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Foralumab (TZLS-401), being researched by Tiziana Life Sciences) is a fully human monoclonal antibody that binds to CD3 epsilon of the T cell receptor-CD3 complex. It is currently being studied in a randomized, double-blind placebo-controlled, multicenter dose-ranging study in a nasal formulation in patients with non-active secondary progressive multiple sclerosis (SPMS).

Clinical research

Nasal administration

Phase 1

Nasal foralumab was studied at the Brigham and Women's Hospital, at the Ann Romney Center. Twenty-seven (9 per group) healthy volunteers received either nasal foralumab (10ug, 50ug, or 250ug daily for 5 days) or they received nasal placebo. Nasal foralumab induced CD8+ Regulatory T cells and reduced CD4+ Suppressor T Cells. Foralumab induced LAP, TIGIT, and KLRG1 immune checkpoint molecules. The treatment was well tolerated by all subjects. The researchers concluded that the Immune effects of nasal foralumab were optimal at the 50ug dose.

Phase 2 - Non-active secondary progressive - Multiple sclerosis

Nasal foralumab is currently being studied in the United States in a randomized, double-blind placebo-controlled, multicenter dose-ranging study in a nasal formulation in patients with non-active secondary progressive multiple sclerosis (SPMS). The two primary outcome measures are 1) To determine the safety and tolerability of 50 μg/dose and 100 μg/dose of foralumab nasal compared to placebo and 2) To investigate the effect of foralumab relative to placebo on the change from baseline PBR06-positron emission tomography (PET) scans for microglial activation, after 12 weeks (3) months of study treatment.

Phase 2 - Non-active secondary progressive - Alzheimer's disease

Dr. Howard Weiner announced that nasal foralumab has been cleared by the FDA to be studied in a 6 month phase 2 trial to assess safety, cognition and reduction in microglia PET imaging.

Phase 2 - COVID-19

Nasal foralumab was studied in 39 patients with mild to moderate COVID-19. They were randomized into 1) Control {standard of care plus a placebo}, 2) 100 μg/dose of nasal foralumab and 3) 100 μg/dose of nasal foralumab plus dexamethasone. Both nasal foralumab alone and nasal foralumab combined with dexamethasone demonstrated more rapid clearance of lung infiltrates as measured by chest CT compared to the control group.

Intravenous administration

Phase 1 - Crohn's disease

Intravenous foralumab was studied in 39 patients with confirmed active Crohn's disease of at least 6 months duration. The patients were given intravenous infusion daily for 5 days. This limited study did not show efficacy.

References

1. ^ Tiziana Life Sciences LTD (2024-03-15). A Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients (Report). clinicaltrials.gov.
2. World Health Organization (2010). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 103" (PDF). WHO Drug Information.
3. Weiner H (August 16, 2023). "Received FDA approval to treat Alzheimer's disease with nasal anti-CD3 (foralumab) in a 6 month phase 2 trial".
4. Moreira TG, Matos KT, De Paula GS, Santana TM, Da Mata RG, Pansera FC, et al. (2021). "Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study". Frontiers in Immunology. 12: 709861. doi:10.3389/fimmu.2021.709861. PMC 8406802. PMID 34475873.
5. van der Woude CJ, Stokkers P, van Bodegraven AA, Van Assche G, Hebzda Z, Paradowski L, et al. (October 2010). "Phase I, double-blind, randomized, placebo-controlled, dose-escalation study of NI-0401 (a fully human anti-CD3 monoclonal antibody) in patients with moderate to severe active Crohn's disease". Inflammatory Bowel Diseases. 16 (10): 1708–1716. doi:10.1002/ibd.21252. PMID 20848453.
6. Giuffrida P, Di Sabatino A (September 2020). "Targeting T cells in inflammatory bowel disease". Pharmacological Research. 159: 105040. doi:10.1016/j.phrs.2020.105040. PMID 32585338. S2CID 220073839.

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