Full Press Release Details
Life Sciences to Dose First Patient in Phase 2 Alzheimer's Trial
MA, December 12, 2025 - 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, announces that enrolment has begun
in its Phase 2 randomized, placebo-controlled early Alzheimer's clinical trial and plans to dose the first patient next week.
Phase 2 clinical trial will evaluate intranasal foralumab both as monotherapy and in combination with an FDA approved anti-amyloid therapy,
lecanemab or donanemab, in patients with early Alzheimer's disease (AD). Baseline clinical assessments, cognitive testing, TSPO-PET
imaging, and fluid biomarkers have been completed in the first participants screened in the trial.
clinical trial launch is supported by new TSPO-PET imaging evidence demonstrating persistent and widespread microglial activation in
an Alzheimer's patient despite treatment with lecanemab, confirming that neuroinflammation remains present even after amyloid plaque
reduction. Lecanemab, marketed by Eisai and Biogen as Leqembi , is one of the two FDA-approved anti-amyloid therapies for treating
early Alzheimer's and is proven to reduce beta-amyloid plaques.
1. TSPO-PET scan of an Alzheimer's patient treated with lecanemab demonstrating persistent and widespread microglial activation
throughout the brain.
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, a founding member of Mass General Brigham, stated, "This PET finding is a critical insight:
clearing amyloid does not turn off the brain's inflammatory response. We believe intranasal foralumab directly addresses this residual
neuroinflammation by inducing regulatory T cells to migrate to the brain and calm activated microglia - a mechanism we have already
shown reduces microglial activation in secondary progressive multiple sclerosis."
2. TSPO-PET scans from intranasal foralumab-treated MS patients showing marked reduction in microglial activation over a 6-month
2 Trial Design and Rationale
study will evaluate whether intranasal foralumab:
enrolment now underway and baseline neuroimaging and biomarkers secured, we are on the verge of testing a fundamentally new approach
to Alzheimer's - one that treats the chronic brain inflammation that is associated with ongoing neurodegeneration. We expect
the first patients to begin dosing within days," said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. "This
milestone marks an important step toward testing whether immune modulation alone, or in combination with amyloid removal, can achieve
disease modification. The PET evidence of inflammation in AD with or without anti-amyloid treatment provides a clear biological rationale
for this innovative strategy."
foralumab is a fully human anti-CD3 monoclonal antibody designed to induce Tregs and suppress pathological neuroinflammation, positioning
it as a potential first-in-class therapy to address the inflammatory component of Alzheimer's disease that remains active even
after amyloid clearance.
Phase 2 study is designed to evaluate the safety, tolerability, and efficacy of intranasal foralumab as both a monotherapy and in combination
with lecanemab or donanemab in early/mild AD. Key endpoints will include measures of neuroinflammation (via TSPO-PET imaging), cognitive
function, and biomarker changes related to amyloid and tau pathology. Results from this trial will inform future development and may
establish a new paradigm for treating AD by targeting neuroinflammation alone or in combination with anti-amyloid therapy.
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).
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
| 1 | https://www.pnas.org/doi/10.1073/pnas.2220272120 |
| 2 | https://www.pnas.org/doi/10.1073/pnas.2309221120 |
Tiziana Life Sciences
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.
more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.
statements made in this announcement are 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 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, 2024, and other periodic reports
filed with the Securities and Exchange Commission. 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.
Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com