Tiziana Life Sciences announced that its Phase 2 intranasal Foralumab trial has been accepted into the Healey ALS MyMatch Program at the Sean M. Healey & AMG Center for ALS at Mass General Brigham. The acceptance places Foralumab on a fast‑track path that could lead to enrollment in the HEALEY ALS Platform Trial or a standalone Phase 3 study, potentially shortening the drug’s development timeline by several years.
The Healey ALS MyMatch Program, launched in 2025, is a biomarker‑driven, patient‑centric early‑phase platform that matches investigational products to ALS patients across multiple rapid‑enrolling sites in the Network of Excellence for ALS (NEALS) Consortium. The program is supported by a grant from the ALS Association, underscoring the partnership’s commitment to advancing ALS therapeutics. By entering this program, Foralumab gains access to a coordinated, multi‑center infrastructure that can accelerate patient recruitment, data collection, and regulatory engagement.
Foralumab is a fully human anti‑CD3 monoclonal antibody delivered intranasally to stimulate regulatory T cells and dampen neuroinflammation. Pre‑clinical studies and early‑phase trials in multiple sclerosis have shown reduced neuroinflammatory markers and stabilized disability, providing a strong scientific rationale for its application in ALS. The intranasal route offers a non‑invasive delivery method that may enhance central nervous system exposure while minimizing systemic exposure.
Chief Executive Officer Ivor Elrifi said, “The rapid progression to trial activation reflects the urgency of the ALS community and the compelling science behind nasal Foralumab. By leveraging the immune‑modulatory potential of the nasal route, we aim to deliver meaningful clinical impact with a non‑invasive therapy. We are deeply grateful to the ALS Association for their partnership and to the NEALS Consortium for their operational excellence.” Principal Investigator Suma Babu added, “This innovative multi‑site randomized placebo‑controlled trial will integrate advanced blood, spinal fluid, cellular, and brain imaging markers to understand the drug’s effect.”
The acceptance positions Tiziana Life Sciences as a key player in the ALS therapeutic landscape, enhancing its visibility within a leading research network and potentially opening pathways to larger, more definitive studies. The milestone also signals to investors and partners that the company’s intranasal delivery platform is progressing beyond early‑phase feasibility, strengthening the case for future funding and collaboration opportunities.
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