Neurology-Focused Tiziana Life Confirms Discovery In Multiple Sclerosis Therapy Study

On Wednesday, Tiziana Life Sciences, Ltd. TLSA announced the discovery of new immune biomarkers in patients with non-active secondary progressive multiple sclerosis (na-SPMS) treated with nasal foralumab.

The company says the findings contribute substantially to understanding the immune mechanisms underlying the effects of nasal foralumab.

The study identified gene expression changes detected three months after intranasal dosing of foralumab in the ongoing ISPPEA (or expanded access program). Key findings include modulation of:

• FoxP3 T regulatory cells (Tregs)
• CD4+ and CD8+ central memory T cells
• CD14+ and CD14- monocytes
• Naïve B cells

These pathways are associated with antigen presentation, interferon responses, and other regulatory immune mechanisms.

In this study, single-cell RNA sequencing of peripheral blood samples taken before and at three and six months after drug administration has revealed relevant gene expression changes associated with nasal foralumab, which has been associated with a reduction in microglial brain inflammation, as measured by advanced microglial PET scans in these same patients.

The FDA defines a biomarker as a characteristic measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.

In December, Tiziana dosed the first patient with moderate Alzheimer’s disease using intranasal foralumab and announced the expansion of its Phase 2 trial evaluating intranasal foralumab for non-active secondary progressive multiple sclerosis.

Earlier this month, Tiziana announced findings on the prolonged benefits of its nasal anti-CD3 monoclonal antibody in sustaining tissue homeostasis and mitigating the side effects associated with discontinuing GLP-1 agonists.

Price Action: TLSA stock is up 6.56% at $0.85 during the premarket session at last check Thursday.

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