Full Press Release Details
Sciences Announces Comprehensive Positive Results from Study of Nasal Foralumab in Patients with Multiple Sclerosis
NEW YORK, May 6, 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, today announced promising results
from an open-label clinical study evaluating nasal foralumab, the world's only fully human anti-CD3 monoclonal antibody administered
intranasally, for the treatment of non-active secondary progressive multiple sclerosis (na-SPMS). This comprehensive study demonstrated
that nasal foralumab was safe, induced potent regulatory immune responses, reduced microglial activation, and stabilized clinical progression
in patients suffering from progression independent of relapse activity (PIRA)-a major unmet need in the treatment of MS, and a key
disease endpoint for intranasal foralumab development. The article is titled "Nasal foralumab treatment of PIRA induces regulatory
immunity, dampens microglial activation and stabilizes clinical progression in non-active secondary progressive MS." This study
is the first to integrate, F18TSPO PET, Proteomics, and Clinical assessments in na-SPMS. These findings in MFIS score reduction are a
critically important Quality of Life (QoL) measure for patients with MS.
"Our findings mark a significant advancement for patients living
with non-active Secondary Progressive MS, who currently have very limited treatment options," said Tanuja Chitnis, M.D., Principal
Investigator and Professor of Neurology at Harvard Medical School and senior neurologist at Brigham and Women's Hospital, a founding
member of Mass General Brigham Healthcare System. "Nasal administration of foralumab represents a novel, non-invasive approach that
not only induces regulatory immunity but also reduces harmful CNS inflammation."
PIRA and progressive forms of MS are characterized by central nervous
system-centric inflammation driven by microglial activation, processes not adequately addressed by existing therapies. Traditional MS
treatments targeting B-cells and cell trafficking have limited efficacy in managing progression behind the blood-brain barrier.
Nasal foralumab leverages the mucosal immune system to induce regulatory
immune responses, offering a novel mechanism to suppress CNS inflammation without the systemic immunosuppression seen with intravenous
therapies. Previous studies showed that nasal anti-CD3 could treat progressive MS in animal models by expanding LAP+ and IL-10+ Tregs,
providing the scientific rationale for this human study.
In parallel with these encouraging results, Tiziana Life Sciences has
initiated a randomized, double-blind, placebo-controlled Phase 2 clinical trial to further assess the efficacy and safety of nasal foralumab
in a larger cohort of patients with na-SPMS. This trial is expected to reach top line data read out at the end of 2025.
"We are incredibly excited by these results, which validate the
potential of nasal foralumab to fundamentally shift the treatment paradigm for progressive MS," said Ivor Elrifi, Chief Executive
Officer of Tiziana Life Sciences. "We are also committed to advancing this promising therapy into other larger clinical studies,
such as Alzheimer's Disease and ALS as quickly as possible."
This article has been submitted for peer review, and the full preprint
is available here: https://www.medrxiv.org/content/10.1101/2025.04.30.25326602v1
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, 10 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).
Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb)
currently in clinical development. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November
of 2023. 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 nasal 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
For more information about Tiziana Life Sciences and its innovative
pipeline of therapies, please visit www.tizianalifesciences.com.
Forward-Looking Statements
Certain 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, 2023, 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.
For further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com