Tiziana Life Sciences Ltd. (Nasdaq: TLSA), a biotechnology company developing immunomodulation therapies through innovative drug delivery methods, announced plans to investigate the use of Intranasal Foralumab for treating Long COVID. This decision is supported by Foralumab established role in deactivating microglia cells, a key component in the pathophysiology of this disease.
Upon receiving positive feedback from the FDA, Tiziana anticipates entering into a Phase 2a placebo-controlled clinical trial, as stated by Matthew W. Davis, M.D., RPh, Chief Medical Officer of Tiziana. The trial will assess the effectiveness of intranasal foralumab in patients with Long COVID using PET Scans to determine changes in activated microglia after 3 months of administration. Tiziana plans to file an IND in 4Q 2023 after refining their clinical protocols and discussing the approach with the FDA.
Gabriele Cerrone, Executive Chairman and interim Chief Executive Officer of Tiziana, emphasized the urgent need for effective treatments for Long COVID, which affects over 9 million people in the U.S. and poses a significant economic burden on the healthcare system. Tiziana believes that intranasal foralumab, with its ability to modulate activated microglia, could be a promising therapeutic approach for this debilitating condition and other inflammatory diseases.
Howard L. Weiner, M.D., Chairman of Tiziana’s Scientific Advisory Board, highlighted the established role of activated microglia in the pathogenesis of Long COVID and shared research findings from studies using intranasal foralumab in other conditions. He believes that foralumab has the potential to be a novel treatment for Long COVID by modulating activated microglia and returning effector T cells to a naïve state.
What is Foralumab?
Foralumab is a fully human anti-CD3 monoclonal antibody that dampens inflammation by modulating T cell function. It has shown favorable safety and clinical response in patients in previous studies for COVID-19 and multiple sclerosis. Phase 2 trials for intranasal foralumab are expected to commence in the third quarter of 2023 in patients with non-active Secondary Progressive Multiple Sclerosis (SPMS), representing a novel avenue for immunotherapy.
Tiziana Life Sciences is a clinical-stage biopharmaceutical company that develops therapies using transformational drug delivery technologies for alternative routes of immunotherapy. Their intranasal approach aims to improve efficacy, safety, and tolerability compared to intravenous delivery. Intranasal foralumab, their lead candidate, has demonstrated promising results in clinical studies, and Tiziana’s patented technology is expected to have broad applications in their pipeline
- Neuron. 2022 Nov 2; 110(21): 3484–3496.
- Oxford Open Immunology, Volume 3, Issue 1, 2022, iqac007
- N Engl J Med 2022; 387:1813-1815
- Neuron 110, November 2, 2022:3484-3496
- Front. Cell. Neurosci., 15 June 2021;Sec. Non-Neuronal Cells: Volume 15
- Molecular Psychiatry (2022) 27:3939 – 3950
- Boldrini M, Canoll PD, Klein RS. How COVID-19 Affects the Brain. JAMA Psychiatry. 2021;78(6):682–683. doi:10.1001/jamapsychiatry.2021.0500