Tiziana completes Phase 2 enrolment for foralumab in Alzheimer's
Tiziana Life Sciences has dosed the final patient in its Phase 2 randomised, placebo-controlled trial of intranasal foralumab in early and mild Alzheimer's disease, marking the completion of enrolment across all participating sites. The NASDAQ-listed company said it expects to report topline data in the first quarter of 2027.
Foralumab is a fully human anti-CD3 monoclonal antibody administered via an intranasal route. When delivered this way, the compound is reported to stimulate regulatory T cells, which Tiziana believes may suppress the chronic microglial activation thought to drive neuroinflammation in Alzheimer's patients. The trial evaluates foralumab both as a monotherapy and in combination with two FDA-approved anti-amyloid agents, lecanemab and donanemab, giving the study a design that could speak to combination strategies as well as immunomodulation as a standalone approach.
Primary endpoints include changes in microglial activation measured by TSPO-PET imaging, cognitive function assessments, and fluid biomarkers covering amyloid and tau pathology.
Scientific rationale
Dr Howard Weiner, chairman of Tiziana's Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women's Hospital, said prior work using TSPO-PET in multiple sclerosis and an expanded-access programme in moderate Alzheimer's patients supports the biological case for targeting brain inflammation. "Addressing chronic brain inflammation alone or alongside anti-amyloid therapy may offer meaningful benefit," he said.
Chief executive Ivor Elrifi described completion of enrolment as a significant achievement for the clinical team and said the company aimed to establish immunomodulation as "a complementary pillar" in early Alzheimer's treatment. The expanded-access programme Weiner referenced has dosed 14 patients with non-active secondary progressive multiple sclerosis, with the company reporting improvement or stability in all patients at six months, though open-label data of this kind carry well-understood limitations.
Market context
The Alzheimer's treatment landscape has shifted materially since the approvals of lecanemab and donanemab, both of which target amyloid plaques but leave neuroinflammation largely unaddressed. A number of companies and academic groups are now pursuing anti-inflammatory or immunomodulatory approaches as adjuncts or alternatives to anti-amyloid strategies, reflecting broader recognition that amyloid clearance alone may not halt cognitive decline in all patients.
Tiziana's intranasal delivery angle also positions the asset differently from intravenous immunomodulatory agents, potentially offering a tolerability and convenience advantage if the clinical data hold up. The company holds patents on its intranasal immunotherapy platform and is also running a Phase 2a trial of foralumab in non-active secondary progressive multiple sclerosis, suggesting a pipeline build-out beyond Alzheimer's.
Investors will be focused on the TSPO-PET readout in particular: if foralumab demonstrably reduces microglial activation in a placebo-controlled setting, that would provide an objective neuroimaging anchor for any efficacy claims, making the Q1 2027 data release a meaningful catalyst for the stock.