Tiziana Completes Enrollment in Phase 2a Trial of Intranasal Foralumab for na-SPMS

2026-05-21SEC Filing 6-K (0001213900-26-059919)

Tiziana Life Sciences LTD (Nasdaq: TLSA) has announced the completion of patient enrollment for its Phase 2a clinical trial (INFORM-MS) evaluating intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). Foralumab is a fully human anti-CD3 monoclonal antibody designed to modulate the immune system and address neuroinflammation. The randomized, double-blind, placebo-controlled multicenter study enrolled 48 patients across various U.S. sites. Participants received one of two doses of foralumab or a placebo over a 12-week treatment period. The trial also includes a six-month open-label extension (OLE) phase to assess long-term safety and sustained benefits. Assessments include PET imaging for microglial activation, MRI, and clinical biomarkers. This study marks the first placebo-controlled trial of intranasal foralumab for neurodegenerative diseases. The company expects to release topline data in late Q3 2026 and plans to present the results at the joint ACTRIMS-ECTRIMS meeting in October 2026.

Ticker mentioned:TLSA