Tiziana Advances ALS Research With IND Filing For Phase 2 Trial Of Intranasal Foralumab

Tiziana Life Sciences, Ltd, a biotechnology company specializing in immunomodulation therapies, has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical trial in Amyotrophic Lateral Sclerosis (ALS). The trial will evaluate the company’s lead candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody, as a potential treatment for ALS. The IND submission is followed by a prestigious grant awarded to Tiziana through the Hoffman ALS Clinical Trial Awards Program by the ALS Association.

Ivor Elrifi, CEO of Tiziana Life Sciences, stated, “We are excited to initiate this important clinical study with the support of the ALS Association grant. This filing represents a significant achievement for our team and underscores our commitment to addressing the urgent medical needs of ALS patients.”

The company’s intranasal foralumab program is now targeting three major neurodegenerative diseases: ALS, Multiple Sclerosis, and Alzheimer’s disease. This grant facilitates collaboration between industry and academia, enabling scientific discoveries in clinical studies to advance treatment options for these conditions.

ALS, otherwise known as Lou Gehrig’s disease, results in fatal neurodegeneration that causes progressive muscle weakness, which advances to paralysis before causing breathing failure, although patients generally survive for around five years following diagnosis. The ongoing work by Tiziana stands as an essential achievement for treating this essential medical requirement. The company will start a clinical trial with 20 patients to study intranasal foralumab at two different dose levels under FDA approval of its IND application for the purpose of assessing safety and potential early signs of disease improvement in order to provide better outcomes for worldwide ALS patients.