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Tiziana Announces New Positive Clinical Data for Intranasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis

TLSA
  • Tiziana Life Sciences announced updated clinical data from its Expanded Access Program for intranasal foralumab in 14 patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS) as of March 2026.
  • The treatment demonstrated an extremely well-tolerated safety profile over extended durations with no new safety signals identified.
  • Data indicated favorable trends in disability stabilization, showing reduced Confirmed Disability Progression (CDP) compared to the HERCULES Phase 3 trial reference arms.
  • 64% of patients (9 out of 14) achieved a clinically meaningful improvement of ≥4 points on the Modified Fatigue Impact Scale (MFIS).
  • Figure 1 analysis revealed only a single disability progression event in the foralumab cohort versus multiple events in the placebo or tolebrutinib arms of the reference trial.
  • Results are not statistically significant due to the small sample size and represent a trend analysis only.
  • Dr. Howard L. Weiner highlighted the encouraging tolerability, disability stabilization, & fatigue improvement trends supporting foralumab as a novel immunomodulatory therapy.
  • CEO Ivor Elrifi noted the unique mechanism of reducing neuroinflammation & expressed plans to advance the program toward approval.
  • Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally.
  • The company is currently evaluating foralumab in an open-label Expanded Access Program (NCT06802328) & a Phase 2a randomized, double-blind trial (NCT06292923).
  • Tiziana's nasal delivery technology aims to improve efficacy, safety, & tolerability compared to intravenous immunotherapy routes.