The US Food and Drug Administration (FDA) has approved Investigational New Drug (IND) application submitted by Airway Therapeutics to develop AT-100 (rhSP-D) for treating patients with Covid-19.
AT-100 is a new recombinant human protein rhSP-D and is an engineered version of an endogenous protein that reduces inflammation and infection while modulating the immune response to cut the cycle of injury and inflammation.
Airway will commence a Phase Ib clinical trial of AT-100 to confirm the feasibility of intratracheal administration of AT-100 and study its potential safety and tolerability profile.
Initial results from this trial will be reported in Q3 2021.
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.”
As per the data from preclinical studies, AT-100 safely reduced inflammation and infection while regulating the immune response in several respiratory diseases within and outside the lungs.
AT-100 has shown to possibly inhibit SARS-CoV-2 replication and boost its elimination. The drug could also lessen secondary infections in patients suffering from severe Covid-19 and admitted to intensive care and in need of mechanical ventilation.
The firm is leveraging the FDA’s Coronavirus Treatment Acceleration Program (CTAP), which is aimed at evaluating new treatments options for Covid-19 disease.
In March 2021, the firm secured its first IND approval from the FDA for developing AT-100 as a preventive treatment for the serious respiratory disease bronchopulmonary dysplasia (BPD) in very preterm infants.
The Phase Ib clinical study of the therapeutic in borderline personality disorder (BPD) subjects is set to initiate soon.
The firm secured Orphan Drug Designation from the FDA and the European Medicines Agency (EMA) for AT-100.