Leen Kawas is the President and CEO of Athira Pharma. Read the Q&A below to learn more about why she chose to study Alzheimer’s and how she co-founded Athira.
WAM: Let’s start with who you are and what you’re doing – and why you think it is important?
Leen Kawas: I am one of four children in my family, the youngest of three daughters followed by a younger brother. We were all born and raised in Jordan, and eventually all of us immigrated to the U.S. for different reasons, but for me, it was to pursue a Ph.D. after practicing as a pharmacist in Jordan.
Today, I am the president and CEO of Athira Pharma, a company that I co-founded after my graduate studies, focused on a new approach to Alzheimer’s and other neurodegenerative diseases. Athira was founded in 2011 with a mission to develop meaningful therapies that will be available and accessible to all who are affected by Alzheimer’s and neurodegenerative diseases. After practicing as a pharmacist and witnessing how potentially cost-prohibitive medicines can be, I wanted to prioritize and focus our efforts on providing access to those who really need it and not just the top percentile who can afford it. Athira is now a company of over 30 people, and we have our first drug candidate in two late-stage clinical trials for Alzheimer’s disease.
WAM: What led you to work in this space? What inspires your work at Athira?
Leen Kawas: Worldwide Alzheimer’s prevalence is estimated to affect nearly 50 million people; almost everyone knows someone either directly or indirectly affected by this disease. I am no exception- my grandmother passed from Alzheimer’s as well, and experiencing the decline in her personality and ability to remember and think was devastating. It’s like a graying out of all the vibrant colors of the world around you. My inspiration to go into medicine, in part, stemmed from losing her, but also from my deep interest in science and motivation to want to find a cure for diseases, which I had from a young age.
I was fortunate my parents encouraged this interest, especially my mother. My mother also always encouraged my independent spirit and desire to challenge the norm, and she always made it a habit to tell me and my siblings that “the sky is not the limit.” It is due to her and my grandmother that I chose this path. I studied pharmacy in Jordan before deciding to pursue my Ph.D. in the U.S. I just needed to work on interesting science with real-life applications
Though my mother and grandmother were two of the driving forces behind my work in Alzheimer’s, today, I’m inspired by the work we’re doing at Athira: we are going after areas of serious unmet medical needs with speed and efficiency that many larger companies are typically incapable of. We’ve built a team that is very much aligned on our vision to develop meaningful therapies, thoughtfully and urgently, putting patients and caregivers at the forefront of every decision. In short, we are a passionate group of people working tirelessly towards the goal of increasing the quality of life for individuals with chronic illness.
WAM: Most of the Alzheimer’s therapies being developed today target the buildup of plaques and tangles, or amyloid and tau. Athira is coming at a treatment of the disease differently. Describe to us what you are doing and what the theory is behind your approach.
Leen Kawas: That’s right, over the past 20 years this field has been fixated on the plaques and tangles you mention- and most therapies have aimed to remove these protein buildups in the brain. One of the problems with this approach that we’ve learned over the years is that even though in some instances where these protein plaques are successfully removed, significant and meaningful improvements of Alzheimer’s related symptoms have not been consistently observed.
At Athira, we take a more holistic approach and think about Alzheimer’s as a disease of the brain network. Part of the network and what allows for effective communication between brain cells is due to the connection between brain cells, where when our brain cells cannot properly communicate with other brain cells (whether it is caused by tau, amyloid/beta, or something we do not fully understand yet) the result is cognitive decline and function. We want to facilitate communication between brain cells.
But instead of focusing on the protein pathologies, we aim to incite the restoration of existing connections and the growth of new connections. We’re encouraged by early data that demonstrates our investigational drug, ATH-1017, causes a rapid and immediate improvement in the signal of the brain that indicates brain network recovery. In this way, our therapy represents a new approach to treat Alzheimer’s disease, potentially targeting the root cause of memory decline by repairing brain cells and rebuilding brain networks.
