Type: Portable inhaled nitric oxide system (iNO) for the treatment of COVID-19. INOpulse has generated positive top-line Phase II results in pulmonary hypertension associated with pulmonary fibrosis (PH-PF), with a pivotal Phase III trial planned.
Status: Bellerophon said July 13 the first patient had been treated in its Phase III COViNOX trial (formerly PULSE-CVD19-001; NCT04421508) of INOpulse at Banner University Medical Center, within the University of Arizona College of Medicine – Phoenix. The randomized, placebo-controlled study—set to enroll up to 500 patients at “major” U.S. hospitals—is designed to assess INOpulse in COVID-19 patients who require supplemental oxygen before the disease progresses to require mechanical ventilation support.
The trial’s primary endpoint will be the proportion of subjects that had respiratory failure or mortality, which according to Bellerophon should allow the trial to serve as a registrational study for approval. Overseeing the trial will be under the direction of Thomas Ardiles, MD, clinical assistant professor and Marilyn Glassberg, MD, professor of medicine and chief of the Pulmonary, Critical Care and Sleep Division
Bellerophon said it is awaiting word from the NIH and the Biomedical Advanced Research and Development Authority for funding to support the Phase III trial.
In May, the FDA accepted Bellerophon’s IND application after earlier allowing investigational treatment with INOpulse for COVID-19 patients under emergency expanded access. Under emergency access, 180 COVID-19 patients from 18 U.S. hospitals received treatment with INOpulse under the care and supervision of their physicians. Preliminary data showed that 14 days after the start of treatment, the recovery rate was 73.0% and mortality rate was 6.3%. INOpulse was well-tolerated with no safety concerns related to the therapy, Bellerophon added.
In March, the company said it treated its first COVID-19-diagnosed patient diagnosed with INOpulse at the University of Miami School of Medicine, after the FDA granted the company emergency expanded access allowing immediate use of the inhaled nitric oxide system to treat COVID19 patients under the care and supervision of their physician.
Bellerophon has noted that SARS-CoV-2 is approximately 82% identical to severe acute respiratory syndrome related coronavirus (SARS-CoV), the virus behind the 2003-04 global SARS outbreak. The company cited past studies showing that nitric oxide could benefit SARS-CoV patients by preventing viral replication, improving arterial oxygenation, reducing the need for ventilation support, and preventing the proliferation of lung infiltrates.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: