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aTyr aTyr Pharma Announces Positive Data from Phase 1b / 2a Clinical Trial Demonstrating Consistent Dose Response for ATYR1923 in Pulmonary Sarcoidosis September 13 , 2021 Trial met primary endpoint , ATYR 1923 was safe and well - tolerated . Efficacy observed in key endpoints including steroid reduction of 58 % in the 5.0 mg / kg treatment group with 33 % of patients in the group able to taper completely off of steroids . Clinically meaningful improvements in forced vital capacity ( FVC ) of 3.3 % and all sarcoidosis symptom measures , including shortness of breath , cough , and fatigue , observed in the 5.0 mg / kg treatment group . Management to host conference call and webcast today , September 13th at 8:30 am ET / 5 : 30am PT -- SAN DIEGO , Sept. 13 , 2021 ( GLOBE NEWSWIRE ) aTyr Pharma , Inc. ( Nasdaq : LIFE ) , a clinical stage biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways , today announced positive results from its Phase 1b / 2a double - blind , placebo - controlled clinical trial of its lead therapeutic candidate , ATYR1923 , in 37 patients with pulmonary sarcoidosis , a major form of interstitial lung disease ( ILD ) . ATYR1923 was safe and well - tolerated at all doses with no drug - related serious adverse events or signal of immunogenicity . Additionally , the study demonstrated consistent dose response for ATYR1923 on key efficacy endpoints and improvements compared to placebo , including measures of steroid reduction , lung function , sarcoidosis symptom measures and inflammatory biomarkers . " We are delighted by the results of this study , which provide the first clinical proof - of - concept for ATYR1923 , as well as validation for our tRNA synthetase biology platform and Neuropilin - 2 as a target . The consistency in dose response and clinically meaningful benefit observed , along with ATYR1923's favorable safety and tolerability profile , give us great confidence that ATYR1923 could be a transformative , disease modifying therapy for pulmonary sarcoidosis patients , " said Sanjay S. Shukla , M.D. , M.S. , President and Chief Executive Officer of aTyr . " Based on the results of this study , we plan to meet with the U.S. Food and Drug Administration to present these data and our plans for subsequent clinical development and path to registration for ATYR1923 for pulmonary sarcoidosis , and we expect to initiate a registrational trial next year . " " I am very impressed by this study , which is one of the best that I have seen conducted in sarcoidosis , a patient population that is highly underserved by current treatment options , " said Robert Baughman , M.D. , Professor of Medicine and Pulmonologist at the University of Cincinnati Medical Center . " The dose response and consistent response seen across multiple efficacy measures , without added toxicity , in this patient population with advanced disease is notable . Importantly , ATYR1923 demonstrated an improvement in several indicators of quality of life , a high priority for patients , by a much larger margin than I would expect in a trial of this size and duration . " " The dose response and consistent results across almost every endpoint are remarkable findings , and as good as could be expected in this small study . The ability to taper patients off steroids while controlling disease symptoms in the ATYR1923 treatment groups is particularly compelling and supports advancement of ATYR1923 into the next phase of development , " said Daniel Culver , D.O. , Chair of the Department of Pulmonary Medicine and Director of Diffuse Parenchymal Lung Disease at The Cleveland Clinic . Key Safety and Clinical Efficacy Findings for ATYR1923 • Safe and well - tolerated at all doses • No dose - relationship with most common adverse events associated with underlying disease • No drug - related serious adverse events o No signal of immunogenicity • Dose response and consistent positive findings across key efficacy endpoints o Steroid reduction of 58 % overall from baseline and 22 % relative reduction compared to placebo in steroid usage post taper in the 5.0 mg / kg treatment group • Complete steroid taper to 0 mg achieved and maintained for 33 % of patients in the 5.0 mg / kg treatment group compared to no patients in any other group • Absolute improvement in forced vital capacity ( FVC ) as a measure of lung function at week 24 of 3.3 % in the 5.0 mg / kg treatment group compared to placebo , with an improvement in FVC of > 2.5 % considered clinically meaningful • Clinically meaningful improvement over placebo observed for dyspnea ( shortness of breath ) , cough , fatigue and the King's Sarcoidosis Scores for Lung and General Health in 5.0 mg / kg treatment group o Dose dependent trends of improvement in key inflammatory biomarkers compared to placebo including IL - 6 , MCP - 1 , IFN - Y , IP - 10 and TNFa as well as key sarcoidosis markers including ACE , IL - 2Ra and SAA with tightest control in the 5.0 mg / kg treatment group • FDG - PET - CT was not evaluable due to incomplete data primarily caused by operational issues related to the COVID - 19 pandemic Phase 1b / 2a Clinical Trial in Patients with Pulmonary Sarcoidosis