1. Tiziana reports no serious adverse events for intranasal foralumab after 37.4 years. 2. FDA denial of Sanofi's drug highlights need for safer neuroinflammatory therapies. 3. Foralumab shows potential in treating naSPMS and Alzheimer's Disease with no new risks. 4. Company's unique nasal delivery method improves tolerability compared to IV therapies. 5. Phase 2 naSPMS trial results expected to release in 2026, heightening interest.
FAQ
Why Bullish?
The strong safety profile of foralumab enhances TLSA's competitive edge. Historically, drug safety reports positively influence biotech stock prices, as seen with successful therapy candidates.
How important is it?
With emerging data showing effective treatment and a favorable safety profile, investor confidence can surge, impacting stock value. The FDA's role in validating drug safety often results in increased stock performance.
Why Short Term?
Anticipation of Phase 2 trial results in 2026 could lead to immediate stock movements. Recent FDA developments may also catalyze quicker market reactions.
Tiziana Life Sciences Submits Annual Safety Report for Intranasal Foralumab to FDA
BOSTON, Dec. 29, 2025 (GLOBE NEWSWIRE) — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA), a biotechnology company focused on innovative therapies, has submitted its seventh annual Development Safety Update Report (DSUR) for intranasal foralumab to the U.S. Food and Drug Administration (FDA). This report reflects the cumulative experience from 37.4 patient-years of use and confirms an excellent safety profile, with no drug-related serious adverse events noted during the reporting period from September 21, 2024, to September 2, 2025.
Significance of Safety Profile in Neuroinflammatory Disease Treatment
The DSUR highlights the safety and tolerability of intranasal foralumab in treating neuroinflammatory conditions like non-active secondary progressive multiple sclerosis (naSPMS), multiple system atrophy, and Alzheimer’s Disease (AD). Tiziana's CEO, Ivor Elrifi, emphasized the importance of these findings in light of the FDA's recent rejection of Sanofi’s tolebrutinib for nrSPMS due to safety concerns. “This underscores the pressing need for safer therapeutic options in the treatment of neuroinflammatory disorders,” stated Elrifi.
Key Highlights from the Development Safety Update Report
- Expanded Access Program: Fourteen patients with naSPMS received intranasal foralumab (50 micrograms per dose) over durations ranging from 23 weeks to 3.5 years, contributing 30.7 patient-years of exposure.
- TILS-021 Randomized Trial and TILS-022 Open-Label Extension: Patients in these studies received doses of either 50 or 100 micrograms, accounting for approximately 5.2 patient-years of exposure.
- Single-Patient Expanded Access for AD: One patient received 28 weeks of treatment, adding 0.5 patient-years.
Robust Clinical Data and Future Directions
The cumulative exposure data of 37.4 patient-years indicates significant clinical experience with intranasal foralumab in central nervous system (CNS) indications. Notably, the adverse events reported were consistent with previous studies, and no new risks were identified that warranted changes to protocols. This favorable safety profile aligns with earlier findings from intravenous (IV) administration studies, showcasing intranasal delivery as a more tolerable method.
About Foralumab and Its Unique Position
Foralumab is a fully human anti-CD3 monoclonal antibody designed to stimulate T regulatory cells via intranasal delivery. As the only fully human anti-CD3 mAb in clinical development, foralumab represents a promising therapeutic avenue for neuroinflammatory and neurodegenerative diseases, with ongoing studies, including a Phase 2a trial in naSPMS (NCT06292923).
About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company pioneering innovative therapies through advanced drug delivery technologies. The company’s approach not only aims to improve the efficacy of treatments but also enhances safety and tolerability compared to traditional IV delivery methods. With numerous patents and pending applications, Tiziana is well-positioned for broad future applications within its therapeutic pipeline.
Forward-Looking Statements
Certain statements in this announcement are forward-looking and reflect Tiziana's expectations regarding future performance. Factors such as market conditions may lead to results differing significantly from those expressed or implied. Tiziana encourages stakeholders to review its risks and uncertainties as detailed in the annual report on Form 20-F filed with the SEC.
Contact Information
For more information about Tiziana and its therapies, please visit www.tizianalifesciences.com. For inquiries, contact:
Paul Spencer
Business Development and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com