Tiziana Doses Last Patient in Phase 2 Trial of Intranasal Foralumab for Mild Alzheimer’s Disease

Topline data are anticipated in Q1 2027 from testing foralumab alone and alongside approved anti-amyloid therapies.

Rhea-AI Summary

Tiziana Life Sciences (TLSA) has begun dosing the last patient in its Phase 2 trial of intranasal foralumab for early/mild Alzheimer’s disease. Enrollment is complete, and all participants have started dosing; this milestone does not mark completion of treatment. The company anticipates announcing topline data in Q1 2027.

The randomized, placebo-controlled study evaluates foralumab alone and in combination with the FDA-approved anti-amyloid therapies lecanemab or donanemab. It assesses safety, tolerability and potential efficacy. Outcomes include changes in brain inflammation measured through TSPO-PET imaging, a scan used to assess activation of brain immune cells, alongside cognitive function and fluid biomarkers related to amyloid and tau pathology. The study tests an approach targeting inflammation both alone and alongside anti-amyloid treatment.

2 points · 0 major

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointPhase 2 enrollment is complete, with all participants having begun dosing in the early/mild Alzheimer’s trial.
• Minor point. Forward-looking: it has not happened yet and may not happen.Topline data are anticipated in Q1 2027, providing the company’s stated timeline for the trial readout.

Negative

• None.

Key Figures

Topline data timing: Q1 2027

Topline data timing

Q1 2027

Anticipated for the Phase 2 Alzheimer’s trial

Key Terms

monoclonal antibody, placebo-controlled, tsPo-pet imaging, microglial activation

4 terms

monoclonal antibody medical

"a fully human, anti-CD3 monoclonal antibody"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

placebo-controlled medical

"Phase 2 randomized, placebo-controlled clinical trial"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

tsPo-pet imaging medical

"as measured by TSPO-PET imaging"

TSPO-PET imaging is positron emission tomography that uses radioactive tracers binding to the 18 kDa translocator protein (TSPO) to visualize and quantify TSPO expression in tissues, most commonly to image microglial and other glial activation in the brain as a marker of neuroinflammation. The method works by injecting a TSPO-selective radioligand that accumulates where TSPO is upregulated and measuring its regional radioactivity over time; quantification typically requires kinetic modeling or validated reference approaches. A key limitation is that TSPO signal is not specific to a single cell type or to the precise molecular cause of uptake, and common genetic polymorphisms in the TSPO gene alter tracer binding affinity so studies must account for binding-status differences when interpreting results.

microglial activation medical

"persistent neuroinflammation (microglial activation)"

Microglial activation is when the brain’s resident immune cells — microglia — switch from a resting, maintenance role into an alert, defensive state, similar to a neighborhood cleanup crew suddenly racing to douse a small fire. For investors, this matters because persistent or excessive activation is a hallmark of many neurological diseases, affects how drugs perform in trials, and can drive regulatory and market reactions to therapies aimed at calming or harnessing this response.

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BOSTON, Oct. 16, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that the last patient has begun dosing in its Phase 2 randomized, placebo-controlled clinical trial evaluating intranasal foralumab in patients with early/mild Alzheimer’s disease (AD). Topline data are anticipated to be announced in Q1 2027.

This milestone completes enrollment and initiates dosing for all participants in the study, which is assessing the safety, tolerability, and potential efficacy of intranasal foralumab both as monotherapy and in combination with FDA-approved anti-amyloid therapies lecanemab (Leqembi®) or donanemab. The trial builds on evidence of persistent neuroinflammation (microglial activation) in Alzheimer’s patients, including those treated with anti-amyloid agents, as measured by TSPO-PET imaging. Key endpoints include changes in neuroinflammation via TSPO-PET imaging, cognitive function, and fluid biomarkers related to amyloid and tau pathology.

“Dosing the last patient in this important Phase 2 trial is a significant achievement for our team, clinical sites, and the patients participating in the study,” commented Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. “We look forward to generating data that could help establish immunomodulation as a complementary pillar in the treatment of early Alzheimer’s disease.”

“Completing dosing initiation for the final patient marks an important step in testing whether inducing regulatory T cells with intranasal foralumab can calm activated microglia and potentially slow disease progression in mild Alzheimer’s,” commented 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. “Our prior work, including TSPO-PET findings in multiple sclerosis and the moderate Alzheimer’s expanded-access experience, supports the biological rationale that addressing chronic brain inflammation alone or alongside anti-amyloid therapy, may offer meaningful benefit. We look forward to seeing the results from this placebo-controlled trial.”

About the Phase 2 Alzheimer’s Disease Trial
The Phase 2 study is a randomized, placebo-controlled trial in patients with early/mild Alzheimer’s disease. It evaluates intranasal foralumab as monotherapy and in combination with lecanemab or donanemab. Primary focus areas include safety/tolerability, reduction in microglial activation measured by TSPO-PET, cognitive outcomes, and changes in amyloid and tau biomarkers.

About Foralumab
Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923), as well as additional Phase 2 trials in AD and MSA.

Intranasal foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.^[1],[2]

About Tiziana Life Sciences

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative intranasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.

Forward-Looking Statements

Statements in this press release may be “forward-looking statements” within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These forward-looking statements reflect the current beliefs and expectations of Tiziana’s management and include statements regarding the closing of the Offering. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Tiziana’s Annual Report on Form 20-F for the year ended December 31, 2025, and other periodic reports filed with the SEC from time to time. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

For further inquiries:

Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com

[1] https://www.pnas.org/doi/10.1073/pnas.2220272120

[2] https://www.pnas.org/doi/10.1073/pnas.2309221120

FAQ

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What milestone has Tiziana reached in its Phase 2 Alzheimer’s trial?

Tiziana has completed enrollment and begun dosing all participants in its randomized, placebo-controlled trial of intranasal foralumab for early/mild Alzheimer’s disease. The last patient has started treatment; the milestone is dosing initiation, not completion of treatment.

When does Tiziana expect results from its Phase 2 Alzheimer’s trial?

Tiziana anticipates announcing topline data in Q1 2027. The trial evaluates safety, tolerability and potential efficacy of intranasal foralumab alone and in combination with lecanemab or donanemab.