Tiziana Doses First ALS Patients in Phase 2a BANYAN Trial of…

Event summary

First three ALS patients dosed in Phase 2a BANYAN trial of intranasal foralumab on September 28, 2026.
Trial sponsored by Tiziana and co-funded by the ALS Association, enrolling 44 early-stage ALS patients.
Primary endpoint focuses on safety and tolerability, with secondary endpoints tracking immune and biomarker changes.
Trial led by Suma Babu and James Berry at the Healey & AMG Center in Boston.

The big picture

Tiziana’s BANYAN trial represents a strategic pivot toward biomarker-driven ALS research, aligning with broader industry shifts toward personalized neurotherapeutics. The intranasal delivery of foralumab offers a non-invasive alternative to traditional IV therapies, potentially expanding treatment accessibility. Success in this trial could validate Tiziana’s immunomodulation platform for broader neurodegenerative applications.

What we're watching

Biomarker Validation: Whether foralumab demonstrates measurable effects on Treg pathways and neurofilament light chain levels in ALS patients.
Trial Execution: The pace at which the 44-patient trial enrolls and generates interim safety and biomarker data.
Strategic Differentiation: How Tiziana positions intranasal foralumab against competing neuroinflammatory therapies in ALS and other neurodegenerative diseases.