The drug was granted so-called fast-track status by the Food and Drug Administration in January, Dr. Steiner said. The purpose of the designation is to review rapid development and new treatments that address unmet medical needs and target serious or life-threatening conditions.
Dr. Steiner said the company plans to meet with the agency later this month and apply for emergency use authorization for subizabulin. An FDA spokesperson declined to comment, saying the agency has not confirmed, denied or commented on pending applications.
Company officials said no safety concerns related to the drug were identified during clinical trials.
“Despite being two and a half years into the battle, we are still working hard to bring highly effective drugs into the mix to treat this specific population of patients, and that is a pretty dramatic improvement in 60-day mortality,” Dr said. Michael Gordon, one of the trial investigators and chief medical officer at HonorHealth Research and Innovation Institute in Scottsdale, Ariz.
But Dr. Gordon cautiously hollowed out his optimism, saying he looked forward to seeing a more detailed analysis. Additional data was also being analyzed on Monday, including the proportion of treated patients without respiratory failure, the number of days they spent in intensive care, the length of their hospital stay and how long they were on mechanical ventilation.
“No one drug works for everyone,” Dr. Gordon said. “The benefit seen is mortality – who is alive and who is dying – not who is receiving oxygen, although I hope we will see improvements in other parameters as well.”
Patients in both arms of the multicenter trial received all standard care and treatment. Participants were in the United States, Brazil, Argentina, Mexico, Colombia and Bulgaria, and were infected with both Delta and Omicron variants. Dr. Gordon and company officials said the drug is effective regardless of the variant type.