University of Massachusetts Begins Phase 2 MS Trial with Intranasal Foralumab

Tiziana Life Sciences, Ltd., a biotechnology firm based in New York and listed on Nasdaq as TLSA, has announced the advancement of its ongoing Phase 2 trial of intranasal foralumab in treating non-active secondary progressive multiple sclerosis (na-SPMS). Recently, the trial marked a new milestone with the University of Massachusetts (UMass) joining the study as its fourth clinical site. This adds to the collaboration with Brigham and Women’s Hospital, Yale Multiple Sclerosis Center, and Johns Hopkins University Autoimmunity Center of Excellence. The trial is anticipated to conclude by the end of 2025.

The trial is double-blinded and placebo-controlled, intent on evaluating the efficacy of foralumab in patients with na-SPMS. Upon completion of the blinded phase of the trial, all participants, including those initially receiving a placebo, will be eligible for a six-month open-label extension. This phase aims to observe the long-term safety and effectiveness of foralumab.

William A. Clementi, PharmD, Chief Development Officer at Tiziana, expressed enthusiasm about UMass joining the trial, which is seen as a testament to the growing interest within the scientific community. The study emphasizes the potential of intranasal foralumab to become a pivotal treatment for patients with non-active SPMS, a currently underserved group. The intranasal administration of the drug also allows patients to take it at home, potentially improving treatment adherence and outcomes when compared to intravenous alternatives that demand clinical visits.

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, noted the expansion of the trial with UMass as a significant progression towards making foralumab available to na-SPMS patients. He credited the dedication of the researchers, investigators, and participating patients for the trial's advancements and eagerly anticipates the insights the study will yield regarding foralumab's potential benefits.

Foralumab stands out as the first fully human anti-CD3 monoclonal antibody delivered intranasally. This innovative administration method aims to activate regulatory T cells, fostering immune tolerance while reducing systemic immune suppression. This non-systemic method represents a novel approach in treating neuroinflammatory and neurodegenerative diseases.

The development of foralumab involved prior dosing in a different study, where 10 na-SPMS patients showed either disease stability or improvement over six months. This was conducted under an Expanded Access Program. Currently, intranasal foralumab is under evaluation in a Phase 2a randomized, double-blind, placebo-controlled, multicenter, and dose-ranging trial specifically targeting na-SPMS patients.

Tiziana Life Sciences is a clinical-stage biopharmaceutical company focusing on breakthrough therapies utilizing transformative drug delivery methods to provide alternative immunotherapy routes. Its innovative intranasal technique promises to enhance efficacy and safety compared to traditional intravenous approaches. The company has patented various technologies for alternative immunotherapy delivery, which are expected to support a wide range of pipeline applications. Tiziana is committed to its mission of developing and delivering innovative treatments to improve patient care.