Bellerophon Submits Investigational New Drug Application

IND Submission Follows Completed Treatment of Several COVID-19 Patients with INOpulse Under FDA Authorized Emergency Expanded Access Program

Warren-based Bellerophon Therapeutics, Inc., a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to study the INOpulse® inhaled nitric oxide system (iNO) for the treatment of patients infected with COVID-19. INOpulse is the only therapy to deliver targeted nitric oxide by autonomously adjusting to the patient’s breathing pattern to ensure accurate and consistent drug delivery into the airways.

The proposed randomized, open-label study, called PULSE-CVD19-001, will evaluate the efficacy and safety of INOpulse in patients with COVID-19 who require supplemental oxygen. 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 INOpulse or standard of care. In parallel, the company has applied for federal funding, through BARDA (Biomedical Advanced Research and Development Authority) and NIH (National Institutes of Health), to support the proposed IND study.

“As the U.S. continues to face a public health crisis related to COVID-19, it’s important that we progress our research efforts to expand INOpulse treatment to more patients and gather the necessary data through a formal IND study,” said Hunter Gillies, M.D., Chief Medical Officer at Bellerophon Therapeutics. “INOpulse is the only technology able to deliver consistent and accurate doses of nitric oxide to the lungs based specifically on each patient’s real-time breathing patterns, and we believe our IND submission represents a significant step forward as we aim to improve clinical outcomes and reduce the number of patients requiring assisted ventilation.”

The IND submission follows agreement by the FDA to allow treatment with INOpulse for COVID-19 patients under an emergency expanded access program. To date, three COVID-19 patients have completed treatment with INOpulse, with several additional patients currently on the INOpulse therapy.

“We are pleased to report that the three COVID-19 patients that completed INOpulse treatment to date have already demonstrated improved oxygenation that allowed them to avoid the need for mechanical ventilation and two of the patients have already been discharged. We continue to collaborate closely with the FDA and medical centers around the country to make INOpulse available to as many patients as possible as quickly as we can,” continued Dr. Gillies.

COVID-19 is caused by the SARS-CoV-2 coronavirus, which is approximately 82% identical to the severe acute respiratory syndrome related coronavirus (SARS-CoV) that caused a global outbreak between 2003 and 2004¹. Prior studies have shown that nitric oxide (NO) could provide benefit in treating SARS-CoV by preventing viral replication², improving arterial oxygenation, reducing the need for ventilation support and preventing the proliferation of pneumonia lung infiltrates³. Based on 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.

Nitric oxide is a naturally produced molecule as part of the immune response to pathogens and plays a key role in preventing viral replication. The proprietary INOpulse delivery system from Bellerophon Therapeutics is an investigational system that is portable and 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.

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