The therapeutic hypothesis for the use of losmapimod in COVID-19 disease is that increased
mortality and severe disease is caused by p38 mitogen-activated protein kinase
(MAPK)-mediated exaggerated acute inflammatory response resulting from SARS-CoV-2 infection.
The study Sponsor hypothesize's that the early initiation of p38α/β inhibitor therapy in
patients hospitalized with moderate COVID-19 who are at increased risk of a poor prognosis
based on older age and elevated systemic inflammation will reduce clinical deterioration
including progression to respiratory failure and death.
To address this hypothesis, Fulcrum Therapeutics is conducting a Phase 3, multicenter,
randomized, double-blind, placebo-controlled study that will evaluate the safety and efficacy
of losmapimod versus placebo in subjects 50 and older who are hospitalized with moderate
COVID-19 disease.