Tiziana Life Sciences has announced the initiation of the Phase 2a Healey ALS MyMatch BANYAN trial of intranasal foralumab in people with amyotrophic lateral sclerosis. The company announced in November 2024 the ALS Association would fund a trial of intranasal foralumab in patients with ALS and in March 2025, the company said that it had submitted an IND for the Phase 2 study.
The BANYAN study is expected to enroll 44 patients with early ALS who will receive either intranasal foralumab or intranasal placebo delivered via an Aptar Unidose nasal delivery device. Dosing will take place in 8 cycles of 3 doses a week for 2 weeks followed by a week with no dosing.
Tiziana is developing intranasal foralumab for several other neurologic diseases, including secondary progressive multiple sclerosis (SPMS), multiple system atrophy, and Alzheimer’s disease. The company announced in 2025 that it had contracted with CDMO Renaissance Lakewood (now LTS) for development services.
Tiziana CEO Ivor Elrifi commented, “Dosing the first participants in the BANYAN Trial is a meaningful milestone for Tiziana and for the ALS community. ALS is a devastating disease with urgent unmet medical need. Our intranasal foralumab represents a differentiated, non-invasive, and convenient approach designed to modulate neuroinflammation by inducing regulatory T cells that traffic to the central nervous system. We are deeply grateful for the partnership with the Healey & AMG Center, the ALS Association, the outstanding investigators, and trial sites, and most importantly, the people living with ALS and families who make this progress possible. We look forward to generating important biomarker and safety data that can help advance the field.”
Principal Investigator of Healey ALS MyMatch and Co-Director of the Neurological Clinical Research Institute at Mass General Brigham Suma Babu said, “This study serves as a significant step in advancing the development of foralumab for ALS. The BANYAN trial is designed to answer important questions about foralumab, specifically, whether it has a biological effect on Treg pathway in ALS, as measured by biomarkers.”
Read the Tiziana Life Sciences press release
