Tiziana Life Sciences Ltd has announced promising results from its Phase 2a INFORM-MS trial of intranasal foralumab, aimed at treating non-active secondary progressive multiple sclerosis (na-SPMS). This trial's outcomes are noteworthy as they indicate a significant advancement in the company's efforts to develop therapies for a condition that currently lacks FDA-approved disease-modifying treatments. The positive topline results highlight the potential of intranasal foralumab to provide meaningful benefits for patients suffering from this debilitating disease.

The company will host a conference call and webcast with key opinion leaders on November 9, 2026, to discuss these results in detail. The trial demonstrated a statistically significant reduction in neuroinflammation, as measured by TSPO PET imaging, and improvements in fatigue, a common symptom associated with MS. These findings are particularly significant given the short treatment duration of only 12 weeks.

Background

Tiziana Life Sciences Ltd, incorporated in the British Virgin Islands, operates in the pharmaceutical preparations sector (SIC 2834). The company is listed on the Nasdaq under the ticker TLSA. Tiziana focuses on developing innovative immunomodulatory therapies, with intranasal foralumab being its lead candidate. Recent filings indicate the company is actively engaged in clinical trials and regulatory processes to advance its drug development initiatives.

What the Filing Says

The filing states, "In this multi-center, randomized, double-blind, placebo-controlled Phase 2a trial, the 50µg dose of nasal foralumab delivered a clear and statistically significant immunomodulatory effect, producing a meaningful reduction in neuroinflammation as measured by TSPO PET imaging." The results exceeded established thresholds for clinical relevance and showed greater improvements than placebo.

Impact

The positive results from the INFORM-MS trial may significantly impact patients with na-SPMS, who currently have limited treatment options. The findings also provide a competitive edge for Tiziana Life Sciences in the pharmaceutical preparations industry, where advancements in MS therapies are highly sought after. The trial's success could position Tiziana favorably against other companies developing similar treatments.

What's Next

Tiziana Life Sciences plans to complete the full analysis of the INFORM-MS data set and present detailed results at an upcoming scientific congress. The company also intends to engage with the U.S. Food and Drug Administration regarding next steps in the clinical development of intranasal foralumab.