Tiziana Life Sciences Dosed First ALS Trial Patients

The Phase 2a clinical study is testing a novel monoclonal antibody treatment in patients with early-stage ALS.

Updated on Sept. 28, 2026 in Alzheimer’s

Bold flat-color editorial illustration of a medical nasal-delivery vial, rendered in a restrained geometric style representing clinical pharmaceutical research. — Tiziana Life Sciences has initiated a Phase 2a clinical trial in the U.S. to test the safety of foralumab, an experimental antibody treatment for early-stage ALS. AI Illustration. Upload story photo >

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Tiziana Life Sciences has begun dosing the first three participants in its BANYAN Phase 2a clinical trial for ALS. This study is testing the safety and tolerability of intranasal foralumab, a human anti-CD3 monoclonal antibody, in 44 individuals with early-stage disease.

Why it matters

The trial aims to determine if foralumab can modulate the Treg pathway in ALS patients, potentially offering a new therapeutic approach for the neurodegenerative condition. It uses biomarker-driven matching to identify specific patient subgroups that may benefit from the treatment.

The BANYAN trial enrolls 44 participants using a 3:1 randomization ratio of active drug to placebo. Key inclusion criteria include a minimum slow vital capacity of 65% and a neurofilament light chain level of at least 40 pg/mL.

The players

Tiziana Life Sciences

This is a biotechnology company focused on developing targeted therapies for autoimmune and inflammatory diseases.

ALS Association

This is a national non-profit organization that funds research and provides support services for those affected by ALS.

Sean M. Healey & AMG Center

This facility at Massachusetts General Hospital is a leading hub for multidisciplinary ALS research and clinical care.

The details

The study integrates genetic and plasma pNFL biomarkers to align patient subgroups with the experimental therapy. Administered via an intranasal route, the treatment involves 12 weeks of randomized medication followed by a 12-week active extension period.

September 28, 2026: The first three participants were successfully dosed.
October 1, 2026: The Sean M. Healey & AMG Center will host a community webinar.

The Big Picture

This development aligns with the BANYAN Phase 2a clinical trial as a pivotal step in investigating immunotherapy for neurodegenerative diseases. By testing monoclonal antibodies, researchers are extending the paradigm of precision medicine into the complex treatment landscape of ALS.

The study offers a new research avenue for patients with early-stage ALS who meet specific biomarker requirements. While the trial is currently limited to 44 participants, it provides a window into the potential for intranasal immunotherapy in future clinical care.

The takeaway

This trial underscores the shift toward personalized neurology by using pNFL biomarkers to match patients with specific therapies. Families affected by ALS should monitor upcoming webinar updates for new insights into the science of monoclonal antibody treatments.