Tiziana Completes Key Phase 2a Trial for Multiple Sclerosis Treatment

BOSTON, Sept. 21, 2026 /CourierPR/ -- Tiziana Life Sciences, a biotechnology company developing breakthrough immunomodulation therapies, today announced that the last patient has completed their last visit in the Phase 2a clinical trial of intranasal foralumab, a fully human anti-CD3 monoclonal antibody, in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The randomized, double-blind, placebo-controlled Phase 2a trial, known as INFORM-MS (NCT06292923), enrolled a total of 48 patients across three cohorts at multiple leading U.S. clinical sites. The study is evaluating the safety, tolerability, and efficacy of two doses of intranasal foralumab versus placebo over a 12-week treatment period, with the primary endpoint focused on change in microglial activation as measured by positron emission tomography (PET) imaging, along with secondary clinical endpoints including the Expanded Disability Status Scale (EDSS) and the Modified Fatigue Impact Scale (MFIS).

The last patient to complete the trial is a significant achievement for Tiziana Life Sciences, as it marks a critical milestone in the development of intranasal foralumab for patients living with non-active Secondary Progressive Multiple Sclerosis, a condition with unmet medical need. The trial, which enrolled 48 patients across three cohorts, is the first to evaluate the safety and efficacy of intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis. The study is designed to generate long-term safety and efficacy data, and participants will have the opportunity to receive intranasal foralumab in a six-month follow-on open-label extension (OLE).

Tiziana Life Sciences expects to lock the database this week and announce 12-week treatment topline data in October. The company has also observed encouraging data from its Expanded Access Program in non-active Secondary Progressive Multiple Sclerosis, where most patients treated with intranasal foralumab either stabilized or improved in clinical outcomes over an extended treatment duration.

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, congratulated the entire Tiziana team, clinical investigators, study sites, and most importantly the patients and their families who made this milestone possible.

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 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), as well as additional Phase 2 trials in AD and MSA.

Intranasal 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.

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana's innovative intranasal 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.