Tiziana Completes 48-Patient Enrollment in Phase 2a na-SPMS Trial
Tiziana Life Sciences has completed enrollment of 48 patients in its placebo-controlled Phase 2a INFORM-MS trial evaluating intranasal foralumab in non-active secondary progressive MS over a 12-week treatment period with six-month open-label extension. Topline data are due late Q3 2026 and will be presented at October’s ACTRIMS/ECTRIMS meeting.
1. Enrollment Completion
Tiziana Life Sciences has announced full enrollment of 48 patients in its Phase 2a INFORM-MS trial, marking the first placebo-controlled study of intranasal foralumab in non-active secondary progressive multiple sclerosis (na-SPMS). This milestone enables the study to proceed to data collection and subsequent analysis without further recruitment delays.
2. Trial Design
The randomized, double-blind trial assigns participants to one of two intranasal foralumab dose arms or placebo over a 12-week treatment period. Efficacy and safety assessments include PET imaging for microglial activation, MRI scans, clinical evaluations, and biomarker analyses across multiple U.S. sites.
3. Upcoming Data and Presentation
Topline efficacy and safety data are slated for release in late Q3 2026, providing the first controlled evidence of intranasal foralumab’s impact on neuroinflammation in na-SPMS. Results will be disclosed at the 10th joint ACTRIMS/ECTRIMS meeting in Toronto in October 2026.
4. Six-Month Open-Label Extension
After the blinded phase, all participants—including those on placebo—can enroll in a six-month open-label extension to receive intranasal foralumab. This extension aims to evaluate long-term safety and sustained therapeutic benefit in the na-SPMS population.