Abstract
Introduction: Patients with COVID-19 pneumonia can experience serious respiratory complications caused by an excessive T-cell mediated inflammatory response. ATYR1923 is novel immunomodulator that downregulates T-cell responses in models of immune-mediated acute lung injury. The effect of ATYR1923 on inflammatory/COVID-19 biomarkers was evaluated in a Phase 2 placebo-controlled study in COVID-19 pneumonia.
Methods: Patients hospitalized for COVID-19 pneumonia were randomized to receive placebo or ATYR1923 on top of standard of care (remdesivir/dexamethesone). Serum samples drawn pre-dose (day 1) and post-dose days 2, 3, and 5 were analyzed for 41 circulating biomarkers. A random coefficient regression model was fitted to each biomarker to obtain estimates of rate of change Day 1 to Day 5 by treatment.
Results: 32 subjects were treated with placebo (n=10), 1 mg/kg (n=10) or 3 mg/kg (n=12) ATYR1923. Compared to healthy control levels, 19 biomarkers were elevated prior to study drug treatment despite patients receiving prior/concurrent steroids. Compared to placebo, treatment with ATYR1923 3 mg/kg resulted in increased resolution of key elevated biomarkers by day 5.
Conclusions: COVID-19 patients treated with ATYR1923 had improved resolution of key biomarkers compared to placebo. These findings are consistent with ATYR1923 effects in preclinical models, supporting the therapeutic utility of ATYR1923 in inflammatory lung diseases.
Footnotes
Cite this article as: European Respiratory Journal 2021; 58: Suppl. 65, PA452.
This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2021