Business
aTyr Pharma Announces Fourth Quarter and Full Year 2021 Results and Provides Corporate Update
FDA End-of-Phase 2 meeting provides development pathway for efzofitimod (ATYR1923) in pulmonary sarcoidosis; planned registrational study to initiate in the
About this update from Atyr Pharma, Inc.
[{"type":"text","content":"FDA End-of-Phase 2 meeting provides development pathway for efzofitimod (ATYR1923) in pulmonary sarcoidosis; planned registrational study to initiate in the third quarter of 2022. Company ended 2021 with $107.9 million in cash, cash equivalents and investments. Company to host conference call and webcast today, March 14th, at 5:00 p.m. EDT / 2:00 p.m. PDT. SAN DIEGO, March 14, 2022 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced fourth quarter and full year 2021 results and provided a corporate update. “2021 was a milestone year for aTyr, which culminated in clinical proof-of-concept for our lead therapeutic candidate, efzofitimod (ATYR1923), and validation for our tRNA synthetase biology platform,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “The positive results reported from our Phase 1b/2a study of efzofitimod in pulmonary sarcoidosis, our initial interstitial lung disease (ILD) indication, suggest that this novel immunomodulator has the potential to be a transformative, disease modifying therapy for patients with this and other fibrotic lung diseases with high unmet need.” “We have carried this momentum into the start of 2022. The receipt of U.S. Food and Drug Administration (FDA) orphan drug designation for efzofitimod in sarcoidosis underscores the significant challenges faced by these patients. We have a path forward as a result of our positive End-of-Phase 2 meeting with the FDA and intend to initiate a planned registrational trial in pulmonary sarcoidosis in the third quarter of this year. We also remain on track with the IND-enabling work for ATYR2810, and we expect to initiate a Phase 1 study in cancer patients in the second half of this year. We ended 2021 with approximately $107.9 million in cash, and our strong balance sheet positions us well to advance our clinical programs and progress our pipeline in the year ahead.” Fourth Quarter 2021 and Subsequent Period Highlights Held a Type B End-of-Phase 2 meeting with the FDA regarding the company’s lead therapeutic candidate, efzofitimod, for the treatment of pulmonary sarcoidosis. The meeting followed positive results that the company reported from a Phase 1b/2a multiple-ascending do...