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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Expanded access policy
We understand the urgent need of patients with few treatment options to gain access to therapies in development. Our goal, when possible, is to allow access to our investigational therapies through multiple channels when doing so does not disrupt or slow the commercialization process. Learn more about our expanded access policy.