aTyr Pharma Inc has completed the target enrollment in its Phase 1b/2a clinical trial of its lead therapeutic candidate, ATYR1923, in patients with pulmonary sarcoidosis, a form of interstitial lung disease (ILD).
Results of this study of 36 enrolled patients will inform future development for ATYR1923 in ILD, which may include a registrational trial in pulmonary sarcoidosis and expansion into trials for other forms of ILD.
aTyr is developing ATYR1923 as a potential therapeutic for patients with inflammatory lung diseases. ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory disease states. aTyr is currently enrolling a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis, a form of interstitial lung disease. This Phase 1b/2a study is a multi-ascending dose, placebo-controlled, first-in-patient study of ATYR1923 that has been designed to evaluate the safety, tolerability, steroid sparing effect, immunogenicity and pharmacokinetics profile of multiple doses of ATYR1923. In response to the COVID-19 pandemic, aTyr initiated and completed enrollment in a Phase 2 clinical trial with ATYR1923 in COVID-19 patients with severe respiratory complications. This Phase 2 study is a randomized, double blind, placebo-controlled study that has been designed to evaluate the safety and preliminary efficacy of a single dose of ATYR1923.
“We are pleased to meet the target enrollment of this important study, especially during the COVID-19 pandemic. Reaching this significant milestone for our ATYR1923 clinical program and the interest we’ve seen from patients to join the trial highlights the need for new therapies for this chronic, debilitating disease,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “We look forward to sharing the results in the third quarter of next year, which will provide meaningful insights into ATYR1923’s therapeutic potential in patients with pulmonary sarcoidosis and other major immune-driven forms of ILD.”
The Phase 1b/2a study is a multiple-ascending dose, double-blind, placebo-controlled study that is designed to evaluate the safety, tolerability, immunogenicity and pharmacokinetic profile of multiple doses of ATYR1923 compared to placebo, as well as to evaluate preliminary efficacy measures including steroid sparing effect, measures of lung function and potential disease biomarkers.
“Treatment options remain limited for pulmonary sarcoidosis, which affects around 200,000 people in the U.S. By restoring immune balance, ATYR1923 offers a potential new mechanism to resolve pathologic lung inflammation, prevent subsequent fibrosis, and improve lung function and patient outcomes in people living with pulmonary sarcoidosis with less toxicity than currently available treatments,” said Dr. Shukla.
In addition to pulmonary sarcoidosis, ATYR1923 is being evaluated in a Phase 2 trial in hospitalized COVID-19 patients with severe respiratory complications, which include an acute form of interstitial pneumonia. The company recently completed enrollment in this study and expects to report topline data in the coming weeks.