Lightlake Therapeutics Inc. (LLTP-OTC: BB)
February 11, 2011 Issue
The Most Powerful Name In Corporate News and Information
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
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.
Obesity and Eating Disorders
London, W1U 7BU United Kingdom
Phone: 44 20
CEOCFO: Dr. Crystal, what attracted you to Lightlake?
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?
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?
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?
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?
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
CEOCFO: Will you be looking to do partnerships?
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?
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?
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?
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?
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.
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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