Tiziana Life Sciences Ltd (NASDAQ:TLSA) has filed an investigational new drug application with the Food and Drug Administration for a clinical trial in Amyotrophic Lateral Sclerosis (ALS).
Tiziana, which is advancing lead candidate intranasal foralumab, said on Tuesday it planned a phase two trial including 20 patients upon clearance.
Submission of the fully human, anti-CD3 monoclonal antibody followed a grant from the ALS Association, the company said.
“We are excited to initiate this important clinical study with the support of the ALS Association grant,” chief executive Ivor Elrifi commented.
“This filing represents a significant achievement for our team and underscores our commitment to addressing the urgent medical needs of ALS patients.”
Tiziana’s intranasal foralumab programs are also focused on Multiple Sclerosis and Alzheimer’s, alongside ALS, which leads to paralysis and is always fatal.
“Despite its devastating impact, treatment options remain limited, highlighting the critical importance of advancing research efforts like those undertaken by Tiziana,” it said.
Two doses of the candidate would be administered in the trial to assess safety and early-stage parameters of disease improvement in ALS patients, Tiziana added.