FDA Approves Phase III Study of Fulcrum's Losmapimod in COVID-19

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Shares of Fulcrum Therapeutics were up more than 14% in premarket trading after the company announced it will begin the Phase LOSVID III study to assess losmapimod as a potential treatment of COVID-19.

This morning Cambridge, Mass.-based Fulcrum said the U.S. Food and Drug Administration approved an investigational New Drug Application to test losmapimod in a placebo-controlled late-stage study that will 400 hospitalized adults with COVID-19. FDA approval was swift. Fulcrum announced its plans to seek approval for the study two weeks ago, the same day the company announced it secured $68.5 million from a private placement that will fund this study, as well as ongoing clinical research of losmapimod for facioscapulohumeral muscular dystrophy.

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Losmapimod is a selective p38α/β mitogen-activated protein kinase (MAPK) inhibitor that may impact multiple components of COVID-19. Robert J. Gould, president and chief executive officer of Fulcrum, said the company believes losmapimod has the potential to be a differentiated treatment option in the global fight against COVID-19. Preclinical and clinical studies indicate that losmapimod has the potential to reduce the acute exaggerated pro-inflammatory responses to SARS-CoV-2 infection and restore the antigen-specific immune responses that are needed to clear the virus. In previous clinical trials in chronic inflammatory conditions, losmapimod had an immediate effect on a number of inflammatory biomarkers that have been associated with poor prognosis in COVID-19, including C-reactive protein and interleukin-6, Fulcrum said in its announcement.  

“The speed with which we have advanced this program reflects our deep understanding of the mechanism of action of losmapimod, the pressing need for treatment options and the commitment of our team to develop therapies that result in meaningful outcomes for patients. We are encouraged by the feedback we have received from investigators, and we expect to have all sites participating in the trial to be activated in the coming weeks,” Gould said in a statement.

The Phase III LOVIS study will assess the safety and efficacy of a 15 mg twice per day oral dose of losmapimod compared to placebo for 14 days on top of standard of care in approximately 400 patients hospitalized with COVID-19 and at risk of progression to critical illness. The primary endpoint will be the proportion of patients who progress to death or respiratory failure by day 28 following initiation of treatment. Secondary endpoints include clinical status on days seven and 14, total number of days free of oxygen supplementation, all-cause mortality, length of hospitalization and ICU stay and viral clearance. Fulcrum expects to present an interim analysis of results in the fourth quarter of 2020 and topline data is expected to be reported in the first quarter of 2021.

Robert Finberg, a professor of medicine at the University of Massachusetts Medical School, said studies indicate that p38 inhibition can decrease inflammatory responses but enhance T-cell responses to a viral antigen. These results suggest that losmapimod could improve the pathology of COVID-19 in multiple ways, he said.

“Losmapimod is a promising treatment candidate that could address multiple key contributors to the pathogenesis of COVID-19 and already has an extensive amount of safety and tolerability data across multiple age groups, including the elderly. The rapid initiation of this pivotal trial reflects the data supporting this research and the pressing need for effective therapies that reduce the morbidity associated with COVID-19,” Finberg said.

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