Direct Biologics has announced positive topline results from its EXIT COVID-19 Phase II clinical trial, evaluating ExoFlo for the treatment of COVID-19-related Acute Respiratory Distress Syndrome (ARDS). The multicenter, double-blind, placebo-controlled, randomized trial demonstrated a significant reduction in mortality and improved clinical outcomes with ExoFlo treatment.
Key Findings of the EXIT COVID-19 Trial
The study revealed a 37.6% reduction in the 60-day mortality rate among patients treated with ExoFlo compared to those receiving a placebo. Furthermore, ExoFlo demonstrated superiority over placebo in terms of reducing the time to discharge and increasing ventilator-free days. A subgroup analysis indicated an even more pronounced mortality benefit in patients who presented with severe hypoxia at the time of randomization.
According to Dr. Vikram Sengupta, Chief Medical Officer of Direct Biologics, ExoFlo exhibited a "robust safety and efficacy profile," warranting further investigation in a pivotal Phase III study. No reportable adverse events were observed during the Phase II trial.
ExoFlo: A Novel Approach to ARDS Treatment
ExoFlo is an acellular product derived from human bone marrow mesenchymal stem cells (MSCs). It contains signaling molecules that harness the anti-inflammatory and regenerative properties of MSCs without the challenges associated with stem cell transplantation. This innovative approach offers a potential solution to the unmet need for effective ARDS therapies.
The Unmet Need in COVID-19 ARDS
Despite advancements in medical care, ARDS due to COVID-19 remains a leading cause of death in the United States. The emergence of new variants, such as BA.2, has the potential to trigger further waves of hospitalizations. Dr. Sascha Sengupta, Associate Chief Medical Officer, emphasized the urgent need for novel therapeutics like ExoFlo to address this critical problem.
Direct Biologics is dedicated to exploring additional clinical applications of ExoFlo through the FDA's investigational new drug application process.
