Intranasal Foralumab Receives Fast Track Designation as Potential Tx for Non-Active SPMS

An intranasal formulation for foralumab (Tiziana Life Sciences, New York, NY) has been granted Fast Track Designation by the Food and Drug Administration (FDA) for investigation as a potential treatment for non-active Secondary Progressive Multiple Sclerosis (na-SPMS). Foralumab is a fully human anti-CD3 monoclonal antibody (mAb), which binds to the T-cell receptor and reduces inflammation through T-cell function modulation. In 2023, the FDA cleared the Investigational New Drug application for intranasal foralumab to be studied as a potential treatment for Alzheimer disease (AD).

Intranasal foralumab is currently under investigation in a phase 2a clinical trial (NCT06292923) assessing the medication’s safety, tolerability, and efficacy as a treatment for na-SPMS. The randomized, double-blind, placebo-controlled, multicenter dose-ranging study is assessing 3 primary endpoints: 1) the number of participants reporting adverse events (AEs); 2) changes in Total Nasal Symptom Score (TNSS); and 3) change from baseline in PET scans for microglial activation after 12 weeks of treatment.

Additionally, in an open-label intermediate sized Expanded Access (EA) Program, 10 people with na-SPMS have received treatment with intranasal foralumab. Within 6 months, each of these 10 participants has shown improvement or stability of disease, and the FDA has recently approved the enrollment of an additional 20 participants.

"This designation underscores the potential of foralumab to address critical unmet needs in the treatment of neurodegenerative diseases,” said Gabriele Cerrone, Chairman, acting CEO, and Founder of Tiziana Life Science. “We are committed to advancing this promising therapy as quickly as possible to benefit patients."

Fast Track Designation is intended to expedite development and review of therapies for serious conditions with unmet medical needs. It allows for more frequent FDA communication and, potentially, accelerated approval.