FDA grants fast track designation for intranasal MS therapeutic

The FDA has granted fast track designation for intranasal administration of a fully human anti-CD3 monoclonal antibody to treat non-active, secondary-progressive multiple sclerosis, according to the manufacturer.

Tiziana Life Sciences said in a press release that foralumab has been shown to cause T regulatory (Treg) cell induction when dosed intranasally.

At present, 10 individuals with non-active, secondary-progressive MS have been dosed in an Intermediate-Sized Patient Population Expanded Access program. Clinically meaningful reduction in fatigue scores were recorded in 70% of participants, and stability of disease was noted within 6 months in all 10 patients, per the release.

Foralumab would be the only intranasal monoclonal antibody designated, as other MS-related monoclonal antibody therapies require IV or subcutaneous dosing, Tiziana said in the release.

Tiziana had previously initiated a phase 2a clinical trial of intranasal foralumab in December 2023.

“Fast track is designed to expedite the review of drugs in development to treat serious conditions for which there are limited or no therapies,” Gabriele Cerrone, chairman, acting CEO and founder of Tiziana Life Sciences, said in the release. “The increased interaction and partnership with the FDA afforded by this designation would be a tremendous asset to our foralumab development program, if granted.”

Tiziana additionally said in the release that intranasal foralumab is currently being studied in a phase 2a, double-blind randomized, placebo-controlled, multicenter trial.