Tiziana Life Sciences Ltd has announced encouraging results from its Phase 2a INFORM-MS trial, which tested its intranasal foralumab in patients with non-active secondary progressive multiple sclerosis (na-SPMS). The trial successfully met its primary endpoints, demonstrating a statistically significant reduction in neuroinflammation and improvements in patient-reported fatigue levels. This development could mark a significant advancement in treatment options for a condition currently lacking FDA-approved therapies.

On November 2, 2026, Tiziana Life Sciences Ltd (Nasdaq: TLSA) filed a report detailing the positive outcomes from its INFORM-MS trial. The trial results are particularly noteworthy as they indicate that intranasal foralumab, a fully human anti-CD3 monoclonal antibody, can effectively reduce microglial activation and improve fatigue in patients suffering from na-SPMS.

Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery methods. The company’s lead candidate, intranasal foralumab, aims to address significant unmet medical needs in the treatment of neurological diseases. The recent filing, accession number 0001213900-26-114650, highlights the company’s commitment to advancing its research and development efforts.

The INFORM-MS trial was a randomized, double-blind, placebo-controlled study involving multiple clinical sites in the United States. Patients were treated with either a placebo or doses of intranasal foralumab (50 µg or 100 µg) over a 12-week period. The trial met its dual primary endpoints, showing a statistically significant reduction in neuroinflammation as measured by TSPO PET imaging (p=0.0168) and confirming the safety and tolerability of the treatment.

In addition to the reduction in microglial activation, patients receiving foralumab reported significant improvements in their fatigue levels. The Modified Fatigue Impact Scale (MFIS) scores showed a decrease of -6.17 points for the 50 µg dose and -7.18 points for the 100 µg dose, compared to a -3.12 point change in the placebo group. These findings suggest that intranasal foralumab could provide meaningful relief for patients suffering from fatigue associated with na-SPMS.

The trial results were met with optimism from Tiziana’s leadership. Ivor Elrifi, CEO of Tiziana Life Sciences, expressed satisfaction with the trial's outcomes, stating, “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.” He emphasized the importance of these findings in advancing treatment options for patients with limited alternatives.

The pharmaceutical preparations industry is closely watching Tiziana’s progress, as the positive trial results could influence the development of similar therapies targeting neuroinflammatory conditions. The success of intranasal foralumab may encourage other companies to explore innovative delivery methods and treatment strategies for neurological diseases.

As Tiziana Life Sciences moves forward, the company plans to conduct a full analysis of the INFORM-MS data and present detailed results at an upcoming scientific congress. Additionally, Tiziana intends to engage with the U.S. Food and Drug Administration to discuss the trial outcomes and potential pathways for further clinical development of intranasal foralumab in treating na-SPMS.

This development not only signifies a potential breakthrough for Tiziana but also sets a precedent in the pharmaceutical industry for addressing the challenges of treating progressive forms of multiple sclerosis. With no current FDA-approved therapies for na-SPMS, the implications of these findings could be far-reaching, impacting both patients and the broader landscape of neurological treatment options.

In conclusion, Tiziana Life Sciences Ltd's positive results from the INFORM-MS trial represent a significant milestone in the quest for effective treatments for non-active secondary progressive multiple sclerosis. As the company prepares for the next steps in its development process, the industry will be keenly observing how these advancements unfold.