Tiziana doses first ALS patients with intranasal foralumab in BANYAN trial

Tiziana's news for the week centers on a dosing milestone in its ALS program for foralumab.

• Intranasal foralumab, Tiziana's anti-CD3 monoclonal antibody, moved forward in ALS after the company said the first three participants received their first dose in the Phase 2a Healey ALS MyMatch BANYAN clinical trial¹. The trial plans to enroll 44 individuals with early ALS, defined as no more than 24 months since symptom onset, slow vital capacity of at least 65%, and neurofilament light chain of at least 40 pg/mL¹, with safety and tolerability of foralumab as the primary endpoint¹.
• The study is run by Tiziana as sponsor, with co-funding from the ALS Association under its Hoffman ALS Clinical Trial Awards Program¹.
• In multiple sclerosis, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis have been dosed in an open-label Expanded Access Program, with improvement or stability of disease seen within 6 months in all patients¹. A separate Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in non-active secondary progressive multiple sclerosis is also ongoing¹.