Tiziana Life Sciences Advances Alzheimer’s Program, Doses First Patient In Phase 2 Study

Tiziana Life Sciences, Ltd., a biotechnology company focused on developing innovative immunomodulatory therapies, has announced that the first patient has been dosed with intranasal foralumab in its Phase 2 randomized, placebo-controlled clinical trial for early Alzheimer’s disease (AD). Intranasal foralumab is a fully human anti-CD3 monoclonal antibody and serves as the Company’s lead development candidate. 

This dosing milestone follows the announcement on December 12, 2025, that trial enrollment had begun and the first patient dosing was imminent. The study is designed to evaluate intranasal foralumab both as a standalone therapy and in combination with FDA-approved anti-amyloid therapies, lecanemab (Leqembi®) or donanemab, in patients with early-stage AD.

The Phase 2 trial is informed by TSPO-PET imaging data showing persistent and widespread microglial activation—a key marker of neuroinflammation—in Alzheimer’s patients, even after amyloid plaque reduction with lecanemab. This highlights the unmet need for therapies that target residual neuroinflammation, which intranasal foralumab aims to address by modulating immune responses and calming overactive microglia.

Gabriele Cerrone, Chairman and Founder of Tiziana Life Sciences, stated that dosing the first patient represents a pivotal step in testing a novel immunomodulatory approach for Alzheimer’s disease. He noted that prior TSPO-PET data in multiple sclerosis patients demonstrated that intranasal foralumab can significantly reduce microglial activation, and the Phase 2 trial will assess whether similar effects can help slow disease progression in early AD, both alone and in combination with anti-amyloid treatments.

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented that moving from enrollment to first patient dosing so quickly reflects the commitment of the Company’s team and clinical sites. He emphasized the urgent need for new treatment strategies that go beyond amyloid clearance to address chronic neuroinflammation. The Company plans to continue enrolling patients and generating data that could help redefine approaches to disease modification in Alzheimer’s disease.