Trethera Collaborates with MGH to Evaluate ALS Treatment

Biopharmaceutical company partners with leading research hospital to test investigational therapy TRE-515 in advanced ALS patients.

Mar. 31, 2026 at 3:27pm

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A ghostly, translucent X-ray photograph revealing the intricate internal structure of a human nerve cell, conceptually representing the impact of ALS on the nervous system.An X-ray view into the complex neural networks affected by the devastating ALS disease, highlighting the need for new therapeutic approaches.Boston Today

Trethera Corporation, a clinical-stage biopharmaceutical company, has announced a collaboration with Massachusetts General Hospital (MGH) to evaluate its investigational therapy TRE-515 in up to six patients with advanced amyotrophic lateral sclerosis (ALS) under the FDA's Expanded Access program. TRE-515 inhibits a key enzyme involved in inflammation, which is believed to contribute to ALS. The trial will assess the safety and tolerability of TRE-515 while tracking disease progression and collecting biomarker data.

Why it matters

Therapeutic options for ALS remain limited, and there is a continuing need to explore novel approaches for patients facing this devastating neurodegenerative disease. This collaboration with the renowned ALS research center at MGH represents an important step in Trethera's efforts to develop new treatments for ALS.

The details

The trial will be led by Dr. Merit Cudkowicz, Executive Director of the Massachusetts General Brigham Neuroscience Institute and a leading expert in ALS clinical research. Patients will undergo monthly assessments of their disease progression and provide biomarker samples to help inform the biological activity of TRE-515 and guide future clinical development. Trethera previously reported encouraging results from a single-patient case study of TRE-515 in advanced ALS, which suggested the potential to stabilize disease progression.

  • The clinical collaboration was announced on March 31, 2026.
  • Up to six patients with advanced ALS will be enrolled in the trial conducted by MGH.

The players

Trethera Corporation

A clinical-stage biopharmaceutical company developing first-in-class therapies for cancer, autoimmune, and neuroimmune diseases.

Massachusetts General Hospital (MGH)

The original and largest teaching hospital of Harvard Medical School, internationally recognized as a leading ALS research center.

Dr. Ken Schultz

Trethera's Chairman and CEO.

Dr. Merit Cudkowicz

Executive Director of the Massachusetts General Brigham Neuroscience Institute and principal investigator for the trial.

Dr. Lawrence Steinman

Member of Trethera's Scientific Advisory Board and Professor of Neurology at Stanford University.

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What they’re saying

“This collaboration with MGH follows our encouraging ALS clinical findings last year and is an important step in expanding our clinical efforts to understand and treat this devastating disease.”

— Dr. Ken Schultz, Trethera Chairman and CEO

“Therapeutic options for ALS remain limited, and there is a continuing need to explore novel approaches for patients facing this serious disease.”

— Dr. Merit Cudkowicz, Executive Director of the Massachusetts General Brigham Neuroscience Institute

“We are particularly encouraged by the potential of treating ALS with TRE-515 given its ability to selectively modulate inflammation and its favorable safety profile observed to date.”

— Dr. Lawrence Steinman, Member of Trethera's Scientific Advisory Board and Professor of Neurology at Stanford University

What’s next

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The takeaway

This collaboration between Trethera and MGH represents a promising step forward in the search for new treatments for the devastating ALS disease, which continues to have limited therapeutic options available.