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aTyr Pharma Announces Positive End-of-Phase 2 Meeting with FDA on Efzofitimod for the Treatment of Pulmonary Sarcoidosis
Regulatory path forward supports company’s intention to initiate a planned registrational study in the third quarter of 2022. SAN DIEGO, March 10, 2022 (GLOBE
About this update from Atyr Pharma, Inc.
[{"type":"text","content":"Regulatory path forward supports company’s intention to initiate a planned registrational study in the third quarter of 2022.\nSAN DIEGO, March 10, 2022 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (aTyr or the “Company”), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced the positive outcome of a Type B End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding its lead therapeutic candidate, efzofitimod (ATYR1923), for the treatment of pulmonary sarcoidosis. As a result, the Company intends to initiate a planned registrational study of efzofitimod in the third quarter of 2022. “We are pleased with the very productive feedback we received from the FDA, in particular, the emphasis around the steroid-sparing effects of efzofitimod. As the most advanced clinical development program for pulmonary sarcoidosis, we have an opportunity to establish efficacy endpoints that, if successful in demonstrating clinically meaningful treatment effects, will serve as a basis for future FDA review,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “This is an important milestone for aTyr, and we now have a path forward to initiate a planned registrational study of efzofitimod that will incorporate the feedback we received from the FDA. Preparations for the study are underway, and we are on track to initiate this study in the third quarter of this year.” Following the FDA’s review of the data package, including data from the nonclinical program, early clinical trials and the recently completed Phase 1b/2a study, the Company will proceed with the advancement of efzofitimod. The FDA discussed endpoints detailed by the Company in its proposed registrational study and prioritization of outcome measurements that would best support the evaluation of efzofitimod’s efficacy. The FDA advised the continued evaluation of multiple doses of efzofitimod in a longer duration study to establish a controlled safety database that supports the determination of the optimal dose for chronic use. “As an attendee of the meeting, I came away impressed that the FDA appreciated the need for a therapeutic that demonstrates a steroid-sparing effect. This is an important step forward, as the well-recognized complications ...