• Top line data readout expected in late Q3/early Q4
     
  • INFORM-MS trial is a randomized, double-blind, placebo-controlled Phase 2a trial using Intranasal Foralumab in patients with Non-Active Secondary Progressive Multiple Sclerosis

BOSTON, June 25, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (NASDAQ:TLSA) ("Tiziana"), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces that the last patient in its ongoing Phase 2a clinical trial has received their first dose of intranasal foralumab for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS). Topline data is expected in late Q3/early Q4 of 2026, and is planned to be presented at the 10th joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and ECTRIMS meeting in Toronto, Canada in October 2026.

The randomized, double-blind, placebo-controlled Phase 2a trial, known as INFORM-MS (NCT06292923), is evaluating the safety, tolerability, and efficacy of two doses of intranasal foralumab versus placebo in up to 48 patients with na-SPMS. The study includes multiple U.S. investigational sites and focuses on both imaging biomarkers and clinical outcomes.

Final dosing is underway across multiple leading U.S. clinical sites, including Brigham and Women’s Hospital, Johns Hopkins University, Weill Cornell Medicine, Yale MS Center, and others. The primary endpoint of the trial is the change in microglial activation as measured by positron emission tomography (PET) scans, with additional clinical evaluations including the Expanded Disability Status Scale (EDSS), quality of life assessments, and the Modified Fatigue Impact Scale (MFIS).