Biotech Company Reports Promising Neurological Treatment in Clinical Study

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Clinical-stage biotechnology company Coya Therapeutics Inc. (COYA:NASDAQ) announced positive interim results of an investigator-initiated proof of concept open-label study with a low-dose IL-2 and CTLA4-Ig combination treatment in patients with frontotemporal dementia (FTD).

Patients participated in 22 weeks of dosing and follow-up. The study aims to enroll up to 10 patients, and these interim results include data from the first five patients with mild to moderate FTD who have completed the full course of treatment, the company said in a release on Thursday.

"The results thus far are consistent with previously published encouraging data from an open-label investigator-initiated study of patients with ALS treated with low-dose IL-2/CTLA4-Ig," said Coya Chief Executive Officer Dr. Arun Swaminathan. "This interim data in FTD provides us further confidence of our approach to target and enhance Treg biology to address devastating neurodegenerative diseases including ALS and FTD."

According to previous biomarker data presented by the company, Coya said FTD patients exhibit a compromised immunosuppressive function of regulatory T cells (Tregs), along with increased peripheral levels of inflammatory cytokines and chemokines, dysregulation of monocytes, and systemic activation of the inflammatory cascade, supporting the critical role of the immune system in the pathophysiology of FTD.

A previous study showed that a cohort of 68 patients with FTD worsened by an average of 3.57 points over a 12-month period on a clinical dementia rating scale. Patients with FTD also typically have shorter survival times and more rapid rates of cognitive and functional decline compared to patients with Alzheimer's disease, the company said.

"We are excited with the results observed in this initial group of patients with this proof-of-concept study," said Coya Chief Medical Officer Dr. Fred Grossman. "We believe that the increase in Treg numbers and suppressive function, with subsequent anti-inflammatory biological activity still to be evaluated, underscores the potential for this low-dose IL-2/CTLA4-Ig combination to be further studied as a therapy for FTD, for which there are no currently approved treatments."

Several Key Milestones This Year

Also on Thursday, D. Boral Capital analyst Jason Kolbert maintained a Buy rating and a US$18.00 price target on Coya following the company's announcement on the FTD study.

The treatment's mechanism of action is based on a combination therapy approach using low-dose interleukin-2 (IL-2) and CTLA4-Ig to modulate the immune system, reduce neuroinflammation, and promote neuroprotection.

D. Boral Capital analyst Jason Kolbert maintained a Buy rating and a US$18.00 price target on Coya following the company's announcement on the FTD study.

Low-dose IL-2 selectively expands and activates Tregs, which play a critical role in maintaining immune homeostasis by suppressing inflammatory responses and inhibiting the release of neurotoxic cytokines, the analyst noted. CTLA4-Ig (Abatacept) acts as an immune checkpoint inhibitor that binds to CD80 and CD86 on antigen-presenting cells, preventing activation of T cells and dampening excessive immune responses. Together, these components create a synergistic effect by enhancing Treg-mediated suppression of inflammation while simultaneously inhibiting pro-inflammatory immune pathways.

Looking ahead, Coya Therapeutics anticipates several key milestones for the year, including submitting a data package to the FDA for a Phase 2 study of COYA 302 in patients with Amyotrophic Lateral Sclerosis (ALS) by the second quarter.

Additionally, Coya expects to report topline results from the ongoing open-label study of low-dose IL-2 and CTLA4-Ig in Frontotemporal Dementia in the second half of the year, Kolbert said.

The Catalyst: A Leading Cause of Illness, Disability

Brain disease is a global issue with more than 1 in 3 people around the world affected by neurological conditions, making it "the leading cause of illness and disability worldwide," the American Brain Foundation said.

Based on 2021 data from the Global Burden of Disease, Injuries, and Risk Factor Study (GBD), the findings indicate that the overall amount of disability, illness, and premature death (known as disability-adjusted life years, DALYs) caused by neurological conditions has increased by 18% since 1990.

The 10 neurological conditions with the greatest DALYs were stroke, neonatal encephalopathy (neurological dysfunction in an infant at or around delivery), migraine, Alzheimer’s disease and other dementias, diabetic neuropathy (nerve damage as a symptom of diabetes), meningitis, epilepsy, neurological complications due to preterm birth, autism spectrum disorder, and nervous system cancer.

The neurodegenerative disease market size is estimated at US$59.06 billion in 2025, and is expected to reach US$83.37 billion by 2030, at a compound annual growth rate (CAGR) of 7.14% during the forecast period (2025-2030), Mordor Intelligence said.

"The key growth determinants of the market include the increasing number of neurological disorders, growing awareness globally, and a strong lineup of products for treating neurodegenerative diseases," researchers said. "As the global population grows and people live longer on average, more people are experiencing neurological disorders."

Around 6.2 million Americans had Alzheimer's disease as of June 2022, according to data from the National Institute of Environmental Health Sciences, Mordor reported.

"A study published in the Lancet Journal in March 2024 showed that neurological disorders contribute to 3.4 billion disability-adjusted life-years (DALYs) worldwide," Mordor said. "This high burden of neurological disorders is anticipated to increase the demand for treatments and effective methods, driving growth in the neurodegenerative disease market."

Ownership and Share Structure

According to Refinitiv, about 1% of the company is owned by insiders and management, while institutions own 27% and strategic entities own 6%. The rest is retail.

Top shareholders include Greenlight Capital Inc. with 9.84%, Bertex LLC with 5.62%, AIGH Capital Management LLC with 5.33%, The Vanguard Group Inc. with 5.03%, and Worth Venture Partners LLC with 1.85%.

Its market cap is US$109.21 million with 16.72 million shares outstanding. It trades in 52-week range of US$4.65 and US$10.24.