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Tiziana KOL Call Highlights Consistency Between Positive Phase 2a INFORM-MS Topline Results and Longer-Term Clinical Benefits Observed in Expanded Access Program for Patients with Non-Active Secondary Progressive Multiple Sclerosis Treated with Intranasal Foralumab

TLSA
  • Tiziana Life Sciences provided context on positive Phase 2a INFORM-MS trial results for intranasal foralumab, a fully human anti-CD3 monoclonal antibody, following a Key Opinion Leader call on November 9, 2026.
  • The 12-week placebo-controlled trial confirmed dual primary endpoint success, with the 50 μg dose arm showing a statistically significant reduction in microglial activation via [¹⁸F]PBR06 TSPO PET imaging (p=0.0168) compared to placebo.
  • Clinically meaningful improvements in fatigue were observed in both the 50 μg (–6.17 points, p=0.035) \& 100 μg (–7.18 points, p=0.040) dose arms using the Modified Fatigue Impact Scale, despite the study not being powered for this endpoint.
  • The 50 μg dose (n=19) was the primary arm powered for significance, while the 100 μg dose (n=11) was exploratory based on Phase 1 data indicating higher doses had reduced immunomodulatory effects.
  • Findings from the INFORM-MS trial correlate with long-term real-world data from the expanded access program, where patients treated for up to three years showed EDSS stabilization \& improvement in treatment-refractory non-active secondary progressive multiple sclerosis (na-SPMS).
  • Expanded access data from 10 patients demonstrated that all stabilized on EDSS scores, with three of four patients treated for 12 months showing improvement, \& seven of ten showing fatigue improvement after six months.
  • No anti-drug antibodies were detected in serum samples from expanded access patients, \& no study-drug-related serious adverse events occurred across more than 37.4 cumulative patient-years of exposure.
  • Foralumab demonstrated favorable safety \& tolerability as the first non-invasive anti-CD3 therapy, with trends toward reducing chronic neuroinflammation \& PIRA progression.
  • Non-active secondary progressive multiple sclerosis involves progression independent of relapse activity (PIRA), which drives long-term disability in approximately 70–90% of patients even when relapses are controlled.
  • There are currently no FDA-approved therapies specifically indicated for na-SPMS or the treatment of PIRA, representing a significant unmet need.
  • Tiziana plans to present detailed INFORM-MS findings at an upcoming scientific meeting \& intends to discuss next steps with the FDA regarding further clinical development.
Company
Tiziana Life Sciences Plc
Keywords
Nasdaq:TLSA, Tiziana Life Sciences Plc, KOL, Foralumab