Fulcrum Initiates P-III LOSVID Study Evaluating Losmapimod for Patients Hospitalized with COVID-19

 Fulcrum Initiates P-III LOSVID Study Evaluating Losmapimod for Patients Hospitalized with COVID-19

Fulcrum Initiates P-III LOSVID Study Evaluating Losmapimod for Patients Hospitalized with COVID-19

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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