Tiziana Life Sciences has initiated dosing at Johns Hopkins University, the third site in its Phase 2 trial of intranasal foralumab for non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The trial aims to evaluate the safety, tolerability, and efficacy of intranasal foralumab in na-SPMS patients, a form of MS marked by progressive neurological decline without relapses. This expansion builds upon existing trial sites at Brigham and Women’s Hospital and Yale Medical Center.
This development is particularly crucial for na-SPMS patients who currently have limited treatment options. The inclusion of a prominent institution like Johns Hopkins underscores the growing interest and potential of foralumab as a novel therapeutic approach. It provides further validation of the drug’s development and could accelerate patient recruitment, leading to more robust data and faster clinical progress.
The Phase 2 trial is a randomized, double-blind, placebo-controlled study. Tiziana anticipates completing the blinded portion by the end of 2025, followed by a six-month open-label extension period for all participants. This open-label extension will provide valuable long-term data on the treatment’s effectiveness and safety. Foralumab, a fully human anti-CD3 monoclonal antibody, is designed to stimulate T regulatory cells when administered intranasally, potentially mitigating neuroinflammation, a key driver of na-SPMS progression. Prior data from an Expanded Access Program with foralumab in na-SPMS patients showed either improvement or disease stability within six months in all participants.
The advancement of this Phase 2 trial with the addition of Johns Hopkins strengthens foralumab’s potential to become a meaningful treatment option for na-SPMS. Positive results could lead to further clinical development and ultimately offer a much-needed new therapy for this debilitating condition. The expansion also enhances Tiziana’s position in the MS therapeutic landscape.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
