BOSTON, Mass. — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana”), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces that the last patient in its ongoing Phase 2a clinical trial has received their first dose of intranasal foralumab for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS). Topline data is expected in late Q3/early Q4 of 2026, and is planned to be presented at the 10th joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and ECTRIMS meeting in Toronto, Canada in October 2026.
The randomized, double-blind, placebo-controlled Phase 2a trial, known as INFORM-MS (NCT06292923), is evaluating the safety, tolerability, and efficacy of two doses of intranasal foralumab versus placebo in up to 48 patients with na-SPMS. The study includes multiple U.S. investigational sites and focuses on both imaging biomarkers and clinical outcomes.
Final dosing is underway across multiple leading U.S. clinical sites, including Brigham and Women’s Hospital, Johns Hopkins University, Weill Cornell Medicine, Yale MS Center, and others. The primary endpoint of the trial is the change in microglial activation as measured by positron emission tomography (PET) scans, with additional clinical evaluations including the Expanded Disability Status Scale (EDSS), quality of life assessments, and the Modified Fatigue Impact Scale (MFIS).
“Participating as Principal Investigator in the INFORM-MS trial has been incredibly rewarding,” said Tanuja Chitnis, M.D., Principal Investigator and Senior neurologist at the Mass General Brigham Neuroscience Institute. “Intranasal foralumab represents a promising and innovative therapeutic strategy for patients with non-active secondary progressive MS. We are encouraged by the smooth initiation of dosing across sites and look forward to evaluating its impact on microglial activation, and then further clinical outcomes during the open label extension in this underserved patient population.”
“We are thrilled to reach this important milestone in our Phase 2 program,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. “The successful initiation of dosing in all patients underscores the strong execution by our clinical teams and the enthusiasm from investigators and patients for this novel intranasal approach. We are especially grateful for the unwavering contributions of Principal Investigator Dr. Tanuja Chitnis, whose expertise and dedication have been instrumental in advancing this trial.
Intranasal foralumab has the potential to modulate the immune system in a targeted manner with a favorable safety profile, offering new hope for patients with na-SPMS, a condition with limited treatment options.”
Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development delivered intranasally. This innovative route of administration aims to provide improved efficacy, safety, and tolerability compared to traditional intravenous delivery by targeting immune modulation directly in the nasal passages, with potential effects on the central nervous system.
The Company will continue monitoring patients through the 12-week treatment period and open-label extension, with topline data anticipated in the coming months.
About Foralumab
Foralumab, a fully human anti-CD3 monoclonal antibody, is a biologic candidate that has been shown to stimulate T regulatory cells when dosed intranasally. Currently, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).
Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2],[3]
About Tiziana Life Sciences
Tiziana is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
For more information about Tiziana and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.
For further inquiries
Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: [email protected]
References
[1] https://www.pnas.org/doi/10.1073/pnas.2220272120
[2] https://www.pnas.org/doi/10.1073/pnas.2309221120
[3] https://www.neurology.org/doi/10.1212/NXI.0000000000200543