Tiziana Life Sciences (US:TLSA) Globenewswire·2025-11-25 13:30Core Viewpoint - Tiziana Life Sciences has announced the acceptance of its Phase 2 clinical trial for intranasal foralumab in ALS patients into the ALS MyMatch Program, indicating a significant step in the development of innovative therapies for this neurodegenerative disease [1][2]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing breakthrough therapies using novel drug delivery technologies, particularly through non-invasive routes like intranasal administration [10]. - The company's lead candidate, foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, showing a favorable safety profile and clinical response in previous studies [10][9]. Clinical Trial Details - The Phase 2 trial will be led by Principal Investigators at Mass General Brigham and will enroll patients at multiple rapid-enrolling U.S. centers within the NEALS Consortium [2]. - The trial aims to evaluate the effects of intranasal foralumab on ALS, leveraging its potential to stimulate regulatory T cells and reduce neuroinflammation [3][4]. Scientific Rationale - ALS is characterized by progressive motor neuron loss, and neuroinflammation is recognized as a key driver of disease progression [3]. - Foralumab is designed to stimulate regulatory T cells in cervical lymph nodes, which may help suppress pathogenic inflammation in the central nervous system [3]. Funding and Collaboration - The study is supported by a grant from the ALS Association, highlighting the collaborative effort to advance ALS research [2][4]. - The ALS MyMatch initiative involves multiple high-enrolling research centers and aims to expedite patient recruitment for clinical trials [5]. Future Implications - Successful outcomes from the trial may lead to further development within the HEALEY ALS Platform Trial or transition to standalone Phase 3 trials, indicating a pathway for potential new treatments for ALS [2].