The US Food and Drug Administration (FDA) has accepted Airway Therapeutics’ Investigational New Drug (IND) application to develop AT-100 (rhSP-D) for treating Covid-19.
A new recombinant human protein rhSP-D, AT-100 is an engineered version of an endogenous protein that lowers inflammation and infection while moderating the immune response to disrupt the cycle of injury and inflammation.
Airway will begin a phase Ib clinical trial of AT-100 to analyse whether intratracheal administration of AT-100 is feasible and study its potential safety and tolerability profile.
Initial results from this trial will be reported in the third quarter of this year.
Airway Therapeutics CEO Marc Salzberg said: “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.
“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.”
According to data from preclinical studies, AT-100 safely lowered inflammation and infection while regulating the immune response in various respiratory diseases inside and outside the lung.
Furthermore, it has shown to possibly hinder SARS-CoV-2 replication and boost the elimination of the virus. In severe Covid-19 patients admitted to intensive care and need mechanical ventilation, AT-100 could also lessen secondary infections.
Airway is leveraging the FDA’s Coronavirus Treatment Acceleration Program (CTAP), which is aimed at assessing new treatments for the disease.
Last month, the company received the first FDA IND approval for developing AT-100 as a preventive treatment for the serious respiratory disease bronchopulmonary dysplasia (BPD) in very preterm infants.
The phase Ib clinical trial of the therapeutic in borderline personality disorder (BPD) subjects will commence soon.
AT-100 has received Orphan Drug Designation from the FDA and the European Medicines Agency (EMA).