Tiziana Announces Positive Topline Results from Phase 2a INFORM-MS Trial of Intranasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis
Key Highlights
- ➤50 μg nasal foralumab significantly reduced microglial activation versus placebo (p=0.0168)
- ➤MFIS fell significantly from baseline: -6.17 points at 50 μg, -7.18 at 100 μg
- ➤All 48 participants completed treatment; no deaths, discontinuations, or study-drug-related serious adverse events
- ➤100 μg nasal foralumab produced no statistically significant PET improvement
- ➤Tiziana plans FDA discussions on further development after completing full data analysis
Expert Statements
Tanuja Chitnis, Principal Investigator of the INFORM-MS trial and Professor of Neurology at Harvard Medical School / Brigham and Women’s Hospital
“These results represent a significant milestone for patients with non-active secondary progressive MS, a population with significant unmet need and limited treatment options. The primary imaging endpoint on TSPO PET in the 50 ug nasal foralumab treatment arm from the INFORM-MS study closely mirrors the reductions in microglial activation we previously published in our expanded access program, providing important corroboration in a controlled setting. Equally encouraging is the clinically significant improvement in fatigue as measured by MFIS, despite the short 12-week treatment duration. This clinical effect was notable. We consider these findings as encouraging evidence of the biological activity of nasal foralumab in this MS population where at present there are no approved treatments for these patients. Safety and tolerability were favorable across both doses.”
Tarun Singhal, Founding Director, NeuroPET Program, Ann Romney Center for Neurologic Diseases, Brigham and Women’s Hospital, Mass General Brigham and Associate Professor of Neurology at Harvard Medical School
“These positive topline results from INFORM-MS further validate the therapeutic potential of intranasal foralumab in non-active secondary progressive MS. Seeing a statistically significant reduction in microglial activation on TSPO PET, together with a clinically significant difference in fatigue in both foralumab doses, is highly encouraging. These findings align with what we have observed in the expanded access setting and reinforce the rationale for advancing this novel approach.”
Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences
“We are extremely pleased that INFORM-MS successfully met its primary endpoints for both safety and reduction in neuroinflammation measured by PET imaging of microglial activation. The statistically significant, and clinically significant improvements from baseline in MFIS at both 50 μg and 100 μg doses further strengthens our conviction in the potential of intranasal foralumab. These data, together with the accumulating real-world evidence from our expanded access program in na-SPMS patients, as well as emerging data from our current trials in AD, ALS, and MSA, positions us well as we advance foralumab to the next stage of development. We would like to express our sincere gratitude to the investigators, clinical site staff, and most importantly the patients and their families who participated in the INFORM-MS trial. Their commitment and partnership made this important study possible, and we deeply appreciate their contributions to advancing potential new treatment options for people living with non-active secondary progressive MS.”
* Trial met its dual primary endpoints for (1) statistically significant reduction (p=0.0168) in microglial activation as measured by TSPO PET imaging in patients treated with 50 ug nasal foralumab as compared to placebo and (2) safety/tolerability.
* Foralumab-treated subjects showed statistically significant and clinically significant improvements in Modified Fatigue Impact Scale (MFIS) scores compared with their own baseline scores after only 12 weeks of drug therapy. Subjects treated with 50 ug nasal foralumab saw a -6.17 point decrease from baseline (p=0.035), and those treated with 100 ug experienced a -7.18 decrease from baseline (p=0.040). No significant change was seen in the placebo group. BOSTON, Nov. 02, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody, today announced positive topline data in its Phase 2a INFORM-MS trial with intranasal foralumab (a human, anti-CD3 monoclonal antibody) in patients with non-active secondary progressive multiple sclerosis (na-SPMS).
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