Tiziana Life Sciences to dose first patient in Phase 2 Alzheimer’s trial

Tiziana Life Sciences (TLSA) announces that enrolment has begun in its Phase 2 randomized, placebo-controlled early Alzheimer’s clinical trial and plans to dose the first patient next week. “The Phase 2 clinical trial will evaluate intranasal foralumab both as monotherapy and in combination with an FDA approved anti-amyloid therapy, lecanemab or donanemab, in patients with early Alzheimer’s disease. Baseline clinical assessments, cognitive testing, TSPO-PET imaging, and fluid biomarkers have been completed in the first participants screened in the trial,” the company stated. “With enrolment now underway and baseline neuroimaging and biomarkers secured, we are on the verge of testing a fundamentally new approach to Alzheimer’s – one that treats the chronic brain inflammation that is associated with ongoing neurodegeneration. We expect the first patients to begin dosing within days. This milestone marks an important step toward testing whether immune modulation alone, or in combination with amyloid removal, can achieve disease modification. The PET evidence of inflammation in AD with or without anti-amyloid treatment provides a clear biological rationale for this innovative strategy,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences.