In the latest episode of Business of Biotech, Milan Kalawadia, CEO of North America at Dr. Reddy’s Laboratories, and Arun Swaminathan, Ph.D., CEO of COYA Therapeutics (NASDAQ: COYA), discussed their partnership to develop and commercialize COYA 302, the company’s investigational lead candidate for ALS. The conversation highlighted how the collaboration came together, why it matters, and what it could mean for patients and investors.
Tackling ALS with an Innovative Approach
ALS is a devastating neurodegenerative disease with few treatment options. COYA 302 is a dual mechanism immunotherapy designed to slow progression by rebalancing immune regulation and reducing neuroinflammation.
“We want to make devastating neurodegenerative diseases livable diseases,” said Dr. Swaminathan. “With ALS, patients live three to five years after diagnosis, and in that time they decline rapidly. Nothing today slows this decline. Our approach is focused on stopping progression at its source by restoring regulatory T cell function.”
COYA 302 combines low-dose IL-2, which boosts the number and function of Tregs, with CTLA4-Ig, which suppresses inflammation from macrophages. Early investigator-led studies suggest the combination could deliver durable stabilization, an outcome not achieved by current therapies.
Why Dr. Reddy’s Backed COYA 302
For Dr. Reddy’s, a global pharmaceutical leader best known for generics and biosimilars, the partnership signals a deliberate move into innovative therapies.
“There’s always been a strong interest in innovative medicine at Dr. Reddy’s,” said Kalawadia. “When we looked at COYA 302, it aligned with our founder’s vision of launching an innovative asset. This is the next evolution of our journey as we move beyond generics and biosimilars into novel therapies.”
What began as a supply agreement for abatacept, one component of COYA 302, evolved into a full commercialization partnership. The scientific and regulatory expertise of COYA, combined with Dr. Reddy’s commercial scale and infrastructure, made the collaboration a natural fit.
Building for Approval and Market Entry
Both companies underscored the importance of working with regulators and preparing early for commercialization.
“Our priority is ALS,” said Dr. Swaminathan. “We want to get the trial started in 2025. The FDA has been very collaborative, and we have good alignment on trial design. If all goes well, we hope to advance into a Phase 2b study that could serve as the basis for approval given the high unmet need.”
Kalawadia added, “We have been very methodical in our approach. From marketing and analytics to market access and sales force design, we are preparing for biosimilars and for innovative assets like COYA 302. By the time this product is ready, we will have the capabilities in place to support a successful launch.”
Why Investors Should Pay Attention
This collaboration reduces risk for COYA by bringing commercial capabilities into play well before approval. It also provides Dr. Reddy’s with an entry point into innovative biologics for high unmet need diseases, creating value on both sides.
Dr. Swaminathan noted, “Our partnership enables us to advance the asset more efficiently and in a more rigorous manner. We now have the power of Dr. Reddy’s expertise alongside ours, and that is value creating.”
Near-Term Milestones That Could Drive Value
Coya is preparing for several catalysts in the months ahead. In Q2, the company submitted additional nonclinical data to the FDA to support initiation of its investigational lead candidate COYA 302 in a Phase 2 ALS trial, with a decision on the IND expected by or before August 29, 2025. A positive outcome could also trigger $8.4 million in milestone payments from Dr. Reddy’s. Beyond ALS, the company recently published research linking inflammation and oxidative stress to Parkinson’s disease progression and secured a U.S. patent for a stable, ready-to-use liquid IL-2 formulation with exclusive in-vivo rights across multiple indications. Looking ahead, the second half of 2025 is expected to bring ALS biomarker data, new proteomics results from an Alzheimer’s study, and topline readouts from trials in Frontotemporal Dementia and inflammatory models, along with an IND filing for COYA 302 in FTD before year-end.
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