I distinctly remember the first day I mourned the loss of my grandfather. The day he looked at me and couldn’t remember my name. The role reversal started the day we got the diagnosis of Alzheimer’s disease (AD), marking the beginning for years of memory loss, social withdrawal and isolation, and eventually, the inability to carry out the simplest task. When my grandfather succumbed to the disease, I mourned his loss once again. Though AD is more than losing memories, it doesn’t mean losing love.
This was the catalyst that inspired me to co-found INmune Bio and begin our search for a drug that major pharmaceutical players including Eli Lilly, Pfizer, Merck and Roche could not succeed, despite tens of billions of dollars and decades spent developing and testing drugs.
The approval of Biogen’s AD drug, Aduhelm, has been a beacon of hope to the patients and families of the six million Americans living with the disease, 14 million by 2050. However, this has been tempered by the recent announcement that it will only be covered by Medicare exclusively for patients enrolled in approved clinical trials.
Scientists don’t yet fully understand what causes AD in most people. It is most likely multifactorial including a combination of age-related changes in the brain, along with genetic, environmental and lifestyle factors. Conventional thinking is that AD is a progressive brain disease in which abnormal protein deposits build up in the brain (amyloid plaques) and tangles of neurons (neurofibrillary tangles) that result in loss of neurons and their connections. It involves parts of the brain that control thought, memory, and language. Traditional treatment targets the protein beta-amyloid and helps reduce the amyloid plaques. Anti-amyloid therapies, such as Aduhelm, which has been shown to decrease cognitive decline by up to 30%, is far from a cure, but is a first step in addressing AD being one of the first biologic drugs on the market to make a measurable dent on this fatal disease. However, the estimated $28,000 for this drug, potentially costing Medicare billions of dollars per year, has been a point of contention. I have heard the argument posed in healthcare: What advantage is gained from spending a fortune on AD treatment just to “delay” the inevitable? I would propose a different question. What would you pay to save your brain?
One in three seniors dies with Alzheimer’s or another dementia with direct costs including skilled nursing care, home healthcare and long-term care costing $355 billion in 2021. By 2050, these costs could rise to more than $1.1 trillion. Medicare/Medicaid covers the largest proportion of these costs, about $206 billion, while out-of-pocket costs are estimated to be around $66 billion. However, AD is a family disease. Indirect costs, including loss of a wage earner in a family and the financial and mental health impact on the caretaker, such as depression and anxiety, has often not been a part of the discussion. In fact, out-of-pocket costs alone can run near $85,000 per year per patient. Over 11 million Americans provide unpaid care for people with AD or other dementia, with caregivers accommodating for an estimated 15.3 billion hours valued at nearly $257 billion. This does not include the intangibles, such as quality of life and emotional impact of the patient and family. New therapies would certainly offset these costs, posing the question on around what price does one place on quality of life for the patient and family? As therapies improve, it would certainly not be unreasonable to predict in the foreseeable future, treating patients with AD would be cheaper than allowing the disease to take its course.
Should we be looking at AD treatment in the same way we look at cancer treatment? Although Aduhelm does not stop the progression of AD, it has been shown to slow cognitive decline. In the same vein, there are no cures for stage IV pancreatic cancer. However, costly chemotherapeutics and immunotherapies and can extend life by two years. This poses a question on if oncologists, cancer patients and their families feel the cost of the drug to “delay the inevitable” is worth it, which one would suspect that the answer would be a resounding “yes”.
Just as the first immunotherapies developed in the 1980’s paved the way for more effective treatments and cures for cancer, INmune Bio has created an “immunotherapy” for neurodegenerative disease. Xpro1595 (“Xpro™”) is a promising experimental biologic therapy shown to reduce neuroinflammation with the goal of arresting cognitive decline. The hypothesis behind Xpro™ is that dementia is caused by neuroinflammation that causes the immune cells in the brain to be dysfunctional, no longer protecting the neurons and synapses of the brain. By stopping chronic inflammation, it has been shown to allow the immune cells of the brain to protect and repair the neurons and synapses, which are the memory cells and wires that connect the different parts of the brain. It also facilitates the clearance of toxic cellular debris and normalizes the immune cell profile. This potentially might stop the progression of AD rather than slowing the decline as Aduhelm does.
In the future, I have hope that my children will not experience the two deaths of AD, death of body and soul. However, the current landscape of treatment cost poses the question on if it’s fair to only have current therapy available to those who can pay out of pocket given that millions of patients and loved ones will not have access to “delay the inevitable” until a cheaper, more perfect drug is produced? I only have to look across the street at the widow who had two extra years with his wife because they had access to the best available immunotherapy/chemotherapeutics. My answer is a resounding NO!
About David Moss
David Moss has been CFO and Co-Founder of INmune Bio since the formation of the Company in September 2015. Mr. Moss is a venture capitalist having founded, funded and taken public various companies 1995. He holds an MBA from Rice University and a BA in Economics from the University of California, San Diego.