FDA approves Phase III Acute Respiratory Distress Syndrome (ARDS) Trial

pharmafile | April 22, 2022 | News story | Medical Communications  

The FDA has approved Direct Biologics to proceed with its Phase III clinical trial into the treatment of Acute Respiratory Distress Syndrome (ARDS) due to COVID-19.

The company is the first and only extracellular vesicle (EV) platform to receive FDA Phase III approval for an Investigational New Drug (IND) indication to date.

The Phase III trial will be conducted under the auspices of the first Regenerative Medicine Advanced Therapy (RMAT) designation, approved by the FDA for an EV therapeutic. The RMAT was created by the FDA to expedite approval for promising regenerative medicines which show promise in treating serious life-threatening diseases.

“Whether COVID-19 remains a pandemic or becomes an endemic, one area of unmet need remains the same: an effective therapeutic for ARDS. People over age 65 and those with comorbidities, once infected with SARS-CoV-2, will always be vulnerable to progression to severe infection and ARDS,” said Joe Schmidt, Co-Founder and President. “Revealing robust safety and a promising 60-day mortality reduction, our Phase II trial showed that ExoFlo can make a profound life-saving difference for patients hospitalised with ARDS. Receiving FDA approval to proceed to Phase III is a monumental achievement because there is no known treatment for ARDS. Physicians and patients across the world have long been waiting for a solution.”

“Working to develop ExoFlo is a privilege,” said Dr Vik Sengupta, CMO. “The growing body of clinical data indicates that ExoFlo is a drug that brings hope to the treatment of a disease for which the standard of care has not improved in decades. This hope is most poignantly captured by the stories of patients who have received ExoFlo for treatment. Just last week, a woman in Virginia was reunited with her children after languishing on mechanical ventilator for 2 months due to developing ARDS induced by COVID-19. But in a final attempt to save the patient’s life, the ICU physicians petitioned to treat her with ExoFlo under compassionate use, and she made a miraculous recovery. There are millions of people like her who never make it out of the hospital. We want to change that story by establishing ExoFlo as the gold standard treatment for ARDS and making it accessible to patients in hospitals around the world.”

Lina Adams

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