Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that its Phase 2 clinical trial evaluating intranasal foralumab in patients with amyotrophic lateral sclerosis (ALS) has been accepted into the ALS MyMatch Program at the Sean M Healey & AMG Center for ALS at Mass General Brigham.
The study, supported by a grant from the ALS Association, will be led by Principal Investigators Suma Babu and James Berry at Mass General Brigham. It will enroll participants at multiple rapid-enrolling US sites within the Network of Excellence for ALS (NEALS) Consortium.
Investigational products showing positive results in the Healey ALS MyMatch program may advance to the HEALEY ALS Platform Trial or proceed directly to standalone Phase 3 trials.
ALS is a neurodegenerative disease marked by progressive motor neuron loss, leading to muscle weakness and paralysis. Emerging research highlights neuroinflammation and immune dysregulation as key factors in disease progression.
Tiziana’s investigational therapy, nasally administered foralumab, a fully human anti-CD3 monoclonal antibody, is designed to stimulate regulatory T cells in cervical lymph nodes, which then migrate to the central nervous system to suppress inflammation and support microglial function.
“The rapid progression to trial activation reflects the urgency of the ALS community and the compelling science behind nasal foralumab,” Tiziana CEO Ivor Elrifi said in a statement.
Elrifi said that by using the nasal route to modulate the immune system, the goal is to provide meaningful clinical benefits through a non-invasive therapy.
“Foralumab’s ability to expand regulatory T cells and dampen CNS inflammation offers a biologically rational approach to slowing progression in a genetically defined ALS population. We are eager to translate these mechanisms into patient benefit,” Elrifi said.
Principal Investigator Babu added: “This innovative multi-site randomized placebo-controlled trial will integrate innovative nasal immunology with cutting-edge blood, spinal fluid and cellular and advanced brain imaging markers to understand the effect of the drug."
Investors cheered the update, sending Tiziana’s shares 6.4% higher before Tuesday’s opening bell.