Acute lung injury (ALI) associated with COVID-19 is the most frequent cause of death related to the infection, with limited benefit shown from current treatments. ALI ensues following the triggering of the complement cascade and innate immune response. RLS-0071 downregulates both processes by acting on the earliest stages of the inflammatory cascade preventing escalation and tissue damage.
Preclinical data in our proprietary two-hit animal model shows dramatic decreases of inflammatory cytokines IL-1b, IL-6, IL-17, and TNFa after prophylactic or rescue dosing. RLS-0071 decreases neutrophil infiltration by 85% after single IV injection, preventing lung tissue damage.
In July 2020, ReAlta announced that the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application for RLS-0071 for the treatment of acute lung injury secondary to COVID-19. ReAlta expects to begin enrolling in the 2nd quarter of 2021 a Phase 1 randomized, double-blind, placebo-controlled clinical trial of RLS-0071 in adult patients with pneumonia and early respiratory failure.
In parallel, ReAlta is exploring the ability of RLS-0071 to treat acute lung injury triggered by other viral infections such as RSV and influenza, and in other acute pulmonary disease processes.
Normal lung histology 
Neutrophil infiltration and tissue damage 
Preserved lung histology after single dose of RLS-0071 
Acute lung injury (ALI) associated with COVID-19 is the most frequent cause of death related to the infection, with limited benefit shown from current treatments.
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