Tiziana Life Sciences Ltd. announced it plans to investigate intranasal foralumab for the treatment of Long COVID. The work is supported by foralumab’s well-established role in de-activating microglia cells, a key component in the pathogenesis of this disease.
“We anticipate entering into a Phase 2a placebo-controlled clinical trial upon successful feedback from the FDA”, commented Matthew W. Davis, M.D., RPh, Chief Medical Officer of Tiziana. “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.”
“Long COVID constitutes an unmet need in society. The estimated over 9 million people in the U.S. 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,” commented Gabriele Cerrone, Executive Chairman and interim Chief Executive Officer of Tiziana. “The ability to modulate pathogenic activated microglia may have many applications in inflammatory disease states.”
Howard L. Weiner, M.D., 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, stated, “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.”