Clinical TrialNov 2, 2026, 07:01 AM
Tiziana Life Sciences: Foralumab Trial Meets Primary Endpoints in MS
AI Summary
Tiziana Life Sciences announced positive topline results from its Phase 2a INFORM-MS trial for intranasal foralumab in non-active secondary progressive multiple sclerosis. The trial met its dual primary endpoints, demonstrating a statistically significant reduction in neuroinflammation (microglial activation) as measured by TSPO PET imaging in patients treated with 50 ug of foralumab compared to placebo. Additionally, the treatment was found to be safe and well-tolerated. Patients treated with foralumab also showed statistically significant and clinically significant improvements in fatigue scores, as measured by the Modified Fatigue Impact Scale (MFIS), after 12 weeks of therapy.
Key Highlights
- Tiziana Life Sciences' Phase 2a INFORM-MS trial met dual primary endpoints for intranasal foralumab in multiple sclerosis.
- Statistically significant reduction (p=0.0168) in microglial activation observed with 50 ug nasal foralumab vs placebo.
- Foralumab-treated subjects showed statistically significant improvements in Modified Fatigue Impact Scale (MFIS) scores.
- 50 ug dose showed a -6.17 point decrease in MFIS from baseline (p=0.035); 100 ug showed -7.18 (p=0.040).
- Intranasal foralumab demonstrated safety and tolerability across both 50 ug and 100 ug doses.
- Trial enrolled 40 patients randomized to placebo (n=18), 50 ug (n=19), or 100 ug (n=11) for 12 weeks.
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