WARREN, N.J.—Bellerophon Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application. Now Bellerophon will be able to initiate a Phase 3 study of INOpulse inhaled nitric oxide therapy in patients infected with COVID-19.
The IND acceptance follows an earlier agreement by the FDA to allow investigational treatment with INOpulse for COVID-19 patients under emergency expanded access. To date, over 50 patients with COVID-19 have received treatment with INOpulse under the care and supervision of their physicians.
Bellerophon’s INOpulse is an investigational delivery system designed to deliver nitric oxide in a targeted, pulsatile manner that ensures accurate drug delivery and allows for use in outpatient settings outside of the hospital. Nitric oxide is a powerful vasodilator. It improves arterial oxygenation and, as part of the immune response to pathogens, plays a key role in preventing viral replication.
The Phase 3 study, called PULSE-CVD19-001, will evaluate the efficacy and safety of INOpulse in patients diagnosed with COVID-19 who require supplemental oxygen before the disease necessitates mechanical ventilation support. The PULSE-CVD19-001 protocol utilizes an adaptive design, and aims to enroll up to 500 patients with COVID-19 who will be treated with either INOpulse or placebo.
The primary endpoint of the study will assess the proportion of subjects who had respiratory failure or mortality, which should allow the trial to serve as a registrational study for approval. Bellerophon has applied for federal funding to support the study through the Biomedical Advanced Research and Development Authority and the National Institutes of Health.
“The acceptance of our Phase 3 study for the treatment of patients infected with COVID-19 represents a major advancement in our clinical development program and enables us to gather the required clinical data for potential regulatory approval of INOpulse for patients with COVID-19,” said Fabian Tenenbaum, chief executive officer of Bellerophon. “Under the emergency expanded access program, we have been encouraged by the improvements in patients with COVID-19 treated with INOpulse, reinforcing the potential for our propriety therapy to improve oxygenation in patients and halt the progression of the virus. We look forward to working with institutions across the United States to enroll patients into this important clinical trial and accelerate access to patients in need.”
Prior studies have shown that nitric oxide could provide benefit in treating SARS-CoV by preventing viral replication, improving arterial oxygenation, reducing the need for ventilation support and preventing the proliferation of pneumonia lung infiltrates. Because of the genetic similarities between the two coronaviruses, the historical data in SARS-CoV support the potential for iNO to provide meaningful benefit for patients infected with COVID-19.