The U.S. Food and Drug Administration (FDA) has notified Fulcrum Therapeutics Inc. (NASDAQ: FULC) that it is allowed to proceed with initiating its Phase 3 trial of losmapimod in higher risk hospitalized adults with COVID-19. Shares pushed higher on Wednesday on the news.

The Phase 3, international, multicenter Losvid trial is designed to assess the safety and efficacy of losmapimod versus a placebo for 14 days on top of standard of care in roughly 400 patients hospitalized with COVID-19 and at risk of progression to critical illness based on older age and elevated systemic inflammation.

The primary endpoint of the trial is the proportion of patients who progress to death or respiratory failure by day 28. Additional secondary endpoints include clinical status on days seven and 14 as measured on the nine-point WHO ordinal scale of COVID-19 severity, total number of study days free of oxygen supplementation, all-cause mortality, length of hospitalization and ICU stay, adverse events and viral clearance.

An interim analysis will be conducted in the fourth quarter of 2020, when approximately 50% of subjects complete the 28-day visit. Topline data is expected to be reported in the first quarter of 2021.

Robert J. Gould, Ph.D., president and CEO, noted that the speed at which the company advanced this program reflects the potential for losmapimod, as well as the pressing need for treatment options. He added that management so far has been encouraged by the feedback it has received from investigators, and it expects to have all sites participating in the trial to be activated in the coming weeks.

Fulcrum Therapeutics stock traded up about 11% to $20.83 on Wednesday, in a 52-week range of $4.37 to $22.96. The consensus price target is $26.40.

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