Tiziana and FHI Clinical enter a collaboration agreement for a phase 2 clinical trial of intranasal Foralumab to treat hospitalized patients with severe COVID-19

Tiziana Life Sciences plc, a biotechnology company focused on innovative therapeutics for oncology, neurology, inflammation and infectious diseases, announced that it signed an agreement with FHI Clinical to conduct a Phase 2 proof-of-concept study in Brazil to evaluate the safety, tolerability and efficacy of intranasal Foralumab in hospitalized patients with severe COVID-19 and pulmonary inflammation.

Nasal administration of Foralumab is a highly innovative approach to treat patients with autoimmune diseases where the immune system may be dysregulated. Several studies have suggested that there is dysregulation in the immune system of patients with COVID-19.

This randomized, placebo-controlled, double-blind, proof-of-concept study is designed to expand on the preliminary findings of safety, tolerability and efficacy of intranasal administration of Foralumab previously observed in non-hospitalized patients with mild to moderate COVID-19. The study will be conducted at up to seven sites in Brazil and enroll 80 hospitalized patients with severe COVID-19 and evidence of pulmonary involvement on a computed tomography (CT) scan at screening. Patients will be randomized 1:1 to receive intranasal Foralumab 100 µg or placebo. Additionally, the study will evaluate the effect of Foralumab on resolution of symptoms by chest CT, inflammatory biomarkers, T-cell subpopulations, safety and mucosal inflammatory response following 14 days of intranasal administration.