Tiziana Life Sciences Completes Patient Visits in MS Trial

Biotechnology firm Tiziana Life Sciences has concluded the patient participation phase of its Phase 2a INFORM-MS clinical trial, which assesses intranasal foralumab for treating secondary progressive multiple sclerosis (SPMS). The final patient has completed their last scheduled visit.

The randomized, double-blind, placebo-controlled trial enrolled 48 patients across three cohorts. It evaluated the safety, tolerability, and efficacy of intranasal foralumab compared to a placebo over a 12-week treatment period. The primary endpoint focused on changes in microglial activation measured by PET imaging, with secondary endpoints including disability status and fatigue scales.

Tiziana Life Sciences anticipates locking its database this week and plans to release topline data in October. Following the blinded phase, all participants have the option to receive intranasal foralumab in an open-label extension study to gather longer-term safety and efficacy data.

Foralumab is a fully human anti-CD3 monoclonal antibody designed for intranasal administration, aiming to stimulate regulatory T cells. The company is developing it as an immunomodulatory therapy. Previous data from an expanded access program in SPMS patients suggested disease stabilization or improvement in most participants.