Tiziana Life Sciences’ Phase 2 Trial Of Nasal Foralumab Accepted Into The Healey ALS MyMatch Program

Tiziana Life Sciences, Ltd., a biotechnology company focused on developing innovative immunomodulation therapies, announced that its Phase 2 clinical trial of intranasal foralumab for 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 is supported by a grant from the ALS Association and will be led by Principal Investigators Dr. Suma Babu and Dr. James Berry at Mass General Brigham. The trial will begin enrollment across multiple rapid-enrolling clinical centers in the United States that are part of the Network of Excellence for ALS (NEALS) Consortium. Treatments that show promise within the Healey ALS MyMatch Program may advance into future regimens of the HEALEY ALS Platform Trial, a large, ongoing late-phase study evaluating multiple ALS therapies, or may move directly into standalone Phase 3 development.

ALS is a severe neurodegenerative disorder that progressively damages motor neurons, resulting in muscle weakness, impaired mobility, and eventual paralysis. Increasing evidence points to neuroinflammation, immune system imbalance, T-cell dysfunction, and microglial activation as important contributors to disease progression. Research to date indicates that intranasal foralumab, a fully human anti-CD3 monoclonal antibody, activates regulatory T cells in the cervical lymph nodes. These cells are believed to travel to the central nervous system, where they help reduce harmful inflammation and restore normal microglial function.

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, noted that the rapid advancement of the study reflects both the urgency within the ALS community and the strong scientific basis supporting nasal foralumab. He explained that the company aims to develop a non-invasive therapy capable of delivering meaningful clinical benefits by harnessing the immune-modulating effects of the nasal route. He also expressed appreciation for the support provided by the ALS Association and the NEALS Consortium, adding that foralumab’s ability to expand regulatory T cells and reduce inflammation in the central nervous system represents a promising approach for slowing disease progression in a genetically defined ALS population.

Tiziana Life Sciences, Ltd., a biotechnology company focused on developing innovative immunomodulation therapies, announced that its Phase 2 clinical trial of intranasal foralumab for 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 is supported by a grant from the ALS Association and will be led by Principal Investigators Dr. Suma Babu and Dr. James Berry at Mass General Brigham. The trial will begin enrollment across multiple rapid-enrolling clinical centers in the United States that are part of the Network of Excellence for ALS (NEALS) Consortium. Treatments that show promise within the Healey ALS MyMatch Program may advance into future regimens of the HEALEY ALS Platform Trial, a large, ongoing late-phase study evaluating multiple ALS therapies, or may move directly into standalone Phase 3 development.

ALS is a severe neurodegenerative disorder that progressively damages motor neurons, resulting in muscle weakness, impaired mobility, and eventual paralysis. Increasing evidence points to neuroinflammation, immune system imbalance, T-cell dysfunction, and microglial activation as important contributors to disease progression. Research to date indicates that intranasal foralumab, a fully human anti-CD3 monoclonal antibody, activates regulatory T cells in the cervical lymph nodes. These cells are believed to travel to the central nervous system, where they help reduce harmful inflammation and restore normal microglial function.

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, noted that the rapid advancement of the study reflects both the urgency within the ALS community and the strong scientific basis supporting nasal foralumab. He explained that the company aims to develop a non-invasive therapy capable of delivering meaningful clinical benefits by harnessing the immune-modulating effects of the nasal route. He also expressed appreciation for the support provided by the ALS Association and the NEALS Consortium, adding that foralumab’s ability to expand regulatory T cells and reduce inflammation in the central nervous system represents a promising approach for slowing disease progression in a genetically defined ALS population.

Dr. Suma Babu, Principal Investigator of the ALS MyMatch Program and Co-Director of the Neurological Clinical Research Institute at Mass General Brigham, said that this multi-site, randomized, placebo-controlled study will combine nasal immunology with advanced assessments of blood, spinal fluid, cellular markers, and cutting-edge brain imaging to better understand the therapy’s effects. Tiziana Life Sciences also confirmed that the ALS Association has awarded a competitive grant to help fund the study following a thorough peer-review process.

Dr. Suma Babu, Principal Investigator of the ALS MyMatch Program and Co-Director of the Neurological Clinical Research Institute at Mass General Brigham, said that this multi-site, randomized, placebo-controlled study will combine nasal immunology with advanced assessments of blood, spinal fluid, cellular markers, and cutting-edge brain imaging to better understand the therapy’s effects. Tiziana Life Sciences also confirmed that the ALS Association has awarded a competitive grant to help fund the study following a thorough peer-review process.