same science we are using to develop a treatment for BED to develop a solution for this condition. Moreover, we are very pleased to be working with King’s College London, which has an internationally renowned eating disorder unit, and to have a leading team to coordinate the trials. Once this is underway, we will then look to develop other areas in our pipeline centred around the patents for cocaine, opioid and amphetamine addictions.
I hope this overview has helped you gain a better understanding of our current and future undertakings. We will continue to provide you with updates as our operations progress. On the behalf of all us at Lightlake, I thank you for your interest in our Company.
-- Dr. Roger Crystal, CEO