FDA permits study of local company drug to prevent COVID-19 patients from needing ventilators
SAN DIEGO (KUSI) – The FDA is allowing some COVID-19 patients access to a new developmental drug, made out of San Diego, that could prevent them from needing ventilators. This comes as hospitals across the country report shortages of critical equipment—like ventilators, and reports indicate atleast half of COVID-19 patients on ventilators don’t make it.
The drug, CM4620-IE, will be given through an IV (intravenously) to patients who have severe COVID-19 pneumonia. It aims to keep them from ‘crashing’ even though their ability to breath on their own may be declining. The developmental drug is potent and acts fast to block the production and release of pro-inflammatory cytokines from immune cells. These cytokines play a role in initiating the body’s inflammatory response and lead to respiratory distress in COVID-19 patients.
San Diego based company, CalciMedica is developing this drug and is dosing patients today at Regions Hospital in St. Paul, MN and plans to start dosing at Henry Ford Hospital in Detroit, MI within the next week.
“There is a dire need for a fast-acting, potent treatment for patients with severe COVID-19 pneumonia,” said Charles A. Bruen, M.D., a critical care and emergency physician at Regions Hospital in St. Paul, Minnesota. “Recent clinical studies demonstrated safety and potential efficacy of CM4620-IE in critically ill patients with acute pancreatitis. Its rapid onset makes it ideal for acute settings. It has the potential to prevent the development of ARDS in patients with severe COVID-19 pneumonia and reduce the need for ventilators at a time when there is a shortage of ventilators in healthcare facilities across the U.S.”
CalciMedica CMO Sudarshan Hebbar, M.D., joined Good Morning San Diego to provide more details on the clinical trial and what differentiates CM4620-IE from other therapies.