Tiziana Life Sciences doses first ALS patients in Phase 2a Foralumab trial

Tiziana Life Sciences CEO Ivor Elrifi joined Steve Darling from Proactive to announce an important milestone in the company’s neuroimmunology pipeline, with the first three participants receiving their initial doses of intranasal foralumab in the Phase 2a Healey ALS MyMatch BANYAN clinical trial.
The study is evaluating intranasal foralumab as a potential treatment for amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease that damages nerve cells responsible for controlling voluntary muscle movement. The BANYAN trial is sponsored by Tiziana Life Sciences and co-funded by the ALS Association through its Hoffman ALS Clinical Trial Awards Program.
Elrifi said the dosing of the first participants represents an important step in advancing the clinical development of foralumab and supports Tiziana’s broader strategy of investigating therapies designed to target neuroinflammatory mechanisms that may play a role in neurological diseases.
The Phase 2a study is initially being conducted at the Sean M. Healey & AMG Center for ALS at Mass General Brigham in Boston. The company expects the trial to expand to additional clinical sites, including Northwestern Medicine’s Les Turner ALS Center in Chicago, the University of Minnesota in Minneapolis and Nova Southeastern University in Florida.
BANYAN is expected to enroll 44 people with early-stage ALS who meet specific clinical and biomarker criteria. Participants must have experienced symptom onset within the previous 24 months, have a slow vital capacity of at least 65%, and demonstrate elevated levels of neurofilament light chain (NfL) of 40 pg/mL or greater.
Participants will be randomized in a 3-to-1 ratio to receive either intranasal foralumab or placebo during a 12-week controlled treatment period. This will be followed by a 12-week extension phase during which all participants will receive active treatment.
The primary objective of the study is to assess the safety and tolerability of intranasal foralumab in people with ALS. Investigators will also evaluate a series of secondary and exploratory endpoints intended to provide additional information on the treatment’s biological activity and its potential effects on disease-related biomarkers.
As enrollment and treatment continue, Tiziana expects the BANYAN study to generate additional data on the safety profile and immunological activity of intranasal foralumab in ALS patients. The company says the research could also contribute to a broader understanding of how modulation of the immune system may influence processes associated with neurodegenerative disease.
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