Peggy Wallace, Managing Partner, Golden Seeds and member of the Board of Directors of Cognition TherapeuticsJuly 8, 2020
We’re thrilled to announce that Golden Seeds company Cognition Therapeutics recently received a $75.8 million grant to fund a Phase 2 clinical trial of the therapeutic CT1812 in individuals with early Alzheimer’s disease.
We’re continually inspired by the incredible work being done at Cognition Therapeutics, a clinical-stage drug development company focused on the protection and restoration of synaptic function in Alzheimer’s disease and other neurodegenerative disorders. This grant is a testament to the groundbreaking research being done at Cognition Therapeutics.
The National Institute on Aging (NIA) of the National Institutes of Health (NIH) awarded the grant funding for the trial, which will be conducted over five years at 35 leading academic sites with expertise in Alzheimer’s clinical trials. The study will focus on 540 individuals with mild cognitive impairment from Alzheimer’s disease or early Alzheimer’s. Trial participants will be randomized – receiving either CT1812 or placebo for 18 months, and biomarkers will be used to determine changes in disease progression and neurodegeneration.
We recently caught up with Cognition Therapeutics Co-Founder and Chief Science Officer Dr. Susan Catalano, and recently appointed CEO Lisa Ricciardi to discuss the grant, how to enroll in clinical trials, and other exciting updates at this Golden Seeds-funded company.
PW: Congratulations on this landmark NIH grant. Can you explain what the $75.8M, five-year grant funds, specifically?
LR: Susan started working on this well over two years ago and it’s really the capstone of our early work. It’s an opportunity to expand on all of our early studies and work, and a major milestone for our company as this will tell us if our drug is working.
SC: This is a special grant in that it’s a peer-reviewed clinical trial. It’s supported independently by the NIH and NIA. We went through an incredibly competitive process scored by a steering committee composed of leading world-wide scientific experts in clinical trials and neurodegenerative diseases. The magnitude of this grant dwarfs any other NIA-funded grant as top grants have previously been in the $10-14 million range. And that’s really a recognition of what it takes to properly study this disease.
PW: So many people today are impacted by Alzheimer’s disease, but can you give us a sense of how big a problem it is globally, both in terms of the number of cases and what it costs our healthcare system?
SC: We are in excess of 16 million cases worldwide and almost 6 million in the U.S. In terms of cost, it’s an astonishing $244 billion a year in the U.S. in direct expenses and the indirect costs are even worse. And those direct and indirect costs together are the No. 1 cause of bankruptcy for families with a loved one with Alzheimer’s.
LR: On top of the nearly 6 million cases in the U.S., we’re averaging another half-million cases a year. Again, those indirect costs are a big part of the problem. In general, from the time of diagnosis, Alzheimer’s patients are living five to seven years, and in that window they need 24-hour-a-day care. Generally, people with Alzheimer’s are living longer, which increases the need and costs associated with around-the-clock caretaking. Alzheimer’s alone – just this one disease – could bankrupt Medicare.
PW: You have a novel approach in how you’re targeting Alzheimer’s disease. How is your approach different than what we’ve seen before, particularly theories and associated trials that target the amyloid protein?
LR: It’s a mission to work in this area of disease research because so many companies before us have failed. But we’re targeting the disease in a fundamentally different way. What if it’s the first part of the puzzle toward a cure? It’s a satisfaction of a lifetime to work in this field and to work with Susan and the team at Cognition Therapeutics.
SC: Our drug candidate CT1812 stops the toxic amyloid beta protein that sets Alzheimer’s disease in motion and keeps it in motion by targeting the sigma-2 receptor, and this is a completely new approach and a new way of looking at the disease. There are no other drugs that work the same way.
It’s so unique that the NIH and the NIA refer to us as a “next generation anti-amyloid” therapeutic. For many years, the focus had been on the fibril form of the amyloid beta protein (a polymer that’s arranged in a very long chain), but actually the most toxic form of the protein is shaped like a globule or sphere, called an oligomer. The reason it’s so toxic is that it binds to brain cells and induces changes that disrupt normal memory formation. As those changes persist, the brain cells die. Stopping Alzheimer’s disease progression is going to depend on stopping this fundamental toxin. CT1812 is the only drug that does this effectively.
PW: How do prospective participants learn about and enroll in clinical trials?
SC: The best place to look for information regarding clinical trials is to check (and check frequently) clinicaltrials.gov. That has the main contact number for each clinical trial site, and the inclusion/exclusion criteria. We’ll, of course, advertise our trials, as will our 35 academic sites. People need to consult their physician before participating in any clinical trial.
PW: Are you currently working on any other treatments for neurodegenerative diseases beyond Alzheimer’s?
SC: We have begun exploring age-related macular degeneration and Parkinson’s disease, two closely related diseases where there is a sound scientific rationale for sigma-2 receptor antagonists to be therapeutic.
PW: You recently announced a new CEO. Can you comment on how you expect this leadership change to shape the company’s future?
SC: We are incredibly fortunate to have Lisa as our CEO. Her background experience is perfectly suited to where we are as a company today.
LR: I served as a Cognition Therapeutics board member for a year and was recruited by the former CEO. When the CEO opportunity came up, I was excited, particularly because of the environment we were in. My background is split between transactional – both buying and selling companies – and spending time with teams launching drugs, and that felt like the perfect combination to broaden our focus.
My experience includes business development and banking, negotiating M&A and collaborations. At Pfizer, I worked closely with commercial teams to launch Norvasc, Zithromax and Trovan. In retrospect, it feels like an excellent combination of experience to lead Cognition at this time. I give a great deal of credit to Susan for the team that she built and the infrastructure she put into place.
PW: Other than the exciting grant and new CEO news, what’s new with Cognition Therapeutics since the last time we featured you in spring 2018?
SC: We learned a great deal from the changes that occurred in the first set of 24 patients we treated for six months with CT1812 compared to placebo-treated patients, and there are some very exciting findings that allow us to look at treating other diseases with our drugs in a very meaningful way.
PW: Congratulations again on this historic achievement. We’re always impressed by the groundbreaking research at Cognition Therapeutics, and we’re thrilled to see it being recognized by the scientific community.
Read more about Cognition Therapeutics – including the company’s origins, challenges they’ve encountered and how they’ve overcome them, and how Golden Seeds’ network has been valuable – in this earlier Q&A.