Tiziana Life Sciences Completed Multiple Sclerosis Trial

The firm finished patient visits for a Phase 2a trial testing intranasal foralumab in patients with non-active secondary progressive MS.

Updated on Sept. 21, 2026 in Alzheimer’s

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Tiziana Life Sciences finished patient visits for its Phase 2a clinical trial of intranasal foralumab in patients with secondary progressive multiple sclerosis. AI Illustration. Upload story photo >

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Tiziana Life Sciences has completed all patient visits for its INFORM-MS Phase 2a clinical trial. The study assessed the efficacy and safety of intranasal foralumab in 48 patients diagnosed with non-active secondary progressive multiple sclerosis.

Why it matters

This trial investigates if a fully human anti-CD3 monoclonal antibody can modulate immune responses in patients with limited treatment options. The study results will determine if further clinical development of this intranasal approach is viable.

The INFORM-MS trial enrolled 48 participants who were treated for 12 weeks. Researchers utilized positron emission tomography to measure changes in microglial activation alongside standardized disability and fatigue scales.

The players

Tiziana Life Sciences

This biotechnology company focuses on the development of novel therapies for autoimmune and inflammatory diseases.

The details

The randomized, double-blind, placebo-controlled trial tested two different doses of intranasal foralumab against a placebo. Participants who completed the study are now eligible to enroll in a six-month open-label extension to continue receiving the treatment.

Timeline

  1. September 21, 2026: Tiziana announced the completion of the final patient visit.

  2. This week: The company expects to lock the trial database.

  3. October 2026: Tiziana expects to announce the 12-week topline data.

The Big Picture

This study follows a pattern set by the development of anti-CD3 monoclonal antibodies for autoimmune conditions by testing a new delivery mechanism for an existing therapeutic class. This trial marks a shift toward localized nasal delivery to potentially reduce systemic exposure in patients with progressive neurological disorders.

Patients with secondary progressive multiple sclerosis may see new treatment options emerge if the study proves the safety and efficacy of the nasal drug delivery method. The trial results will influence whether future patients gain access to this specific immunotherapy approach.

The takeaway

The successful completion of this trial phase allows for the analysis of novel immune-modulating treatments for neurodegenerative conditions. Stakeholders should monitor the upcoming data release in October to evaluate the potential of intranasal delivery in future clinical protocols.

What happens next

Tiziana Life Sciences is expected to lock its trial database this week, followed by the anticipated release of 12-week topline study data in October 2026.

Further reading

For more information on the latest research in the field, explore the Alzheimer’s section of our site.

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Do you trust that pharmaceutical companies prioritize patient outcomes during the drug development process?