RE: Progress12 Dec 2025 21:42
Great news Mog :-)
BOSTON, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, 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 (AD). Baseline clinical assessments, cognitive testing, TSPO-PET imaging, and fluid biomarkers have been completed in the first participants screened in the trial.
The clinical trial launch is supported by new TSPO-PET imaging evidence demonstrating persistent and widespread microglial activation in an Alzheimer’s patient despite treatment with lecanemab, confirming that neuroinflammation remains present even after amyloid plaque reduction. Lecanemab, marketed by Eisai and Biogen as Leqembi®, is one of the two FDA-approved anti-amyloid therapies for treating early Alzheimer’s and is proven to reduce beta-amyloid plaques.
Dr. Howard Weiner, Chairman of Tiziana’s Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham, stated, “This PET finding is a critical insight: clearing amyloid does not turn off the brain’s inflammatory response. We believe intranasal foralumab directly addresses this residual neuroinflammation by inducing regulatory T cells to migrate to the brain and calm activated microglia — a mechanism we have already shown reduces microglial activation in secondary progressive multiple sclerosis.”
Phase 2 Trial Design and Rationale
The study will evaluate whether intranasal foralumab:
As a monotherapy, reduces microglial activation and slows cognitive decline by suppressing neuroinflammation.
In combination with lecanemab or donanemab will provide additive or synergistic benefit by simultaneously targeting amyloid pathology and persistent microglial inflammation.
“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,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. “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 c
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