Tiziana KOL Call Highlights Consistency Between Positive Phase 2a INFORM-MS Topline Results and Longer-Term Clinical Benefits Observed in Expanded Access Program for Patients with Non-Active Secondary Progressive Multiple Sclerosis Treated with Intranasal Foralumab
Key Highlights
- ➤50 μg dose reduced microglial activation versus placebo, p=0.0168
- ➤MFIS improved significantly after 12 weeks: –6.17 points at 50 μg
- ➤MFIS improved significantly after 12 weeks: –7.18 points at 100 μg
- ➤Expanded access stabilized EDSS scores in all 10 peer-reviewed patients
- ➤14-patient expanded access program shows favorable tolerability up to three years
Expert Statements
Tanuja Chitnis, Principal Investigator of INFORM-MS and Professor of Neurology at Harvard Medical School and Brigham and Women’s Hospital
“The primary imaging endpoint on TSPO PET in the 50 μg 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 placebo-controlled study.”
Tanuja Chitnis, Principal Investigator of INFORM-MS and Professor of Neurology at Harvard Medical School and Brigham and Women’s Hospital
“Equally encouraging is the clinically significant improvement in fatigue as measured by MFIS, despite the short 12-week treatment duration in the Phase 2 trial.”
Tanuja Chitnis, Principal Investigator of INFORM-MS and Professor of Neurology at Harvard Medical School and Brigham and Women’s Hospital
“These findings, together with the complete absence of anti-drug antibodies even with prolonged dosing, the longer-duration clinical stabilization and improvement seen in the expanded access patients, underscore the therapeutic potential of nasal foralumab in a population with no FDA-approved therapies specifically indicated for na-SPMS.”
Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences
“The industry and scientific community interest in our November 9 KOL call underscores the significance of these data.”
Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences
“The consistency between the placebo-controlled 12-week Phase 2a results and the real-world, longer-term experience in our expanded access program strengthens our conviction in intranasal foralumab.”
Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences
“Early biological activity on PET and clinically meaningful fatigue improvements after only three months align with the clinical benefits, including EDSS stabilization and improvement, observed with sustained dosing beyond six and twelve months.”
Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences
“We look forward to completing the full analysis of the INFORM-MS dataset, discussing next steps with the FDA, and advancing this program for patients who currently have limited options.”
BOSTON, Nov. 09, 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 provided additional context on the positive topline results from its Phase 2a INFORM-MS trial, building on the Key Opinion Leader (KOL) investor call held on Monday, November 9, 2026.
The November 9 call, featuring principal investigator, Tanuja Chitnis, M.D., Tarun Singhal, MBBS, M.D., M.B.A., and Howard L. Weiner, M.D., reviewed the dual primary endpoint success of INFORM-MS with the investment and scientific communities.
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