ALS Trial Tested New Nasal Antibody Treatment
Researchers have started a Phase 2a trial of intranasal foralumab to evaluate its safety and potential for adults with early ALS.
Updated on Sept. 28, 2026 in Alzheimer’s
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Tiziana Life Sciences has dosed the first three participants in the BANYAN clinical trial, a study investigating the safety of the monoclonal antibody foralumab in 44 individuals with early ALS. This Phase 2a study, co-funded by the ALS Association, marks a new step in testing non-invasive delivery methods for potential ALS therapies.
Why it matters
This trial aims to determine if foralumab can modulate the Treg pathway, potentially offering a new approach to managing the biological drivers of ALS. By integrating genetic and plasma biomarker testing, researchers are attempting to match specific patient subgroups to this investigational therapy.
The BANYAN trial is a Phase 2a study enrolling 44 individuals with early-stage ALS. The protocol uses a 3:1 randomization ratio to compare the safety and tolerability of intranasal foralumab against a placebo over an initial 12-week treatment period.
The players
Tiziana Life Sciences
A biotechnology company focused on developing monoclonal antibodies for autoimmune and inflammatory diseases.
ALS Association
A national nonprofit organization that funds research, provides care services, and advocates for people living with amyotrophic lateral sclerosis.
Sean M. Healey & AMG Center
A clinical research facility dedicated to accelerating the development of therapies for ALS patients.
The details
Foralumab is a human anti-CD3 monoclonal antibody designed to influence immune system activity through the Treg pathway. Unlike systemic treatments, this drug is administered via an intranasal route to potentially access the central nervous system more directly. The trial incorporates pNFL genetic and plasma biomarker screening to help identify if specific subgroups are more responsive to this modulation.
Timeline
September 28, 2026: The first three participants were dosed in the clinical trial.
October 1, 2026: The Sean M. Healey & AMG Center will host a community webinar on the study science.
Health Landscape
This study follows the research model established by the Sean M. Healey & AMG Center to find biological pathways that address the progression of ALS. It represents a shift toward biomarker-driven trial designs that aim to match patients to experimental immunomodulatory treatments.
The BANYAN trial is currently focused on safety, and potential participants should consult with their neurologist about whether they meet the specific criteria for future enrollment, such as disease onset and biomarker levels. It is important to speak with your doctor to understand if participating in a clinical trial is a suitable option for your specific health situation.
The takeaway
This trial highlights the ongoing effort to find new ways to modulate the immune system in early ALS. If you are interested in research, keep track of enrollment updates through the clinical trial registry using the identifier NCT07688239.
What happens next
The Sean M. Healey & AMG Center will host a community webinar regarding the science of foralumab on October 1, 2026.
Further reading
Learn more about the latest research and ongoing developments in the field by visiting our Alzheimer’s section.
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