Tiziana Life Sciences to File Alzheimer’s IND for Intranasal Foralumab in Q2 2023
- Application for
$3Mof non-dilutive funding for Phase 2a Alzheimer’s trial will be submitted in Q2 2023
- Tiziana guided by FDA Type “B” meeting comments on its scheduled Q2 2023 intranasal foralumab Alzheimer’s IND filing
- Alzheimer’s patients will be administered 3-months of intranasal foralumab to study effects on neuroinflammation caused microglia activation
“Following the FDA feedback from our protocol and development plans from the
“There are no FDA approved treatments for Alzheimer’s disease specific to the neuroinflammation caused microglia activation triggered by amyloid beta plaque,” commented
Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. Intranasal foralumab Phase 2 trials are expected to start in the third quarter of 2023 in patients with non-active SPMS. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of inflammatory human diseases.1
About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
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Source: Tiziana Life Sciences Ltd.