Candidate: INOmax® (nitric oxide)

Type: Inhaled nitric oxide (iNO) indicated in the U.S. for term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension.

Status: Mallinckrodt said April 30 it was supporting an investigator-initiatived Phase II trial (NCT04306393) at Massachusetts General Hospital assessing INOmax in patients with severe acute respiratory syndrome due to COVID-19. The primary outcome measure of the estimated 200-patient study is change of arterial oxygenation in patients after 48 hours of treatment. Secondary objectives include evaluating the time it takes for patients who are breathing air to reach normoxia for at least 24 hours; the proportion of patients who achieve normoxia during the first 28 days after enrollment; and the patient survival rate at 28 days and 90 days.

In Apri1, Mallinckrodt said it was working with the FDA to make INOmax available to U.S. patients with pulmonary complications of COVID-19 “as quickly as possible through the appropriate regulatory mechanism.” Also, Mallinckrodt and Novoteris received approval from Health Canada to begin a pilot trial of high-dose inhaled nitric oxide therapy to treat COVID-19 and associated lung complications. Enrollment is expected to begin “in the coming days.”

The company cited a 2005 in vitro study showing iNO’s inhibitory effect on the replication cycle of severe acute respiratory syndrome-related coronavirus (SARS-CoV), and a 2004 study showing improved blood oxygenation, reduced supplemental oxygen, and reduced ventilator support in six SARS-CoV patients treated with iNO.

Mallinckrodt said it had submitted information to the NIH about evaluating iNO in acute respiratory distress syndrome (ARDS), informed the Biomedical Advanced Research and Development Authority (BARDA) of its ongoing study, and begun early talks with the FDA on submitting a pre-IND package in support of the potential use of iNO in coronavirus-associated ARDS.

Marketed in the U.S. since 2000, INOmax is indicated for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension.

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: