PRISM Q&A CORNER
Arun Swaminathan, Coya Therapeutics
Advancing COYA 302 for ALS with Patient-Centered Vision
Neurodegeneration is one of the world’s most urgent health challenges. More than 50 million people are affected worldwide, and one in three individuals will be impacted by a neurological condition in their lifetime. Dementia alone is projected to cost $9 trillion globally by 2050. For patients with amyotrophic lateral sclerosis (ALS), life expectancy remains only three to five years after diagnosis.
These progressive conditions, which include ALS, Alzheimer’s disease, Parkinson’s disease, and frontotemporal dementia (FTD), impair movement, memory, and thinking, with limited therapeutic pathways available today.
Coya Therapeutics (NASDAQ: COYA) is working to address neurodegeneration at its source by developing innovative therapies aimed at common underlying mechanisms of these diseases. Its lead investigational candidate, COYA 302, is designed to harness the power of regulatory T cells (Tregs), the immune system’s “first responders,” to restore balance and reduce damaging inflammation. By combining therapeutic approaches, Coya’s vision is to deliver treatments that can meaningfully improve quality of life across multiple neurodegenerative conditions.
The FDA’s recent acceptance of Coya’s Investigational New Drug (IND) application for COYA 302 marks a pivotal moment for the company, paving the way for a Phase 2 trial in ALS.
PRISM MarketView sat down with Arun Swaminathan, CEO of Coya Therapeutics, to discuss the importance of this milestone, what it means for ALS patients, and how the company is positioning itself within the global effort to tackle neurodegenerative disease.
This is a pivotal moment for Coya Therapeutics. The FDA’s acceptance of our IND for COYA 302 enables us to move forward with our planned Phase 2 study, which will be a multi-center, double-blind, placebo-controlled trial in ALS. Given the nature of ALS and the precedent in this space, a single well-designed trial like this has the potential to be considered registrational, which means it could ultimately serve as the basis for approval.
For patients, this is an important step toward new treatment options in a disease that today has very limited therapies and a devastating impact on quality of life.
Our immediate focus is on initiating the trial as quickly and efficiently as possible. There are multiple steps involved, from site activations to patient screening and enrollment, many of which could only proceed once the IND was cleared. We are fully committed to reaching the first patient dosing this year.
Strategic partnerships are essential to our progress. Our collaboration with Dr. Reddy’s Laboratories is a prime example. They hold commercial rights for COYA 302 in ALS, while Coya retains rights for all other indications, as well as ALS rights in Japan, South America, and Mexico. Beyond financial support, the partnership includes $8.4 million in near-term milestone payments. The first $4.2 million payment has already been received following IND acceptance, and the second $4.2 million will come when we initiate dosing of the first patient in our Phase 2 ALS trial. The partnership also brings deep expertise in manufacturing, regulatory pathways, and commercialization.
In addition, our partnerships with the Alzheimer’s Drug Discovery Foundation and Houston Methodist continue to strengthen our programs in frontotemporal dementia and reinforce the scientific foundation that drives our work. At Coya, we are very deliberate about partnering where we can create synergies that make the whole greater than the sum of the parts, always with the patient as our focus.
The first IND is always the most challenging, because it requires the full package of preclinical toxicology, as well as Chemistry, Manufacturing, and Controls (CMC), and other foundational data. Now that the FDA has reviewed and accepted this data for COYA 302, it makes future IND submissions more efficient. We plan to submit an IND for frontotemporal dementia later this year, and most of the supporting package will be the same as what was already reviewed for ALS. This efficiency helps us move faster across multiple indications, which is important given the broad potential of our platform.
COYA 303 remains an important priority for us. It combines low-dose interleukin-2 with GLP-1 agonists, such as semaglutide, and we see strong synergistic potential. GLP-1s alone have already shown signs of slowing cognitive decline in retrospective studies, and we believe combining them with our Treg-based approach can deliver even more meaningful benefit. Preclinical work is ongoing, and we look forward to sharing additional data in the months ahead. This program not only has strong scientific potential but also opens doors for business development opportunities, given the size and visibility of the GLP-1 market.
Beyond ALS, we expect additional data from an investigator-initiated trial in frontotemporal dementia, further biomarker readouts in both Alzheimer’s and ALS, and new preclinical data from our COYA 303 program. Finally, before the end of the year, we plan to submit an IND to support a Phase 2 study in frontotemporal dementia, with trial initiation expected in 2026.
The ALS community is highly engaged, and their voice is central to everything we do. Many of us at Coya have been personally touched by neurodegenerative diseases, so there is a deep sense of purpose behind our work. Patients are our North Star. We believe that when we do what is right for patients, shareholder and corporate value will follow.
Our vision is to make diseases like ALS, FTD, and Alzheimer’s livable conditions. We want patients to be known for their accomplishments, their families, and their passions, rather than being defined by their diagnosis. That is the future we are working toward, and it drives our team every day.
