Tiziana Life Sciences has announced that the company will develop intranasal foralumab for the treatment of long COVID. In August 2021, Tiziana announced positive results from a pilot study of intranasal foralumab in mild-to-moderate COVID. The nasal formulation is currently in development for the treatment of non-active secondary progressive multiple sclerosis, and the company recently announced that it would develop intranasal foralumab for the treatment of hemorrhagic stroke.
Tiziana Chief Medical Officer Matthew W. Davis said, “We anticipate entering into a Phase 2a placebo-controlled clinical trial upon successful feedback from the FDA. 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.”
Chairman of the Tiziana Scientific Advisory Board Howard L. Weiner commented, “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, 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 devastating condition.”
Read the Tiziana Life Sciences press release.
