Medregen is excited to announce that the FDA has approved our IND to initiate a phase IIa, dose-ranging study (NCT06308926) in Acute Respiratory Distress Syndrome: A PHASE IIA, DOUBLE-BLIND, RANDOMIZED, MULTI-CENTER STUDY COMPARING MRG-001 TO PLACEBO IN PATIENTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME (SUMMIT).
Acute Respiratory Distress Syndrome (ARDS) is a life-threatening condition where severe inflammation and fluid accumulation impair lung function, often resulting from infections or trauma. Mortality rates range from 30% to 50%, depending on the severity and patient factors. Despite advances in critical care, there are no specific pharmacological treatments, and management relies on supportive measures like mechanical ventilation. This underscores the urgent need for novel therapies such as MRG-001 to improve outcomes for ARDS patients.
In total, 60 patients will ARDS with a PaO2/FiO2 < 300 requiring respiratory support will be randomized to three groups: placebo (N=20), low-dose MRG-001 (N=20) and high-dose MRG-001 (N=20). Patients will be treated with a placebo or MRG-001 following randomization and continue to receive treatment for a total of 6 injections with early stopping in cases where patients are discharged from the ICU. Patients will be closely monitored for a total of 28 days for respiratory support, mortality, organ failure, and adverse events.
This is an international trial, that will be conducted in the United States and China.
