Tiziana Life Sciences Reports Positive Data on Foralumab for MS

Written by Emily J. Thompson, Senior Investment Analyst

Source: seekingalpha

Updated: May 19 2026

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TLSA-0.71%

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Source: seekingalpha

Enhanced Drug Tolerance: Tiziana Life Sciences' study indicates that the intranasal foralumab for multiple sclerosis is well-tolerated in patients, with no new safety signals reported, suggesting sustained safety in clinical applications.
Favorable Disease Stabilization: Among 14 patients with non-active secondary progressive multiple sclerosis, the analysis shows a favorable tendency toward disease stabilization, further supporting foralumab's potential efficacy in treatment.
Significant Fatigue Improvement: The study found that 64% of subjects (9 out of 14) achieved at least a four-point improvement in fatigue levels, as measured by the Modified Fatigue Impact Scale Score, indicating foralumab's positive impact on patients' quality of life.
Future Development Outlook: CEO Ivor Elrifi expressed satisfaction with the continued positive safety and clinical trend data from the Expanded Access Program and looks forward to advancing the program toward approval, demonstrating the company's confidence in future prospects.

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About TLSA

Tiziana Life Sciences Ltd. is a biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Its clinical pipeline includes drug assets for Non-Active Secondary Progressive Multiple Sclerosis, Multiple System Atrophy, Alzheimer’s, and Amyotrophic lateral sclerosis. Its lead immunotherapeutic candidate, Foralumab (TZLS-401), is being developed for Non-Active Secondary Progressive Multiple Sclerosis, Alzheimer’s and other CNS indications. Its Anti-IL-6R mAb (TZLS-501), a fully human mAb, binds to both membrane-bound and soluble forms of IL-6R, an inflammatory cytokine driving chronic inflammation associated with autoimmune and cancer, reducing circulating levels of the IL-6 cytokine. Milciclib is a potent, small molecule inhibitor of multiple cyclin-dependent kinases (CDKs), tropomycinreceptor kinases and Src family kinases controlling cell growth and malignant progression of cancer.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.

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Tiziana Life Sciences Completes Patient Enrollment in Foralumab Trial

May 21 2026stocktwits

Trial Progress: Tiziana Life Sciences has completed patient enrollment of 48 individuals with non-active secondary progressive multiple sclerosis in the U.S., marking a significant milestone for its randomized, double-blind, placebo-controlled Phase 2a clinical trial, with topline data expected in Q3 2026 and results to be presented at a major MS research conference.
Efficacy Assessment Methods: The trial will evaluate efficacy using PET imaging, MRI scans, clinical evaluations, and biomarker analyses, ensuring a comprehensive assessment of the drug's potential, which could advance the application of the anti-CD3 monoclonal antibody in neurodegenerative and neuroinflammatory diseases.
Extension Phase: After the blinded phase, all participants, including those initially assigned to placebo, will be eligible to receive intranasal foralumab in a six-month open-label extension phase to assess long-term safety and whether the benefits are sustained in patients with na-SPMS.
Positive Market Reaction: Following the announcement of patient enrollment completion, Tiziana Life Sciences' shares rose over 9% on Thursday, and retail sentiment on Stocktwits shifted from 'bullish' to 'extremely bullish', indicating strong investor confidence in the company's prospects.

Tiziana Completes Enrollment in na-SPMS Clinical Trial

May 21 2026Newsfilter

Trial Enrollment Completion: Tiziana Life Sciences has announced the completion of patient enrollment in its Phase 2 clinical trial for non-active Secondary Progressive Multiple Sclerosis (na-SPMS), involving 48 patients, marking a significant milestone in the development of its lead anti-CD3 monoclonal antibody, foralumab.
Data Release Expectations: Topline data from the trial is anticipated to be released in late Q3 2026 and will be presented at the ACTRIMS and ECTRIMS meeting in October, providing critical evidence for the drug's market potential and efficacy.
Open Label Extension Phase: Following the blinded phase, all participants will have the opportunity to receive foralumab during a six-month open label extension, designed to assess long-term safety and sustained benefits, thereby enhancing treatment options for patients.
Innovative Delivery Method: As the only fully human anti-CD3 monoclonal antibody, foralumab utilizes an intranasal delivery method that directly targets the brain's immune mechanisms, showcasing its potential in treating neuroinflammatory and neurodegenerative diseases, which could transform existing treatment paradigms.

Tiziana Releases Positive Clinical Data for Foralumab in MS Treatment

May 20 2026NASDAQ.COM

Clinical Data Update: Tiziana Life Sciences updated clinical data from its expanded access program for Foralumab, showing positive progress in treating non-active secondary progressive multiple sclerosis (na-SPMS), with 14 patients treated over 6 months demonstrating significant disability stabilization.
Fatigue Improvement: Results indicate a 64% improvement in fatigue as measured by the Modified Fatigue Impact Scale (MFIS), reflecting not only the drug's efficacy but also its potential to enhance patients' quality of life, which is clinically significant.
Favorable Safety Profile: Foralumab exhibited a favorable safety and tolerability profile, outperforming both placebo and standard-of-care drug tolebrutinib in Expanded Disability Status Scale (EDSS) and MFIS scores, further supporting its clinical application potential.
Future Development Prospects: With FDA breakthrough therapy designation granted in 2024, the ongoing Phase 2a randomized double-blind trial will provide additional data for Foralumab's application in multiple sclerosis treatment, potentially creating significant market opportunities for the company.