Intranasal Foralumab Receives Fast Track Designation for Nonactive Secondary Progressive MS

London-based Tiziana Life Sciences recently received fast track designation from the FDA for intranasal foralumab in the treatment of nonactive secondary progressive multiple sclerosis (SPMS). The company’s lead candidate is a fully human anti-CD3 monoclonal antibody currently in a phase 2a trial for the potential treatment of nonactive SPMS.

Most people living with MS have relapsing remitting MS (RRMS), which is characterized by episodes of new or worsening symptoms (relapse) followed by recovery periods (remittance). Over time, RRMS typically progresses to SPMS. With SPMS, patients experience steadily worsening MS-related symptoms and disability.

SPMS is further described as active or nonactive, with active SPMS referring to periods of relapses or new lesion formation. Nonactive SPMS has been deemed more difficult to treat than active SPMS. Currently, mitoxantrone IV infusion is the only available treatment for this type of MS.

The FDA grants fast-track designation to investigational treatments with the potential to fill unmet medical needs in treating serious conditions. Fast track designation allows pharmaceutical developers to have more frequent meetings with the FDA with the intent of expediting the development and review process for potentially important drugs and treatments.

Foralumab is designed to target the CD3 protein on the surface of immune T-cells, thereby suppressing inflammatory T-cells and boosting regulatory T-cell action. In a previous study, foralumab reduced brain microglial activity in 80% of patients with nonactive SPMS and improved fatigue in 70% of participants.

The ongoing phase 2a trial will enroll 54 adults with nonactive SPMS. The participants will be randomized to receive 50-mg or 100-mg doses of intranasal foralumab or placebo during three-week cycles. During each cycle, participants will receive one half-dose spray into each nostril three times per week for two weeks, followed by a one-week rest period. The FDA previously approved at-home dosing of intranasal foralumab for patients with MS.

The trial’s primary outcomes are treatment safety and microglial activity after 12 weeks of study treatment.