Nasal Foralumab - (Healey ALS)

Sept. 28, 2026: Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) announced first dosing of the first three participants in the Phase 2a Healey ALS MyMatch BANYAN trial of intranasal foralumab for amyotrophic lateral sclerosis (ALS).

BANYAN is a 44-patient study in early ALS (≤24 months since symptom onset) with SVC ≥65% and neurofilament light chain (NfL) ≥40 pg/mL, randomized 3:1 to active drug or placebo. It includes a 12-week randomized controlled period followed by a 12-week active extension. The primary endpoint is safety and tolerability; secondary/exploratory endpoints include regulatory T-cell and T-cell subset profiling, single-cell RNA sequencing-based immunologic gene expression, changes in NfL, and microglial activation by TSPO-PET/MRI. The trial is sponsored by Tiziana, co-funded by the ALS Association, and is being run at Mass General Brigham with planned expansion to Northwestern, University of Minnesota, and Nova Southeastern (ClinicalTrials.gov: NCT07688239).

Upcoming catalyst: on Oct. 1, the Sean M. Healey & AMG Center and Tiziana will host a webinar on foralumab.

Other foralumab programs mentioned: a Phase 2a dose-ranging trial in non-active secondary progressive multiple sclerosis (NCT06292923), an expanded access program in na-SPMS (NCT06802328), and additional Phase 2 trials in Alzheimer’s disease and multiple system atrophy.