The FDA has granted Fast Track designation to Tiziana Life Sciences’ intranasal foralumab, an anti-CD3 monoclonal antibody, for the treatment of non-active secondary progressive multiple sclerosis (na-SPMS), the company said. Tiziana is also developing intranasal foralumab for the treatment of Alzheimer’s disease and has announced plans to develop the nasal formulation of the mAb for the treatment of diabetes, hemorrhagic stroke, ALS, and long COVID.
In December 2023, Tiziana announced the initiation of a Phase 2a trial of intranasal foralumab in patients with non-active secondary progressive multiple sclerosis, and that trial is underway. In addition, the company notes that 10 patients with na-SPMS have been treated under an expanded access program, and the FDA will allow 20 more patients to be treated under that program.
Tiziana Chairman and acting CEO Gabriele Cerrone commented, “We are thrilled to receive Fast Track designation from the FDA for intranasal foralumab for the treatment of multiple sclerosis. This designation underscores the potential of foralumab to address critical unmet needs in the treatment of neurodegenerative diseases. We are committed to advancing this promising therapy as quickly as possible to benefit patients.”
Chief Development Officer William Clementi said, “Receiving Fast Track designation is a testament to the innovative approach we are taking with foralumab. We believe that the intranasal delivery method offers a novel way to effectively target neuroinflammation, and we look forward to working closely with the FDA to bring this therapy to patients in need.”
Read the Tiziana Life Sciences press release.
