BOSTON, Mass., October 16, 2026
Tiziana Life Sciences Ltd. (NASDAQ: TLSA), a clinical-stage biopharmaceutical company developing immunomodulation therapies, announced that the final patient has begun dosing in its Phase 2 randomized, placebo-controlled clinical trial evaluating intranasal foralumab in patients with early or mild Alzheimer’s disease (AD). The milestone completes enrollment and initiates dosing for all participants in the study, which is assessing the safety, tolerability and potential efficacy of foralumab administered alone or alongside approved anti-amyloid therapies. The trial includes treatment combinations with lecanemab (Leqembi®) or donanemab. Tiziana expects to report topline results in the first quarter of 2027. The study is investigating whether immunomodulation could complement existing approaches to Alzheimer’s treatment by addressing persistent neuroinflammation associated with the disease.
Trial Evaluates Neuroinflammation and Cognitive Outcomes
The Phase 2 study is designed to evaluate intranasal foralumab as a monotherapy and in combination with lecanemab or donanemab. Key assessment areas include safety and tolerability, changes in neuroinflammation measured through translocator protein positron emission tomography (TSPO-PET) imaging, cognitive function and fluid biomarkers associated with amyloid and tau pathology. The trial builds on evidence indicating that microglial activation and neuroinflammation can persist in people with Alzheimer’s disease, including patients treated with anti-amyloid therapies. TSPO-PET imaging is being used to assess changes in this inflammatory activity. By examining imaging, cognitive and biomarker outcomes, the study aims to generate evidence on the potential role of foralumab in early or mild Alzheimer’s disease. The company has not yet reported topline results from this trial, and its potential clinical benefit remains under investigation.
Intranasal Foralumab Targets Immune Regulation
Foralumab is a fully human monoclonal antibody targeting CD3, a component of the T-cell receptor complex. According to Tiziana, intranasal administration has been shown to stimulate regulatory T cells, which may help modulate immune responses. The company is investigating whether this approach can reduce activated microglia and address chronic neuroinflammation associated with neurological conditions. Tiziana’s scientific leadership cited previous TSPO-PET findings in multiple sclerosis and experience from an expanded-access program involving patients with moderate Alzheimer’s disease as part of the biological rationale for the current study. These earlier observations provide context for the research but do not establish efficacy in the ongoing placebo-controlled Alzheimer’s trial. The company is also evaluating intranasal foralumab in clinical studies involving non-active secondary progressive multiple sclerosis (na-SPMS) and multiple system atrophy (MSA), expanding its investigation of immunomodulation across neuroinflammatory and neurodegenerative diseases.
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Tiziana Advances Its Immunotherapy Development Program
Tiziana said the final patient’s dosing initiation represents an important milestone for the company, clinical sites and participating patients. Chief Executive Officer Ivor Elrifi said the company looks forward to generating data that could help establish immunomodulation as a complementary approach in early Alzheimer’s disease. Dr. Howard L. 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, highlighted the trial’s investigation of whether intranasal foralumab can help regulate activated microglia and potentially influence disease progression. Tiziana describes foralumab as the only fully human anti-CD3 monoclonal antibody currently in clinical development. Its intranasal delivery strategy is intended to provide an alternative to intravenous administration, with the potential to affect efficacy, safety and tolerability. The company’s approach remains investigational, and the anticipated Phase 2 data will be important in evaluating its potential role in Alzheimer’s disease.
Source:::Tiziana Life Sciences,press release
