Shots:

• The P-III LOSVID study assess the safety and efficacy of losmapimod (15mg- bid) vs PBO for 14 days on top of SOC in ~400 patients hospitalized with COVID-19 and at risk of progression to critical illness based on older age and elevated systemic inflammation
• The 1EPs of the study is the proportion of patients who progress to death or respiratory failure by day 28 while 2EPs include clinical status on days 7 & 14 as measured on the nine-point WHO ordinal scale of COVID-19 severity- the total number of study days free of oxygen supplementation- all-cause mortality- length of hospitalization/ ICU stay- AEs and viral clearance
• The company plans to conduct an interim analysis for futility and sample size re-estimation by an independent data monitoring committee when ~50% of subjects complete the 28-day visit with its anticipated results in Q1’21. Losmapimod is an orally available selective p38α/β MAPK inhibitor

Click here to read full press release/ article | Ref: PRNewswire | Image: Fulcrum Therapeutics