Tiziana Life Sciences Ltd (NASDAQ:TLSA), said it is seeking Fast Track Designation approval from the US Food and Drug Administration (FDA) for its intranasal foralumab therapy to treat non-active, secondary-progressive multiple sclerosis (na-SPMS).
Foralumab, a fully human anti-CD3 monoclonal antibody, has demonstrated the ability to induce T regulatory cell production when administered intranasally.
In an Intermediate-Sized Patient Population Expanded Access (ISPPEA) Program, ten na-SPMS patients receiving foralumab showcased a significant reduction in fatigue scores (MFIS) in 70% of cases, with disease stability observed in all participants within six months.
Currently, intranasal foralumab is undergoing evaluation in a Phase 2a, double-blind randomized, placebo-controlled, multicenter trial for na-SPMS patients.
Gabriele Cerrone, Chairman, acting CEO, and founder of Tiziana Life Sciences, told investors that fast track is designed to speed up the review of drugs in development to treat serious conditions for which there are few therapies available.
“The progressive nature of na-SPMS and lack of FDA-approved therapies for this disease aligns with the Food and Drug Administration’s criteria for Fast Track Designation,” Cerrone said in a statement.
“The increased interaction and partnership with the FDA afforded by this designation would be a tremendous asset to our foralumab development program, if granted.”
Fast Track Designation, if approved, could expedite the regulatory review process for foralumab by facilitating more frequent discussions with the FDA regarding the drug's development plan and clinical trial design. It also opens the possibility of Accelerated Approval and Priority Review, provided relevant criteria are met.