LIFE - aTyr Pharma to begin registrational trial for lead asset in Q3 2022

After a meeting with the U.S. Food and Drug Administration (FDA), the clinical-stage biotech aTyr Pharma (NASDAQ:LIFE) announced on Thursday that the company expected to initiate a registrational study for its lead candidate efzofitimod in Q3 2022 targeting patients with pulmonary sarcoidosis. The decision follows the FDA’s review of the data package for efzofitimod (ATYR1923) that included its early clinical trial data, as well as the results from the recently completed Phase 1b/2a study. At the so-called Type B End-of-Phase 2 meeting, the regulator had advised the company to subject multiple doses of efzofitimod in a longer duration study to create a “controlled safety database” for the selection of the optimal dose for long-term use of the drug. Early this year, aTyr (LIFE) announced that the FDA granted its Orphan Drug Designation for the therapy in sarcoidosis, an inflammatory condition that mostly affects the lungs.

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aTyr Pharma to begin registrational trial for lead asset in Q3 2022