Tiziana Life Sciences (NASDAQ: TLSA) has announced that the first patient has been dosed with intranasal foralumab in its Phase 2 randomized, placebo-controlled clinical trial in patients with early Alzheimer’s disease (AD).
The Phase 2 trial evaluates intranasal foralumab both as monotherapy and in combination with FDA-approved anti-amyloid therapies, lecanemab (Leqembi) or donanemab, in patients with early AD.
In a statement, Gabriele Cerrone, chairman and founder of Tiziana commented, “Dosing the first patient marks a pivotal moment in exploring a novel immunomodulatory approach to AD. Our prior TSPO-PET data in multiple sclerosis patients showed that intranasal foralumab can significantly reduce microglial activation, and we are eager to evaluate its potential impact—alone or combined with anti-amyloid treatments—in slowing disease progression in early AD.”
Ivor Elrifi, CEO of Tiziana, remarked, “We are thrilled to have rapidly advanced from enrolment to first patient dosing in this important Phase 2 trial. This achievement reflects the dedication of our team and clinical sites, as well as the urgent need for new treatment strategies that go beyond amyloid clearance to target chronic neuroinflammation. We look forward to continuing enrolment and generating data that could redefine disease modification in AD.”
