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FDA has accepted Airway’s investigational new drug application for the development of its novel human recombinant protein, AT-100 (rhSP-D), as a treatment for COVID-19.
Airway Therapeutics, a US-based biopharmaceutical company, announced on April 12, 2021 that FDA has accepted its investigational new drug (IND) application for the development of its novel human recombinant protein, AT-100 (rhSP-D), as a treatment for COVID-19.
Following the IND acceptance, the company will begin a Phase Ib clinical trial to determine the feasibility of intratracheal administrations of AT-100 and its safety and tolerability profile, Airway said in a company press release. In previous preclinical studies, the protein reduced inflammation and infection while regulating immune response for multiple respiratory diseases inside and outside the lung. Studies have also shown AT-100 has the potential to prevent SARS-CoV-2 duplication and promote viral elimination while reducing secondary infections in COVID-19 patients who are ventilated in intensive care.
“The pre-clinical data are encouraging and lead us to believe that AT-100 has therapeutic potential against COVID-19 by reducing infection and inflammation in mechanically ventilated seriously-ill patients who require a range of treatment options,” said Marc Salzberg, MD, CEO of Airway, in the press release. “We are excited to advance the clinical development of AT-100 with the goal of delivering a novel therapy for severely ill COVID-19 patients who are in need of new treatment options.”