Biotherapeutics company aTyr Pharma has announced positive topline results from its Phase II clinical trial of ATYR1923 in hospitalised Covid-19 patients.
aTyr Pharma’s lead therapeutic candidate, ATYR1923, is being developed as a potential inflammatory lung disease treatment.
The randomised, double-blind, placebo-controlled trial enrolled 32 hospitalised Covid-19 patients with severe respiratory difficulties, who did not need mechanical ventilation, at hospitals in the US and Puerto Rico.
The participants were randomised into 1:1:1 ratio to receive a single, intravenous (IV) dose of either 1 or 3mg / kg of ATYR1923 or placebo.
After receiving the drug, they were observed for 60 days.
The study evaluated the safety and checked for preliminary signs of activity of ATYR1923 versus placebo.
According to data from the trial, a single IV dose of ATYR1923 was generally safe and well-tolerated in both the treatment arms, meeting the primary safety endpoint.
No drug-related serious adverse events were observed during the trial.
Furthermore, patients receiving a single dose of 3mg / kg of ATYR1923 experienced a median time to recovery of 5.5 days versus six days in the placebo arm.
In addition, 83% of participants who received the higher drug dose recovered by day six versus 56% in the placebo arm.
aTyr Pharma president and CEO Sanjay Shukla said: “We are pleased with the results of this study which continue to demonstrate ATYR1923’s favourable safety profile in inflammatory lung conditions.
“We are very encouraged by the signal of clinical activity seen in the 3mg / kg cohort of ATYR1923.
“The relatively faster time to recovery seen by adding a single dose of ATYR1923 to standard of care treatment and the greater proportion of patients recovering within a week compared to placebo give us further confidence in this signal.”