Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that the last patient has completed their last visit in the Company’s Phase 2a clinical trial evaluating intranasal foralumab 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). Tiziana expects to lock the database this week, and announce 12-week treatment topline data in October.

Following completion of the blinded phase, all participants, including those who initially received placebo, have the opportunity to receive intranasal foralumab in a six-month follow on open-label extension (OLE). The OLE is designed to generate longer term safety and efficacy data. Encouragingly, data from the Company’s Expanded Access Program in na-SPMS have shown that most patients treated with intranasal foralumab either stabilized or improved in clinical outcomes over an extended treatment duration.