Bonus Biogroup Receives Approval for MesenCure in Acute Respiratory Distress Syndrome Treatment
Friday, February 21, 2025
Bonus Biogroup has received clearance from the United States Food and Drug Administration (FDA) to proceed with a Phase III clinical study.
ARDS can develop due to pneumonia, sepsis, or trauma, often resulting in respiratory failure and a high mortality rate. In severe COVID-19 cases, respiratory distress can lead to ARDS or worsen existing conditions.
Despite advancements in supportive care, ARDS remains a major challenge, with mortality rates ranging between 27% and 45%. In 2023, approximately 591,000 people in the United States were affected by ARDS, accounting for 10% to 15% of ICU admissions.
More than 75% of survivors experience long-term complications, leading to additional healthcare costs estimated at $43,000 to $62,000 per patient in the years following their illness.
MesenCure is an investigational allogeneic cell therapy consisting of enhanced MSCs derived from adipose tissue. It has been developed to address inflammation and tissue damage in conditions such as pneumonia and respiratory distress.
Unlike other treatments that target the specific causes of inflammation, MesenCure focuses on reducing lung inflammation and restoring tissue function, making it potentially applicable across a wide range of respiratory distress cases.
The trial will evaluate the efficacy and safety of MesenCure, an allogeneic cell therapy derived from enhanced adipose tissue MSCs, in treating respiratory distress in hospitalised patients with severe illness due to COVID-19-related pneumonia. MesenCure is designed to address inflammation and tissue damage in affected patients.
The company aims to expand the trial’s scope to include respiratory distress caused by various conditions, including acute respiratory distress syndrome (ARDS).
Clinical and preclinical findings suggest that MesenCure may have therapeutic potential regardless of the underlying cause.
The FDA clearance follows results from a Phase II clinical study completed in 2022, which showed a 68% reduction in the 30-day all-cause mortality rate among hospitalised COVID-19 pneumonia patients treated with MesenCure.
Bonus Biogroup remains committed to advancing the Phase III clinical study and making MesenCure available as a potential treatment option for patients suffering from acute respiratory distress.
Source: globenewswire.com
