BOSTON, November 25, 2025 — Leads & Copy — Tiziana Life Sciences, Ltd. will have its Phase 2 clinical trial of intranasal foralumab in patients with amyotrophic lateral sclerosis (ALS) included in the ALS MyMatch Program.
The Sean M. Healey & AMG Center for ALS at Mass General Brigham accepted the trial into its program. The study is supported by a grant from the ALS Association.
Principal Investigators Suma Babu and James Berry will lead the trial at Mass General Brigham. The trial will enroll at multiple rapid-enrolling U.S. centers within the Network of Excellence for ALS (NEALS) Consortium.
According to the release, successful investigational products from the Healey ALS MyMatch program may advance to future regimens of the HEALEY ALS Platform Trial, or transition directly to standalone Phase 3 trials.
ALS is characterized by progressive motor neuron loss, leading to muscle weakness and paralysis. According to the company, neuroinflammation and immune dysregulation are key drivers of disease progression.
Tiziana Life Sciences is developing breakthrough immunomodulation therapies. Preclinical and clinical evidence indicate that nasally administered foralumab stimulates regulatory T cells in cervical lymph nodes, which then migrate to the central nervous system to suppress pathogenic inflammation and restore microglial homeostasis.
Tiziana Life Sciences CEO Ivor Elrifi said the rapid progression to trial activation reflects the urgency of the ALS community and the science behind nasal foralumab. Elrifi also stated that by leveraging the immune-modulatory potential of the nasal route, the company aims to deliver meaningful clinical impact with a non-invasive therapy.
According to Elrifi, 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.
Suma Babu said this 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.
Tiziana Life Sciences was awarded a competitive grant to fund this study following peer review by the ALS Association.
ALS MyMatch is a multi-site, collaborative initiative that brings together four trial-ready, high enrolling ALS research centers and is a NEALS affiliated program. Research centers include Mass General in Boston; University of Minnesota in Minneapolis, Minn.; Northwestern University in Evanston, Ill.; and Nova Southeastern University in Fort Lauderdale, Fla.
Sean M. Healey & AMG Center for ALS at Mass General Brigham is committed to bringing together scientists, physicians, nurses, foundations, federal agencies, and people living with ALS to accelerate ALS therapy discovery and development.
Foralumab is a fully human anti-CD3 monoclonal antibody, a biological drug candidate that has been shown to stimulate T regulatory cells when administered intranasally. According to the release, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis have been dosed in an open-label intermediate sized Expanded Access Program with either an improvement or stability of disease seen within 6 months in all patients. Intranasal foralumab is also being studied in a Phase 2a trial in patients with non-active secondary progressive multiple sclerosis.
Foralumab is the only fully human anti-CD3 monoclonal antibody currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.
Tiziana Life Sciences is developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. The company’s lead candidate, intranasal foralumab, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
For further inquiries:
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
Source: Tiziana Life Sciences
