Tiziana Life Sciences signs KAIMRC MOU for RRMS combination trial

Tiziana will collaborate with Saudi Arabia's KAIMRC on a clinical trial combining intranasal foralumab with anti-CD20 therapy in poorly responding RRMS patients.

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A bright, modern clinic room features a beige recliner chair, a large window, wooden wall panels, a white wall displaying blue digital heartbeat and data graphics, and a marble counter with illuminated controls.

Tiziana Life Sciences has signed a memorandum of understanding with the King Abdullah International Medical Research Center (KAIMRC) and the Foundation for Neurologic Diseases to pursue a clinical trial in relapsing-remitting multiple sclerosis. The agreement was formalised on 16 September at the Riyadh Global Medical Biotechnology Summit by Tiziana chief executive Ivor Elrifi.

The intended trial would evaluate intranasal foralumab, Tiziana's lead anti-CD3 monoclonal antibody, in combination with an existing anti-CD20 therapy for RRMS patients who are not adequately controlled on anti-CD20 treatment alone. The rationale is that suboptimal response in this population may be driven by residual neuroinflammation that anti-CD20 agents do not adequately suppress, an area where foralumab's mechanism of stimulating T regulatory cells is proposed to be complementary.

A distinct MS programme

Elrifi emphasised that the RRMS collaboration does not alter Tiziana's primary focus on non-active secondary progressive MS. A Phase 2a randomised, double-blind, placebo-controlled trial in na-SPMS is currently blinded, with results anticipated in October 2026. An open-label expanded access programme in na-SPMS has also dosed 14 patients, with the company reporting improvement or disease stability in all participants within six months. Foralumab is additionally being studied in Phase 2 trials in Alzheimer's disease and multiple system atrophy.

Tiziana positions foralumab as the only fully human anti-CD3 monoclonal antibody currently in clinical development. Earlier anti-CD3 antibodies, notably teplizumab, were humanised rather than fully human and were dosed intravenously; teplizumab gained FDA approval in type 1 diabetes in 2022. The intranasal delivery route is central to Tiziana's differentiation argument: the company contends it produces a tolerogenic immune effect with a more favourable safety and tolerability profile than intravenous administration.

Market and regulatory context

The RRMS landscape is intensely competitive. Anti-CD20 therapies from large pharmaceutical companies hold dominant market positions, and the bar for demonstrating meaningful clinical benefit on top of established standard of care is high. Add-on combination studies in MS face particular regulatory scrutiny: regulators typically require robust evidence of additive or synergistic efficacy and will closely examine whether any safety signals compound. The MOU is a non-binding framework, and no clinical trial start date, patient enrolment target, or regulatory submission timeline has been disclosed.

KAIMRC operates under Saudi Arabia's Ministry of National Guard Health Affairs and is aligned with the kingdom's Vision 2030 health strategy, which has been channelling investment into translational research infrastructure. Partnerships with Saudi academic medical centres have become an increasingly common route for clinical-stage Western biotechs seeking to diversify their trial geography and access patient populations in the Gulf region. Whether the collaboration produces a fully enrolled, powered study will depend on trial design agreement, ethics approvals in both jurisdictions, and Tiziana's broader capital position as it awaits the na-SPMS Phase 2 readout.

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