We would like to welcome a new small business sponsor to ACT-AD, Anavex Life Sciences Corp. To help you learn more about what it does, we share this interview with its President and CEO Christopher U. Missling, MS, Ph.D., MBA. Please note that the views and opinions of Dr. Missling are purely his own.
Q: Tell us more about Anavex.
A: Anavex Life Sciences Corp. (OTCQX: AVXL) is a publicly traded biopharmaceutical company based in New York City. We, at Anavex, are driven to find a solution to the largest and fastest growing therapeutic area, Alzheimer’s disease. We are also engaged to continue developing novel drugs for the treatments of other central nervous system (CNS) diseases, pain, and various types of cancer. Our Company has made important advances in the past year from presenting successful Phase 1 data for the Company’s lead drug candidate, ANAVEX 2-73, to smartly structuring and enrolling a state-of-the-art adaptive Phase 2a clinical trial of ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), for the treatment of Alzheimer’s disease.
Q: What is your focus in regard to Alzheimer’s R & D?
A: Anavex believes Alzheimer’s disease could be potentially manifested through protein misfolding in the brain, which could turn into chronic cell distress. In this situation the brain is not able to fend off the protein misfolding that could accumulate over time. The very high correlation of Alzheimer’s with age speaks to the manifestation of some constant aggression and probably the domino effect of the protein misfolding. The chronic distress in the brain might have many sources. It could be caused by genetic factors, anxiety, lack of regular sleep, lack of physical exercise, and poor diet. For example, we know today that all the things that are bad for the heart are also bad for the brain, such as a bad diet filled with high fatty acids and too much sugar. Hence, some physicians speak of Alzheimer’s as “diabetes Type III.” The chronic cell stress eventually might cause the aggregation of Abeta or Tau, the characteristic of many Alzheimer’s patients. Interestingly, our drugs don’t target Abeta or Tau directly. However, they have been shown to reduce them. Hence, our drugs might be addressing the cause of the disease.
Our lead compound, ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors. Our research shows sigma-1 receptors to be the key cellular survival proteins in neurodegenerative diseases. Our drug therapeutic targets the sigma-1 receptor in order to activate a “Quality Control.”
It is also important to note we have successfully completed Phase 1 with a clean data profile. Safety data is a very important aspect of the drug because Alzheimer’s patients are mostly older and might have compromised heart function. ANAVEX 2-73 did not show any changes in ECG or lab parameters and had no serious side effects. Also, from a pharmacokinetic point of view, our drug can be administered once daily.
Now, we have ANAVEX 2-73 as well as ANAVEX PLUS in a Phase 2a trial. This trial aims to confirm safety as well as show the effect of the drug as soon as possible in order to have a building block for a later prevention study.
Q. Are there any particular projects you are most excited about?
A: The Phase 2a trial is a very exciting step. We dosed the first Alzheimer’s patient recently in January. The Company is looking forward to getting full trial data late this year, hopefully by third quarter of 2015. Also, we understand from third party publications in the
last year that other diseases, which are known to be neurodegenerative in nature, seem to be also benefiting from an increase of the expression of our target, the sigma-1 receptor, which our drug does. Hence, we hope we can also go forward with our drug in other central nervous system indications in order to provide relief to more patients afflicted with neurodegeneration.
Q: What inspired Anavex to join with ACT-AD as a small business sponsor?
A: I was fortunate to meet the Alliance for Aging Research and the ACT-AD team at the BIO Conference in San Diego. I was happy to be introduced to an organization that shared the same interest of finding a potential cure or treatment to slow, halt, or reverse Alzheimer’s disease. Our team at Anavex found it only natural to want to join ACT-AD in order to advance in efforts for our common goal. We understand that solving the current unmet need of a lack of a viable therapeutic does not take one person, one scientist, or one small company. It takes a team and collaboration in order to research and find something for the people affected by this disease. We find the Alliance to be one of the best leaders in the Alzheimer’s campaign, and we look forward to continuing to do what we can in order to support the ACT-AD Coalition.
Q: What is your take on the current state of Alzheimer’s research?
A: I understand that the research resources available for Alzheimer’s are still much lower than for cancer. Regarding the clinical development, the recent clinical trials targeting and reducing Abeta directly unfortunately did not show fully positive outcomes. What we believe we are doing differently is that we are trying to aim for the potential cause of the Abeta aggregation, not just to target Abeta. We believe our drug is targeting the disease in a more upstream manner and possibly addressing the cause of the disease.
It is also important to point out we are a small company, not a big pharmaceutical commercializing drugs. We realize wall these trial failures have led to some fear in treating this area. Although recent trial disappointments have occurred; research should not be restricted, rather further supported. We are happy there are organizations such as ACT-AD helping get this voice out there.
Q: What should we focus on in the future?
A: We should all be aware that there are preventative steps that patients and your readers, who are concerned about Alzheimer’s, could incorporate into their life today. Certain lifestyle factors such as diet, exercise, and sleep seem to play an important role in brain health. It has been recently confirmed in studies that incorporating a Mediterranean diet might delay Alzheimer’s symptoms. Basically, one should avoid diets filled with high fatty acids and avoid too much sugar. Physical exercise should also be part of the routine. Overall, it’s important to understand that although this disease cannot be prevented entirely, certain lifestyle factors could aid in reducing the disease’s effect. So, we all need to focus on trying to live a healthy, balanced lifestyle.
Also, please keep your eyes on our Phase 2a trial for the treatment of Alzheimer’s. We are expecting data from the ongoing study in the third quarter of 2015, and the Company’s strives for a positive outcome in order to provide relief to all those affected by this terrible disease.