Tiziana Life Sciences, Ltd., a biotech company focused on developing innovative immunomodulation therapies through unique drug delivery methods, has received approval from the U.S. Food and Drug Administration (FDA) to expand its intranasal foralumab Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) Expanded Access (EA) Program from 10 to 30 patients.

Among the initial 10 patients enrolled, two have undergone treatment for over a year, and eight others for six months, all experiencing no severe side effects. Notably, all patients have either stabilized or shown improvement while on foralumab, with no decline in key clinical metrics. Additionally, 70% of participants have reported measurable reductions in fatigue. These findings mark a significant advancement, combining PET imaging with a novel ligand, immune-biomarkers, clinical assessments, and comprehensive safety data endpoints for long-term intranasal foralumab use.

Tiziana initiated a Phase 2a trial for na-SPMS in November 2023. Patients who are ineligible for this trial can now be considered for the expanded EA program. The FDA's September 2023 guidance on "Substantial and Confirmatory Evidence of Efficacy and Safety" underscores the significance of EA programs in gathering confirmatory evidence for investigational drugs.

Gabriele Cerrone, Chairman and founder of Tiziana Life Sciences, expressed satisfaction in providing open-label treatment with foralumab to na-SPMS patients who don't qualify for the Phase 2 trial. Given the absence of FDA-approved treatments for na-SPMS, the EA program offers these patients access to a promising therapeutic option.

Dr. Tanuja Chitnis, Professor of Neurology at Harvard Medical School, and senior neurologist at Brigham and Women’s Hospital, welcomed the opportunity to dose an additional 20 patients not meeting Phase 2 trial criteria. She emphasized the invaluable insights gained from the EA program, including dosing information and patient feedback, crucial for designing the ongoing Phase 2a trial.

Foralumab, a fully human anti-CD3 monoclonal antibody, acts on activated T cells, attenuating inflammation by modulating T cell function. This mechanism has shown promise in patients with COVID-19, multiple sclerosis, and healthy subjects. The intranasal foralumab Phase 2 trial for na-SPMS, commenced screening in November 2023, represents a pioneering approach in immunomodulation for neuroinflammatory and neurodegenerative diseases.

 

Source: globenewswire.com

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