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Also known as efzofitimod
Efzofitimod /kg · 2 trials · 2 indications
TEAEs were defined as adverse events (AEs) with an onset following administration of the first dose of study drug. AEs were defined as any untoward medical occurrence in a participant administered study drug and that does not necessarily have a causal relationship with the study drug. Worsening of a pre-existing medical condition should have been considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. SAEs were defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section.
| Arm | Type | Description |
|---|---|---|
| Efzofitimod 3 mg/kg | EXPERIMENTAL | - |
| Efzofitimod 5 mg/kg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Efzofitimod 1 mg/kg | EXPERIMENTAL | Participants will receive single dose of efzofitimod 1 milligrams/kilograms (mg/kg) IV infusion on Day 1. |
| Name | Type | Description |
|---|---|---|
| Efzofitimod 3 mg/kg | DRUG | Efzofitimod IV infusion every 4 weeks for a total of 12 doses |
| Efzofitimod 5 mg/kg | DRUG | Efzofitimod IV infusion every 4 weeks for a total of 12 doses |
| Placebo | DRUG | Placebo IV infusion every 4 weeks for a total of 12 doses |
| Efzofitimod 1 mg/kg | DRUG | Concentrate for solution for infusion |
Inclusion Criteria: * Documented history of pulmonary sarcoidosis for at least 6 months, supported by the following evidence: documented histologically proven diagnosis of sarcoidosis by tissue biopsy and documented evidence of parenchymal lung involvement by historical radiological evidence * Evid...
Efzofitimod is an investigational small molecule being developed for pulmonary sarcoidosis, SARS-CoV-2 (COVID-19) severe pneumonia, and interstitial lung disease. It is currently in Phase 3 clinical development for pulmonary sarcoidosis, with additional studies in other respiratory conditions.
Efzofitimod is being developed by aTyr Pharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ATYR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple respiratory indications.
Efzofitimod is in Phase 3 clinical development for pulmonary sarcoidosis. A Phase 3 trial has been completed, and additional Phase 2 studies have been conducted or are ongoing for other indications, including COVID-19 severe pneumonia and interstitial lung disease.
Efzofitimod has been studied in three clinical trials. NCT04412668 was a completed Phase 2 trial in COVID-19 severe pneumonia. NCT05415137 was a completed Phase 3 trial in pulmonary sarcoidosis. NCT05892614 is a recruiting Phase 2 trial in systemic sclerosis-related interstitial lung disease.
Efzofitimod is also known as ATYR1923. The Phase 2 trial in COVID-19 severe pneumonia, NCT04412668, was titled 'Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19', confirming that both names refer to the same drug.
In the Phase 3 trial for pulmonary sarcoidosis, efzofitimod was administered intravenously. The trial was randomized, double-blind, and placebo-controlled, enrolling 268 participants across multiple countries including the United States, Brazil, France, Germany, Italy, Japan, Netherlands, Spain, and the United Kingdom.