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Tiziana to Host Investor Call with Key Opinion Leaders to Discuss Positive Phase 2a INFORM-MS Topline Results

TLSA
  • Tiziana Life Sciences announced positive topline results from the Phase 2a INFORM-MS trial of intranasal foralumab in patients with non-active secondary progressive multiple sclerosis (na-SPMS).
  • The trial met its primary endpoint with a statistically significant reduction in microglial activation on TSPO PET imaging in the 50 μg dose arm (p=0.0168).
  • Clinically meaningful & statistically significant improvements in fatigue were observed in both foralumab dose arms after 12 weeks, with MFIS score decreases of -6.17 (50 μg) & -7.18 (100 μg).
  • Intranasal foralumab demonstrated a favorable safety & tolerability profile with no study-drug related serious adverse events & all 48 participants completing treatment.
  • The 50 μg dose is identified as the optimal dose for statistical significance, while the 100 μg dose showed exploratory variance in PET outcomes compared to the 50 μg dose.
  • The company plans to complete full data analysis, present detailed results at an upcoming scientific congress, & engage with the FDA regarding next clinical development steps.
  • A conference call featuring Key Opinion Leaders will be held on November 9, 2026, to discuss the dual primary endpoint results & secondary clinical findings.
  • Foralumab remains the only fully human anti-CD3 monoclonal antibody in clinical development & represents a non-invasive alternative to intravenous therapies.