Tiziana Life Sciences has secured funding from the ALS Association to conduct a clinical trial evaluating the safety and efficacy of intranasal foralumab in patients with amyotrophic lateral sclerosis (ALS). The grant will support an early-stage trial involving 20 ALS patients, where researchers will investigate two different doses of the intranasal antibody therapy. This initiative follows encouraging data from studies in multiple sclerosis (MS), where foralumab demonstrated a significant reduction in neuroinflammation and stabilization or improvement in disability levels.
The upcoming trial aims to determine if foralumab can offer similar benefits in ALS, a progressive neurodegenerative disease with limited treatment options. The ALS Association's Hoffman ALS Clinical Trial Awards Program, which provided the funding, supports early clinical trials focused on gathering safety, dosing, and biomarker data to advance experimental therapies.
"We are honored to receive this prestigious grant from the ALS Association, which underscores the promising potential of our therapeutic platform in addressing the urgent needs of ALS patients," said Ivor Elrifi, CEO of Tiziana, in a company press release.
Foralumab's Mechanism of Action
Inflammation is believed to play a significant role in the onset and progression of ALS, driven by excessive activity of immune T-cells and microglia. Foralumab is an antibody-based therapy designed to modulate T-cell activity by targeting the CD3 protein on their surface. Preclinical studies in animal models have shown that this mechanism can reduce the activity of inflammatory T-cells while simultaneously enhancing the activity of anti-inflammatory T-cells, leading to a reduction in overall inflammation.
Prior Studies in Multiple Sclerosis
Foralumab has been previously tested in 10 patients with nonactive secondary progressive MS, a condition characterized by chronic inflammation in the brain and spinal cord. Data from expanded access programs revealed that all 10 patients treated with foralumab experienced stabilization or improvement in their disability levels after at least six months. Furthermore, PET imaging data indicated reduced microglial activity in the brains of eight of these patients.
A Phase 2b trial (NCT06292923) is currently underway, comparing the safety and efficacy of foralumab to a placebo in patients with nonactive secondary progressive MS. This trial will also utilize PET imaging to assess the drug's effect on markers of brain inflammation, building upon the findings from the expanded access programs.
The planned clinical trial in ALS will incorporate PET scans to measure brain inflammation, with the goal of determining whether foralumab can effectively reduce harmful immune system activity in ALS patients.
"We will be using PET imaging to detect neuroinflammation in this study of patients with ALS. We hope to replicate the previous positive findings of the PET imaging approach that Tiziana has seen in studies of patients with multiple sclerosis, in this new potential indication for intranasal foralumab," stated James Berry, MD, and Suma Babu, director and co-director of the Neurological Clinical Research Institute at Mass General Hospital.
