Tiziana's intranasal foralumab cuts microglial activation in MS at lower dose, but higher dose fails
- In the Phase 2a INFORM-MS study in non-active secondary progressive MS, the 50 µg dose (19 patients) met both dual primary endpoints, including a significant reduction in microglial activation versus placebo at 12 weeks by PET imaging.
- The 100 µg dose (11 patients) missed the efficacy endpoint, showing no significant difference from placebo.
- Both doses were described as safe and well tolerated; common adverse events were headache, fall, nasal congestion and runny nose.
- Tiziana plans to present detailed data at a scientific meeting and to meet the FDA about a possible path forward.
💡 Points Based on public reports
One dose hit, the higher dose missed, and that is the whole story: a non-monotonic response in 30 patients with no effect sizes or p-values is a hint, not proof. PET microglial activation is a biomarker, not disability. Before any FDA meeting means much, I want clinical outcomes and a plausible reason the 100µg arm failed.
Tiziana touts multiple sclerosis win at lower dose as high dose misses mark ↗