Foralumab - (INFORM-MS)

May 21, 2026: Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) announced completion of patient enrollment in its randomized, double-blind, placebo-controlled Phase 2a trial (INFORM‑MS; NCT06292923) evaluating intranasal foralumab (fully human anti‑CD3 mAb) in non-active secondary progressive multiple sclerosis (na‑SPMS). The multicenter U.S. study enrolled 48 patients to receive one of two intranasal dose levels or placebo for 12 weeks, with assessments including PET imaging for microglial activation, MRI, clinical evaluations, and biomarkers. After the blinded period, all participants may enter a six-month open-label extension to evaluate longer-term safety and sustained benefit.

Topline data are expected in late Q3 2026 and are also planned for presentation at the ACTRIMS-ECTRIMS meeting in Toronto in October 2026.

The release also notes an expanded access program (NCT06802328) in which 14 na‑SPMS patients have been dosed, with improvement or stability within 6 months reported in all patients (as described by the company).