Tiziana Completes Dosing of 48-Patient Phase 2a na-SPMS Trial, Data Due Q3/Q4
TLSA•Tiziana reports last of 48 patients dosed in Phase 2a INFORM-MS trial evaluating two doses of intranasal foralumab versus placebo in non-active secondary progressive multiple sclerosis across leading US centers. Topline data are expected in late Q3/early Q4 2026 with presentation planned at the October ACTRIMS-ECTRIMS meeting in Toronto.
1. Phase 2a Dosing Milestone
Tiziana has completed dosing of the final patient in its Phase 2a INFORM-MS trial, enrolling 48 non-active secondary progressive MS patients across multiple US clinical sites including Brigham and Women’s, Johns Hopkins and Yale.
2. Trial Design and Endpoints
The randomized, double-blind, placebo-controlled trial compares two intranasal foralumab doses against placebo, measuring microglial activation via PET scans and clinical outcomes such as EDSS, quality of life and fatigue scales over a 12-week treatment period.
3. Upcoming Data Readout and Presentation
Topline safety, tolerability and efficacy data are expected in late Q3 or early Q4 2026, with results slated for presentation at the October ACTRIMS-ECTRIMS meeting in Toronto.
4. Intranasal Foralumab Advantages
Intranasal foralumab, the only fully human anti-CD3 mAb in clinical development via nasal delivery, aims to modulate immune responses directly in the nasal mucosa with potential CNS effects, offering a novel approach for neuroinflammatory diseases.
