In June 2020, Fulcrum announced that it received early notification of authorization by the U.S. Food and Drug Administration (FDA) to initiate the LOSVID study, a Phase 3, randomized, double-blind, placebo-controlled trial of losmapimod in higher risk hospitalized adults with COVID-19. Losmapimod is an orally available selective p38α/β mitogen activated protein kinase (MAPK) inhibitor with extensive evidence of safety and tolerability in the clinic.
Several lines of preclinical and clinical evidence indicate that activation of p38 mitogen-activated protein kinase (MAPK) significantly contributes to the pathogenesis of coronavirus infections including SARS-CoV-2. p38 MAPK is also well known as an important mediator of acute response to stress, including acute inflammation.
Fulcrum believes that losmapimod has the potential to treat COVID-19 by reducing the acute exaggerated pro-inflammatory responses to SARS-CoV-2 infection and restoring the antigen-specific immune responses needed for clearance of SARS-CoV-2 in individuals at risk of progression to critical illness based on older age and elevated systemic inflammation. Additionally, p38 inhibition has been demonstrated to reduce angiotensin II (Ang II)-induced endothelial and organ damage in several experimental models and may address the renin-angiotensin system imbalance that is believed to contribute to key morbidities in COVID-19 patients. Lastly, emerging evidence points to the potential for p38 inhibition in having a direct antiviral activity against SARS-CoV-2.
The LOSVID trial will include an interim analysis conducted in the fourth quarter of 2020 for futility and sample size re-estimation by an independent data monitoring committee. Topline data is expected to be reported in the first quarter of 2021.
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