Tiziana Life Sciences Announces Long Covid Study to Complete in Second Quarter
February 25, 2025 – Biotechnology, Clinical Trials, Drug Discovery, Other – Long COVID-19, Tiziana Life Sciences, clinical trials, immunomodulation therapies, monoclonal antibodies
25 February 2025 — New York, US — Tiziana Life Sciences, Ltd, a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that a nasal anti-CD3 (foralumab) preclinical study is nearing completion, and that foralumab could offer a novel and effective treatment for long COVID. This innovative approach works by reducing microglial activation, a key factor in the persistent brain inflammation associated with long COVID, thereby addressing the debilitating neurological and psychiatric symptoms many patients face.
Long COVID is a complex and often debilitating complication following COVID-19 infection. It affects millions worldwide, presenting with symptoms such as persistent fatigue, cognitive impairment (“brain fog”), and psychiatric issues like depression. A growing body of evidence highlights that long COVID is linked to sustained brain inflammation and microglial activation, which disrupts normal brain function. PET imaging studies confirm increased microglial activity in individuals suffering from long COVID, underlining the urgent need for targeted therapies.
Previously, Tiziana conducted a human clinical study in patients with mild to moderate COVID-19 where foralumab was nasally administered once a day for 10 consecutive days. Treatment was well-tolerated and produced significant reduction in lung inflammation as assessed by computerized tomography (CT) scanning. The aim of the human study was to assess safety of intranasal Foralumab and evaluate its potential benefits in treating immune hyperactivity and lung inflammation who were outpatients at the Santa Casa de Misericordia de Santos Hospital in Brazil.
Tiziana’s nasal anti-CD3 platform has previously demonstrated efficacy in reducing microglial activation in models of central nervous system (CNS) diseases, including multiple sclerosis (MS) and Alzheimer’s Disease.
“Long COVID has challenged the medical community with its complexity, but targeting microglial activation through nasal anti-CD3 presents a promising therapeutic avenue,” commented Tiziana’s CEO, Ivor Elrifi. “A study in secondary progressive multiple sclerosis showed both clinical improvement and decreased microglial activation via TSPO PET imaging, providing a solid foundation for this Long COVID hypothesis. Importantly, nasal anti-CD3 was well tolerated, with no serious adverse events.”
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 currently in clinical development, 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. For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com