WAM: As you know, two out of three cases of Alzheimer’s are women, and women also make up the majority of the caregivers in this country. Maria Shriver’s take on this is that because women are at the epicenter of the Alzheimer’s crisis, women must also be at the center of the solution. How do you and your company engage women as part of the solution to the Alzheimer’s crisis?
Leen Kawas: I love Maria’s quote about women as a critical part of the solution. Alzheimer’s is a disease that disproportionately affects women from multiple aspects—from incidence of the disease itself to caregiving—and we have sought to give those women a voice throughout every stage of our drug development process.
We interviewed those most intimately engaged with the disease on a daily basis—doctors, caregivers and patient advocates—about their daily struggles and their perceptions on what innovations could help ease the burden of life with Alzheimer’s. The majority of these interviews (as you would guess) were with women who shared with us their stories of grief, laughter, and loss in their Alzheimer’s journey, as well as their hope for a therapy that could one day make a difference. Their stories helped to inform our efforts and provided ever-constant encouragement as we pushed our therapeutic into later-stage trials.
As I consider women as critical to the Alzheimer’s solution, I am also reminded of all my fellow female leaders here at Athira. These include Glenna Mileson (our CFO) Xue Hua (our VP of Clinical Development, Research) and Julie Rathbun (our Head of Investor Relations) to name a few, whose efforts have been imperative to our achievements.
WAM: Where are you in terms of developing and testing the drug, and what have the results shown so far? What makes you hopeful that you may have a potential therapeutic?
Leen Kawas: Where we are today with our drug candidate is active testing of ATH-1017 in two late-stage clinical trials in mild to moderate Alzheimer’s patients. We can’t speak to what the results have been in our current studies as those are still ongoing and the trials are blinded, but in our early-stage Phase 1 clinical trials, we also tested ATH-1017 in a small cohort of Alzheimer’s patients. Though the number of Alzheimer’s patients was very small, the full trial included 88 total individuals from healthy young to healthy elderly to Alzheimer’s patients. Phase 1 trials assess the safety of drug candidates. I’m pleased to share that there were no serious adverse events with those that received ATH-1017 when compared to placebo.
In addition to assessing for safety, we also incorporated a functional measure of brain network and memory processing. This ties directly to our approach of helping to repair and regenerate the brain network. Though we only evaluated a small number of Alzheimer’s patients, we saw a directional improvement in each of the Alzheimer’s patients in this measure, demonstrating an improvement in total brain network and memory processing. What’s additionally encouraging is that this functional measure has been directly correlated with other measures that the Food and Drug Administration (FDA) has used to assess the efficacy of other approved Alzheimer’s drugs like donepezil and rivastigmine.
Because of these encouraging results from our early-stage Phase 1 studies, we are eagerly anticipating the completion of our two late-stage clinical trials to see if what we saw early on will carry over into these late-stage trials and demonstrate an improvement in cognitive function for Alzheimer’s patients.
WAM: Tell us more about your clinical trial. Who would the ideal candidate be and where can they find more information?
Leen Kawas: Today, we have two late-stage clinical trials, LIFT-AD and ACT-AD, both are underway to evaluate our investigational drug candidate, ATH-1017 in Alzheimer’s. Both trials are actively enrolling patients with mild to moderate Alzheimer’s across the United States and Australia. Participation in the study takes about eight months, including approximately six months of treatment duration. Both trials are evaluating if ATH-1017 is safe and effective in improving symptoms of mild to moderate Alzheimer’s disease.
Interested parties may be eligible if they are between 55 and 85 years of age, have been diagnosed with Alzheimer’s disease, and have a reliable support person or caregiver who is willing to participate in study visits, report on daily activities and oversee or help the participant with the administration of ATH-1017.
To learn more or get involved in a study, please visit athiraclinicaltrials.com, email clinicaltrials@athira.com or call 1-800-668-4717 in the US or +61 1800-043212 in Australia.