Coya Therapeutics Refines ALS Trial Stratification

The company introduced a new method to categorize trial participants by protein levels at the 2026 Annual NEALS Meeting.

Updated on Oct. 28, 2026 in Alzheimer’s

A close-up view of a glass pipette dispensing a clear drop into a laboratory vial, representing clinical research precision. — Coya Therapeutics introduced a new clinical trial stratification strategy using serum neurofilament light chain levels to better measure treatment outcomes in ALS patients. AI Illustration. Upload story photo >

Live Poll

Do you believe new research methods are successfully accelerating the development of treatments for neurodegenerative diseases?

Coya Therapeutics presented a new stratification strategy for ALS clinical trials using serum neurofilament light chain levels. This approach groups trial participants into tiers to better account for disease progression differences.

Why it matters

By grouping patients according to their baseline neurofilament light chain levels, researchers aim to reduce the impact of disease heterogeneity. This strategy is intended to improve the accuracy of measuring treatment outcomes in the ALSTARS Trial.

The ALSTARS Trial utilizes a 1:1:1 randomization process for 120 subjects across two COYA 302 dosing regimens and a placebo group. The study monitors efficacy and safety through a 24-week double-blind phase and a 24-week blinded extension phase.

The players

Coya Therapeutics

A biotechnology company headquartered in Houston that specializes in the development of treatments for neurodegenerative diseases.

The details

Neurofilament light chain is a structural protein released into the blood and cerebrospinal fluid as neurons suffer damage. Coya uses these protein levels to group trial participants into low, medium, and high tiers, which balances randomization and stabilizes the ALSFRS-R primary outcome measurement.

October 28, 2026: The stratification methodology was presented at the Annual NEALS Meeting.

Health Landscape

This methodology aims to enhance the clinical evaluation standards for ALSFRS-R by accounting for biological markers that vary significantly between individuals. It represents a shift toward more precise patient stratification in trials for neurodegenerative conditions.

Patients currently enrolled in the trial will be categorized based on their biomarker levels to potentially provide more accurate data on the efficacy of COYA 302. Those who complete the full 48-week period gain eligibility to transition into an open-label extension phase.

The takeaway

Stratification strategies like the one proposed by Coya represent a growing focus on managing the high variability found in neurodegenerative disease progression. These methods help ensure that clinical trial results more accurately reflect the true efficacy of experimental treatments.