Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that it has completed patient enrollment in its Phase 2a clinical trial evaluating intranasal foralumab in patients with non-active secondary progressive multiple sclerosis (na-SPMS), marking a key milestone for the company’s lead drug candidate.
The randomized, double-blind, placebo-controlled study, known as INFORM-MS (NCT06292923), is assessing the safety and potential efficacy of intranasal foralumab, a fully human anti-CD3 monoclonal antibody designed to modulate immune activity and reduce neuroinflammation.
The trial enrolled 48 patients across multiple US clinical sites, with participants receiving either one of two doses of intranasal foralumab or placebo over a 12-week treatment period. Assessments include PET imaging for microglial activation, MRI scans, clinical evaluations and biomarker analysis.
Following completion of the blinded portion of the study, all participants, including those initially assigned to placebo, will be eligible to enter a six-month open-label extension phase designed to evaluate long-term safety and durability of response.
The company said topline results from the trial are expected in the late third quarter of 2026. Data will also be presented at the 10th joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Toronto in October 2026.
“This completion of enrollment in our Phase 2a trial represents a pivotal moment for Tiziana Life Sciences and for patients suffering from na-SPMS, a condition with limited treatment options,” Tiziana CEO Ivor Elrifi said in a statement.
“As the first placebo-controlled trial of intranasal foralumab, this study underscores our commitment to rigorously evaluating this innovative therapy’s potential to modulate the immune system and address neuroinflammation.”
Tiziana executive chairman and founder Gabriele Cerrone said reaching full enrollment reflects “strong belief in foralumab’s potential” and the need for new therapies in secondary progressive MS.
“Intranasal delivery offers a novel, non-invasive route that targets the brain’s immune mechanisms directly. This achievement highlights the progress of our pipeline and brings us closer to delivering transformative benefits to patients,” Cerrone said.