Tiziana Life Sciences (US) ((TLSA)) announced an update on their ongoing clinical study.
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Study Overview: Tiziana Life Sciences is conducting a Phase 2a study titled A Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients. The study aims to evaluate the safety and effectiveness of nasal foralumab, a human anti-CD3 monoclonal antibody, in treating non-active secondary progressive multiple sclerosis (SPMS). The primary objectives are to assess the safety and tolerability of different doses and to observe changes in PET scans for microglial activation.
Intervention/Treatment: The study tests nasal foralumab, administered in two doses (50 μg and 100 μg), against a placebo. Foralumab is designed to treat autoimmune and inflammatory diseases by modulating immune responses.
Study Design: This interventional study is randomized and uses a parallel assignment model. It employs triple masking, meaning the participant, care provider, and investigator are unaware of the treatment assignments. The primary purpose is treatment-focused, aiming to determine the drug’s efficacy and safety.
Study Timeline: The study began on February 2, 2024, with the last update submitted on October 10, 2025. These dates are crucial as they mark the study’s progression and the latest information available, indicating ongoing recruitment and data collection.
Market Implications: The study’s progress could positively influence Tiziana Life Sciences’ stock by showcasing potential advancements in treating SPMS, a challenging condition. Successful outcomes may boost investor confidence and position the company favorably against competitors in the autoimmune treatment market.
The study is ongoing, with further details available on the ClinicalTrials portal.