Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that the University of Massachusetts has commenced dosing patients in its ongoing Phase 2 trial of its lead candidate intranasal foralumab, a fully human anti CD3 monoclonal antibody, for non-active secondary progressive multiple sclerosis (na-SPMS).
UMass joins Brigham and Women’s Hospital, Yale Multiple Sclerosis Center, and Johns Hopkins University in actively enrolling and treating trial participants.
The trial is a blinded, placebo-controlled study and is expected to conclude by the end of the year.
Upon completion, all participants will be eligible to receive intranasal foralumab in a six-month open-label extension phase, which will evaluate the treatment’s long-term safety and potential sustained benefit.
“The increasing number of premier institutions participating in our study reflects great enthusiasm within the scientific and medical communities for intranasal foralumab as a potential treatment for patients with non-active SPMS,” Tiziana chief development officer William Clementi said.
“We remain committed to advancing this important research as we work toward a much-needed new treatment for this underserved patient population.”
Clementi highlighted that intranasal dosing allows foralumab to be administered at home. “Our hope is that this improves compliance and outcomes versus more commonly seen intravenous dosing which can be a burden on a patient population who suffer with fatigue, and who would normally need to attend a clinic,” he said.
Ivor Elrifi, Tiziana's CEO, added that the initiation of dosing at UMass marked a significant step in the company’s mission to bring foralumab to patients with non-active SPMS.
“We look forward to the completion of the study and the insights it will provide into the potential benefits of foralumab,” Elrifi said.