Tiziana Life Sciences Ltd (NASDAQ:TLSA) said the last patient in its Phase 2a clinical trial has received a first dose of intranasal foralumab for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS), with topline data expected in late Q3 or early Q4 2026.
The company said results are planned to be presented at the 10th joint ACTRIMS-ECTRIMS meeting in Toronto in October 2026.
The randomized, double-blind, placebo-controlled study is evaluating the safety, tolerability, and efficacy of two doses of intranasal foralumab versus placebo in up to 48 patients with na-SPMS. Final dosing is underway across multiple US sites, including Brigham and Women's Hospital, Johns Hopkins University, Weill Cornell Medicine, and Yale MS Center.
The trial's primary endpoint is change in microglial activation as measured by positron emission tomography scans. Additional evaluations include the Expanded Disability Status Scale, quality of life assessments, and the Modified Fatigue Impact Scale.
Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development delivered intranasally. The route of administration aims to target immune modulation in the nasal passages, with potential effects on the central nervous system.
"We are thrilled to reach this important milestone in our Phase 2 program," said CEO Ivor Elrifi. "The successful initiation of dosing in all patients underscores the strong execution by our clinical teams and the enthusiasm from investigators and patients for this novel intranasal approach."
Tiziana said it will continue monitoring patients through the 12-week treatment period and open-label extension.