Tiziana Life Sciences Ltd (NASDAQ:TLSA) said on Tuesday it has begun dosing patients at Yale MS Center in its multicenter Phase 2 trial evaluating intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for non-active secondary progressive multiple sclerosis (na-SPMS).
The study, which aims to assess the safety and effectiveness of foralumab in mitigating disease progression, is also enrolling patients at Johns Hopkins, UMass Medical Center, and Brigham and Women’s Hospital, the company said in a statement.
"This trial represents a significant milestone in our clinical development program for intranasal foralumab," said William Clementi, chief development officer at Tiziana Life Sciences.
The double-blinded, placebo-controlled trial is expected to conclude by the end of 2025. Patients initially receiving a placebo will have the option to participate in a six-month open-label extension to further evaluate the long-term safety and durability of foralumab’s effects.
Dr Erin Longbrake, associate professor of neurology at Yale School of Medicine, said the initiation of dosing is an "exciting advancement" in understanding and potentially treating non-active SPMS.
Tiziana is developing foralumab as an immunomodulation therapy targeting autoimmune diseases. The Phase 2 study incorporates brain PET imaging, immunology, and clinical measures recognized by the US Food and Drug Administration.