Tiziana Life Sciences announced that it has submitted an IND to the FDA seeking approval for a Phase 2 trial of intranasal foralumab in patients with amyotrophic lateral sclerosis. In November 2024, the company announced that it had received a grant from the ALS Association to fund a trial in patients with ALS. According to the company, the planned Phase 2 study would evaluate two dose levels of intranasal foralumab in 20 ALS patients.
Intranasal foralumab is already in Phase 2 development for the treatment of secondary progressive multiple sclerosis (SPMS) and is in early development for the treatment of Alzheimer’s disease. The company also recently announced data from a preclinical study of nasal foralumab in combination with semaglutide in a mouse model of obesity.
Tiziana CEO Ivor Elrifi commented, “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.”
Read the Tiziana Life Sciences press release
