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Tiziana reports positive Phase 2a INFORM-MS trial results for intranasal foralumab in non-active secondary progressive MS
TLSATiziana Life Sciences Ltd
Tiziana Life Sciences announced that its Phase 2a INFORM-MS trial of intranasal foralumab met dual primary endpoints: a statistically significant reduction (p=0.0168) in microglial activation measured by TSPO PET imaging and favorable safety/tolerability profiles across both the 50 μg and 100 μg dose arms. Secondary analysis showed clinically significant improvements in fatigue, with Modified Fatigue Impact Scale scores decreasing by -6.17 points (p=0.035) for the 50 μg group and -7.18 points (p=0.040) for the 100 μg group compared to baseline after 12 weeks of treatment. The company plans to engage with the FDA regarding future development pathways for this immunomodulation therapy in patients with non-active secondary progressive multiple sclerosis, a condition currently lacking approved treatments.