Foralumab - (INFORM-MS)

November 2, 2026: Tiziana Life Sciences (Nasdaq: TLSA) reported positive topline Phase 2a INFORM-MS data for intranasal foralumab in non-active secondary progressive multiple sclerosis (na-SPMS). The randomized, double-blind, placebo-controlled trial met dual primary endpoints: 50 µg foralumab significantly reduced microglial activation on [18F]PBR06 TSPO PET versus placebo after 12 weeks (adjusted treatment difference -0.0231; 95% CI -0.0416 to -0.0046; p=0.0168), and both 50 µg and 100 µg doses were safe and well tolerated.

All 48 participants completed treatment; there were no deaths, no discontinuations due to adverse events, and no study-drug-related serious adverse events. TEAEs occurred in 83.3% of placebo patients and 76.7% of foralumab-treated patients; common events included headache, fall, nasal congestion, and rhinorrhea.

On secondary measures, MFIS fatigue scores improved by -6.17 in the 50 µg arm (p=0.035 vs baseline) and -7.18 in the 100 µg arm (p=0.040) versus -3.12 for placebo; no EDSS change was seen over 3 months. The 100 µg arm did not show a statistically significant PET effect. Next steps are full data analysis, presentation at a scientific congress, and FDA discussions on further development in na-SPMS.