Tiziana Completes Enrollment in Phase 2 MS Trial, Awaits Data
Event summary
- Tiziana fully enrolled its Phase 2a trial (INFORM-MS) for intranasal foralumab in non-active secondary progressive multiple sclerosis (na-SPMS), hitting 48 patients across U.S. sites.
- Topline data expected in late Q3 2026, with results to be presented at the ACTRIMS-ECTRIMS meeting in October 2026.
- Trial includes PET imaging, MRI, and biomarker assessments, with a six-month open-label extension phase for all participants.
- Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development, targeting neuroinflammation via intranasal delivery.
The big picture
Tiziana’s completion of enrollment in the Phase 2a trial for foralumab marks a critical step in validating its intranasal approach for neuroinflammatory diseases. The study’s rigorous design, including placebo control and advanced imaging, could set a new standard for assessing treatments in na-SPMS, a segment with high unmet need. Success here would reinforce the biotech’s pipeline potential and its ability to compete in the crowded MS therapy landscape.
What we're watching
- Clinical Efficacy
- Whether intranasal foralumab demonstrates meaningful efficacy in na-SPMS patients, potentially opening a new treatment paradigm for a condition with limited options.
- Regulatory Pathway
- The pace at which Tiziana can advance foralumab into later-stage trials or seek regulatory approvals, given the novel mechanism and delivery route.
- Market Differentiation
- How Tiziana positions foralumab against existing and emerging therapies for progressive MS, leveraging its intranasal delivery advantage.
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