Tiziana Life Sciences; Phase 2, U.S.
On December 17, 2025, Tiziana Life Sciences reported dosing of the first patient in a randomized Phase 2 U.S. trial evaluating intranasal foralumab, an anti-CD3 monoclonal antibody, in early Alzheimer's disease.
source: tizianalifesciences.com
Evaluates foralumab as monotherapy and in combination with anti-amyloid antibodies
Intranasal administration for direct CNS access
source: tizianalifesciences.com
Addressing Persistent Neuroinflammation:
The trial builds on earlier findings suggesting intranasal foralumab may reduce neuroinflammation by modulating microglial activity, potentially addressing disease mechanisms that persist beyond amyloid clearance.
source: tizianalifesciences.com
While anti-amyloid therapies have shown efficacy in clearing amyloid plaques, ongoing neuroinflammation may continue to drive disease progression. Combining foralumab's immunomodulatory effects with amyloid-targeting therapies could offer a more comprehensive treatment approach for Alzheimer's patients.
Combination trials in Alzheimer's disease require complex patient stratification and sites experienced with anti-amyloid therapy protocols. Kitsa's platform can support:
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