FDA Accepts Tiziana Life Sciences Fast Track for Multiple Sclerosis Treatment

On June 11, 2024, Tiziana Life Sciences, Ltd. (Nasdaq: TLSA), a biotechnology company focused on innovative immunomodulation therapies, announced the acceptance of its submission for intranasal foralumab to receive Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of non-active, secondary-progressive multiple sclerosis (na-SPMS).

Foralumab is a fully human anti-CD3 monoclonal antibody designed to induce T regulatory (Treg) cells when administered intranasally. Currently, ten patients with na-SPMS have received intranasal foralumab as part of an Intermediate-Sized Patient Population Expanded Access (ISPPEA) Program. The results have shown a significant reduction in fatigue scores for 70% of these patients and disease stability over six months for all participants. In addition, a Phase 2a, double-blind, randomized, placebo-controlled, multicenter trial (NCT06292923) is ongoing to further evaluate intranasal foralumab in na-SPMS patients. The Fast Track Designation request includes data derived from both animal models and clinical experience from the ISPPEA program. If approved, foralumab would become the only intranasal monoclonal antibody treatment for multiple sclerosis, as existing therapies are administered intravenously or subcutaneously.

Fast Track Designation, if granted, underscores the seriousness of na-SPMS and the significant unmet medical need, given the absence of approved therapies for this condition. Gabriele Cerrone, Chairman, acting CEO, and founder of Tiziana Life Sciences, emphasized the importance of Fast Track Designation, stating that it aims to accelerate the review of drugs addressing serious conditions with few or no therapeutic options. He highlighted that na-SPMS meets the FDA’s criteria for this designation due to its progressive nature and the lack of FDA-approved treatments. Cerrone added that the increased interaction and collaboration with the FDA would greatly benefit the development of foralumab.

A drug receiving Fast Track Designation is eligible for several advantages, including more frequent meetings with the FDA to discuss the development plan and ensure the collection of necessary data for drug approval. Additionally, there is more regular written communication from the FDA regarding the design of proposed clinical trials and the use of biomarkers.

Activated T cells are crucial in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody, binds to the T cell receptor and reduces inflammation by modulating T cell function, thereby suppressing the effector functions in multiple immune cell subsets. This effect has been demonstrated in patients with COVID-19 and multiple sclerosis, as well as in healthy subjects. The Phase 2 trial for intranasal foralumab in non-active SPMS (NCT06292923) began patient screening in November 2023. The use of nasal anti-CD3 monoclonal antibodies represents a novel approach to treating neuroinflammatory and neurodegenerative diseases.

Tiziana Life Sciences is a clinical-stage biopharmaceutical company that focuses on developing breakthrough therapies using transformational drug delivery technologies, enabling alternative routes of immunotherapy. The company’s innovative nasal delivery approach offers the potential for improved efficacy, safety, and tolerability compared to intravenous delivery. Tiziana’s lead candidate, intranasal foralumab, has shown a favorable safety profile and clinical response in studies to date. The company’s technology for alternative immunotherapy routes has been patented, with several applications pending, and is expected to allow for broad pipeline applications.