Tiziana Life Sciences Completes Patient Enrollment in MS Clinical Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 21 2026
0mins
Tiziana Life Sciences announces that patient enrollment has been completed in its randomized, double-blind, placebo-controlled Phase 2a clinical trial evaluating intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis. Topline data is expected in late Q3 of 2026, and will also to be presented at the 10th joint Americas Committee for Treatment and Research in Multiple Sclerosis and ECTRIMS meeting in Toronto, Canada in October 2026. The trial, known as INFORM-MS, is the first Phase 2 placebo-controlled study of intranasal foralumab, marking a significant milestone in the clinical development of this novel anti-CD3 monoclonal antibody for neurodegenerative and neuroinflammatory diseases. The multicenter study has enrolled 48 patients across multiple leading U.S. sites to receive one of two doses of intranasal foralumab or placebo over a 12-week treatment period, with assessments including PET imaging for microglial activation, MRI, clinical evaluations, and biomarkers. Following the completion of the blinded phase, all participants including those who initially received placebo will have the opportunity to receive intranasal foralumab during a six-month open label extension phase. The OLE is designed to assess long term safety and sustained benefit of foralumab in the na-SPMS patient population.
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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
- 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.
See More
Tiziana Completes Enrollment in na-SPMS Clinical Trial
- 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.
See More
Tiziana Releases Positive Clinical Data for Foralumab in MS Treatment
- 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.
See More
Tiziana Life Sciences Reports Positive Data on Foralumab for MS
- 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.
See More
Tiziana Updates Clinical Data Showing Safety and Efficacy of Foralumab
- Strong Safety Profile: In the ongoing Expanded Access Program, Tiziana's foralumab demonstrated excellent tolerability in 14 patients with non-active Secondary Progressive Multiple Sclerosis, with no new safety signals identified, indicating its reliability for long-term treatment.
- Disability Stabilization Trend: Data from the Expanded Access Program show a favorable trend in disability stabilization, with a reduction in Confirmed Disability Progression events, suggesting the drug's potential in controlling disease progression and improving patients' quality of life.
- Significant Fatigue Improvement: 64% of patients achieved a clinically meaningful improvement of ≥4 points on the Modified Fatigue Impact Scale (MFIS), reflecting not only the drug's efficacy but also its potential to enhance patients' daily functioning and overall well-being.
- Promising Future Research: Tiziana's CEO noted that foralumab's unique mechanism may offer a new treatment paradigm for progressive forms of multiple sclerosis, with future studies aimed at further validating its clinical application potential and advancing the drug towards approval.
See More
Biotech Sector Regulatory Approvals and Collaborations
- Kidney Cancer Treatment Breakthrough: HUTCHMED and Innovent received NMPA approval in China for the ELUNATE-TYVYT combination therapy, supported by the FRUSICA-2 study showing a 63% reduction in disease progression or death risk, with a median progression-free survival of 22.2 months, significantly improving patient outcomes and enhancing market competitiveness.
- Antibiotic Market Expansion: Sunshine Biopharma received Canadian approval for its generic Amoxicillin, with shipments expected to begin in August 2026, aiming to increase access to high-quality antibiotics for treating common infections, which is anticipated to drive revenue growth for the company.
- Liquid Biopsy Technology Innovation: Guardant Health gained FDA approval for Guardant360 Liquid CDx, now the largest liquid biopsy panel with a genomic footprint 100 times broader than its predecessor, enhancing tumor profiling capabilities and expected to boost the company's market share in precision medicine.
- New Hypertension Drug Launch: AstraZeneca received FDA approval for BAXFENDY for hypertension patients, based on positive results from the BaxHTN Phase III trial, which is expected to strengthen the company's competitive position in the cardiovascular drug market and further expand its product line.
See More
Tiziana Life Sciences Completes Patient Enrollment in Foralumab Trial
- 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.
See More
Tiziana Completes Enrollment in na-SPMS Clinical Trial
- 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.
See More
Tiziana Releases Positive Clinical Data for Foralumab in MS Treatment
- 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.
See More
Tiziana Life Sciences Reports Positive Data on Foralumab for MS
- 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.
See More
Tiziana Updates Clinical Data Showing Safety and Efficacy of Foralumab
- Strong Safety Profile: In the ongoing Expanded Access Program, Tiziana's foralumab demonstrated excellent tolerability in 14 patients with non-active Secondary Progressive Multiple Sclerosis, with no new safety signals identified, indicating its reliability for long-term treatment.
- Disability Stabilization Trend: Data from the Expanded Access Program show a favorable trend in disability stabilization, with a reduction in Confirmed Disability Progression events, suggesting the drug's potential in controlling disease progression and improving patients' quality of life.
- Significant Fatigue Improvement: 64% of patients achieved a clinically meaningful improvement of ≥4 points on the Modified Fatigue Impact Scale (MFIS), reflecting not only the drug's efficacy but also its potential to enhance patients' daily functioning and overall well-being.
- Promising Future Research: Tiziana's CEO noted that foralumab's unique mechanism may offer a new treatment paradigm for progressive forms of multiple sclerosis, with future studies aimed at further validating its clinical application potential and advancing the drug towards approval.
See More
