Tiziana Life Sciences Ltd (NASDAQ:TLSA) has announced plans to investigate intranasal foralumab for the treatment of Long COVID, work which is supported by foralumab’s well-established role in de-activating microglia cells, a key component in the pathogenesis of the disease.
“We anticipate entering into a Phase 2a placebo-controlled clinical trial upon successful feedback from the FDA”, commented Dr Matthew W. Davis, chief medical officer of Tiziana in a statement.
“I am excited to test intranasal foralumab in this medically important condition. The use of PET Scans will allow us to determine if intranasal foralumab will decrease activated microglia in patients with Long COVID after 3 months of administration. After refining our clinical protocols, we need to discuss this approach with the FDA and plan to file an IND in 4Q 2023,” he added.
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.
“Long COVID constitutes an unmet need in society. The estimated over 9 million people in the US with Long COVID will cost the healthcare system a projected $2.6 trillion dollars. I believe there is substantial evidence to support further study of intranasal foralumab in this debilitating and economically disruptive condition. The ability to modulate pathogenic activated microglia may have many applications in inflammatory disease states,” added Gabriele Cerrone, executive chairman and interim chief executive officer of Tiziana.
Intranasal foralumab Phase 2 trials are expected to start in the third quarter of 2023 in patients with non-active secondary-progressive multiple sclerosis (SPMS). Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for the treatment of inflammatory human diseases.
Dr Howard L. 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 Healthcare System, noted: “The role of activated microglia is well-established in the pathogenesis of Long COVID. Our research using intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis (SPMS), patients with COVID-19 and in healthy volunteers showed induction of a tolerogenic immune response by stimulating T regulatory cells while dampening CD3+ T effector function. In essence, intranasal foralumab modulates activated microglia while returning effector T cells to a naïve state. If this finding is replicated in patients with Long COVID, I believe that foralumab could represent a novel treatment for this devasting condition.”
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Its 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 has demonstrated a favorable safety profile and clinical response in patients in studies to date. The company's technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
Contact the author at jon.hopkins@proactiveinvestors.com