- Cough, Mucus, and Respiratory Health: A Complete Guide - August 18, 2025
- Flogoprofen: what it's used for and how to take it - June 21, 2025
- What is Movicol oral solution in sachet used for and how to take it? - June 18, 2025
Tiziana Life Sciences has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical trial that will evaluate the impact of intranasal foralumab, a fully human anti-CD3 monoclonal antibody, in patients with amyotrophic lateral sclerosis (ALS).
This action marks a crucial step towards offering a new treatment option for this fatal neurodegenerative disease, supported by the ALS Association.
Academic support and collaboration
The IND application follows the award of a grant from the ALS Association, part of its Hoffman ALS Clinical Trials Award Program. This grant not only validates the potential of foralumab as a treatment, but also strengthens the collaboration between industry and academia. Tiziana’s approach with this drug encompasses not only ALS, but also other neurodegenerative diseases such as multiple sclerosis and Alzheimer’s.
Ivor Elrifi, CEO of Tiziana Life Sciences, expressed his enthusiasm about this. “This achievement underscores our commitment to address the urgent needs of ALS patients,” he commented. In addition, the company plans to initiate the clinical trial with 20 patients of different doses of foralumab, to evaluate both safety and disease improvement in the early stages of ALS.
Foralumab: A promising candidate in immunological therapies
Foralumab is a fully human anti-CD3 monoclonal antibody that has demonstrated efficacy in modulating regulatory T cells. These cells play a key role in inflammation, making foralumab a promising treatment for inflammatory and neurodegenerative diseases. In previous trials, disease improvement has been observed in patients with non-active secondary progressive multiple sclerosis. In addition, the FDA has recently allowed the enrollment of more patients in its expanded access program, expanding the research possibilities.
Intranasal administration of foralumab represents an innovative way to treat neuroinflammatory diseases. This treatment could change the medical landscape for diseases such as ALS, offering new hope to patients who currently face few effective therapeutic options.
