Tiziana Life Sciences reported positive topline results on November 2, 2026, from its Phase 2a INFORM-MS trial of intranasal foralumab in non-active secondary progressive multiple sclerosis (na-SPMS).
The trial’s neuroinflammation endpoint showed a statistically significant reduction in the 50 μg dose group versus placebo after 12 weeks, measured using TSPO PET imaging (p=0.0168). The 100 μg dose did not show a statistically significant imaging difference.
Both doses were reported as generally safe and well tolerated. All 48 participants completed the trial; reports said there were no drug-related serious adverse events or withdrawals due to adverse events.
Fatigue scores improved from baseline in the foralumab groups:
6.17 points with 50 μg and 7.18 points with 100 μg. These are encouraging secondary findings, but disability scores did not show improvement over the 12-week period.
The results are preliminary topline data from a small Phase 2a study. The dose-specific efficacy difference and lack of disability improvement mean larger, longer studies will be needed to establish clinical benefit.
Sources:
Tiziana Life Sciences LTD Press Release, dated ...
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