Lightlake Therapeutics Inc. (LLTP-OTC: BB)

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February 11, 2011 Issue

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Lightlake Therapeutics Inc. Is Bringing Hope In The Area Of Obesity With Their Opioid Antagonist Nasal Spray Which Could Offer A Solution To Obese Binge Eating Patients

Company Profile:

Lightlake Therapeutics Inc., is an early stage biopharma company that aims to develop novel treatments based on our expertise using opioid antagonists. Currently, the main focus, is developing a nasal spray to address binge eating obesity The company is based in London, United Kingdom.

Dr. Roger Crystal,
President and CEO
Lightlake Therapeutics Inc
.
Roger Crystal began his career as a surgeon in the UK, becoming a member of the Royal College of Surgeons of England and specializing in ENT surgery, at St Mary’s Hospital, part of Imperial College Healthcare, London. He holds degrees in Medicine and Physiology and was an Honorary Research Fellow at University College London. He is the author of a number of peer-reviewed scientific articles. Since then he has completed an MBA at London Business School, which included experience in investment banking at Goldman Sachs International. He then spent almost 2 years in healthcare strategy management consulting at A.T Kearney.


Interview conducted by: Lynn Fosse, Senior Editor
CEOCFOinterviews.com, Published – February 11, 2011


Healthcare

Obesity and Eating Disorders

(LLTP-OTC: BB)


Lightlake Therapeutics Inc.
54 Baker Street, 6th Floor

London, W1U 7BU United Kingdom

Phone: 44 20 7034 1943
 

CEOCFO: Dr. Crystal, what attracted you to Lightlake?

Dr. Crystal: My background is as a physician and I have seen so many patients that are overweight and obese. Further, I realized that there was no satisfactory treatment to deal with these patients, certainly from a medical perspective. So when I was invited to join Lightlake by company founder and chairman, Dr. Michael Sinclair, I felt very privileged to be part of the team. We are dealing with a society where addiction to food is a real problem on a global scale, and Lightlake’s pipeline offers a very compelling method to address this.
 

CEOCFO: What is the science behind it?

Dr. Crystal: The science is based on the pioneering research into the treatment of alcohol dependency by our Chief Scientific Officer Dr. David Sinclair. When opioid antagonists are used correctly, in the presence of alcohol, at 3 year follow up, 78% of patients no longer drink alcohol or drink it at safe levels. [NB: no relation to the chairman, Michael Sinclair] Dr. David Sinclair is applying this same science to address those patients who are obese because of binge eating. Approximately, one third of obese and overweight patients exhibit binge eating behaviour, and have several addictive characteristics. These patients have a lack of control eating certain foods, that are typically high in sugar, fat or salt, they are able to override the feeling of fullness and finally they are preoccupied with eating these foods constantly. Each time these patients eat foods with high levels of sugar, salt or fat, there is a release of endorphins, which activate opioid receptors, which results in the addictive behaviour. If you can block these opioid receptors, using an opioid antagonist, then you can block the effect these endorphins have each time these foods are eaten. We feel that is a very convincing way to address binge eating.
 

CEOCFO: How does this block the opioid receptors?

Dr. Crystal: Opioid antagonists block opioid receptors, so endorphins are unable to exert their effects, in the presence of eating foods that are high in sugar, fat and salt are ingested. We expect, as with using naltrexone for alcohol addiction, that patients will simply lose interest in eating certain foods and will not think about these foods anymore. As our medication is going to be a opioid antagonist nasal spray patients will simply take the spray just before they feel the need to binge eat, rather than relying on typical dieting methods, or the necessity to take medication lifelong. What we expect with time is that they will require less and less of this type of food until they get to the state where they are not even thinking about it.
 

CEOCFO: What about any potential side effects?

Dr. Crystal: We are using a safe, old and well established molecule and repositioning it to be used in this condition. Opioid antagonists have been around for decades and have been used both acutely in situations of drug overdose and chronically for alcohol addiction. What we are doing is using an opioid antagonist as a nasal spray for those patients who are overweight or obese as a result of binge eating.

 

CEOCFO: Where are you in the development process?

Dr. Crystal: We are looking to start a Phase II randomised double blinded placebo control trial in March this year, which will last six months and will take place in Helsinki. This is where Dr David Sinclair is based and there is a team of internationally renowned doctors and scientists who have conducted similar trial with great success. We have already found suitable patients for that trial, and have identified a suitable manufacturer for the nasal spray.
 

CEOCFO: What about affordability once it gets on the market?

Dr. Crystal: We are at an early stage to provide details, however there are no obvious reasons why this should be any more expensive than other anti-obesity medications.
 

CEOCFO: Will you be looking to do partnerships?

Dr. Crystal: Our strategy is to build a business that not just focuses on the use of opioid antagonists for binge eating obesity, but to leverage our expertise and look at other indications as well. We have just announced acquiring an additional patent, to use opioid antagonists for treating addictions to methadone, opioid painkillers such as Oxycontin, cocaine and NMDA drugs. However, in particular with this opportunity we would look to have partnerships to help fund our Phase III.
 

CEOCFO: Would you be addressing the US market first or will you be looking internationally?

Dr. Crystal: The US and UK markets area priority and, Imperial College London have agreed to host the Phase III trials. We have had significant interest for hosting additional Phase III sites in North American centers and therefore we expect Phase III will also be taking place in the United States.
 

CEOCFO: Has the medical community been paying attention, or is it a little early for them?

Dr. Crystal: Yes the medical community that we have engaged with so far is very supportive. Physicians are desperate to have a safe and effective pharmacological therapy to address obesity. They are highly supportive of Lightlake for two reasons. Firstly, it is because we are using a molecule known to be extremely safe. Secondly because of our selective approach: Rather than trying to address all patients who are obese, we only looking to address those patients when the underlying cause of their obesity is binge eating. In fact to participate in the Phase II trial, patients must meet the criteria for Binge Eating Disorder.
 

CEOCFO: Do you do much outreach to the investment community, and are investors paying attention?

Dr. Crystal: We are listed on the OTCBB and presented at the Rodman and Renshaw European Biotech Conference in the summer, we have also been getting some significant media attraction recently through being featured in the Sunday Times. Investors really buy into the concept of this being a huge opportunity with a market potentially worth billions. They highly value the potential safety of our approach over those companies whose drugs have recently been rejected by The FDA.

 

CEOCFO: You mentioned that you will be looking for a partnership to help take your product through Phase III clinical trials; what is the financial position of Lightlake Therapeutics today?

Dr. Crystal: We are raising some final funds to complete the Phase II study in Helsinki. Afterwards, we will be seeking to raise more capital to fund Phase III, either through partnerships or through the equity markets.
 

CEOCFO: In closing, why should potential investors consider Lightlake Therapeutics today?

Dr. Crystal: 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. Secondly, we are adopting a more selective approach, rather than trying to address all obese patients, we are recognizing that there is a specific group that will benefit from our treatment. We expect that the proportion of patients who will regain control of their eating and lose a significant amount of weight in our study population will be much higher than other anti-obesity trials. Finally, we don’t expect patients to be taking our medication in a chronic life long manner, which is one area of concern the FDA has had over recent drugs.

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As our medication is going to be a opioid antagonist nasal spray patients will simply take the spray just before they feel the need to binge eat, rather than relying on typical dieting methods, or the necessity to take medication lifelong. - Dr. Roger Crystal

 

 

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