Windtree Therapeutics has announced that it plans to study its KL4 surfactant for the treatment of acute respiratory distress syndrome (ARDS) in patients suffering from COVID-19. Windtree’s Aerosurf — KL4 delivered via the company’s proprietary Aerosol Delivery System (ADS) — is in development for the treatment of respiratory distress syndrome (RDS) in premature infants. In 2017, the company published results from a pre-clinical study suggesting that aerosolized KL4 showed promise for the treatment of lung injuries from influenza.
According to Windtree, lung injuries seen in COVID-19 patients are similar to those seen in premature infants who develop bronchopulmonary dysplasia after being ventilated due to RDS. Previous studies have shown that surfactant replacement could potentially decrease inflammation in the lungs and improve lung function in those cases, with the goal of decreasing the need for mechanical ventilation and possibly decreasing mortality.
Windtree Senior VP and Chief Medical Officer Steve Simonson explained why the company believes that KL4 holds potential for the treatment of COVID-19 ARDS: “Patients with COVID-19 pneumonia may progress to severe respiratory failure requiring supplemental oxygen and mechanical ventilation. This acute lung injury, known as acute respiratory distress syndrome (ARDS), has no approved therapies and is associated with significant morbidity, mortality and healthcare resource utilization. The COVID-19 virus infects the specific cells that make pulmonary surfactant and is believed to result in inadequate levels of functional surfactant. We believe this mechanism of injury may differentiate COVID-19 lung injury from other etiologies of ARDS and is the basis for a potentially important role for our KL4 surfactant. Numerous preclinical studies have shown positive effects of our KL4 surfactant in various models of severe lung injury and our clinical studies have demonstrated beneficial effects in respiratory distress syndrome in premature infants leading us to believe there may be potential to provide benefit in patients with severe COVID-19 lung injury.”
In addition to its own planned studies, Windtree said that it is assisting Lee’s Pharma, which acquired the Asian rights to the KL4 surfactant in 2017, with possible studies of KL4 surfactant in Chinese COVID-19 patients. The company also said that it is looking for funding for the studies from private foundations and government agencies.
Windtree CEO Craig Fraser commented, “Our company is committed to help minimize the devastating impact of this virus. With the appropriate funding, we plan to initiate a pilot study to assess KL4 surfactant’s ability to impact key respiratory parameters in ventilated COVID-19 patients. Depending on the results, we would be prepared to move forward in this indication very quickly.”
Read the Windtree Therapeutics press release.
