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Also known as efzofitimod
Efzofitimod/kg · 3 trials · 3 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 450 mg | EXPERIMENTAL | Administered IV infusion |
| efzofitimod 270 mg | EXPERIMENTAL | Administered IV infusion |
| 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 450 mg | DRUG | IV infusion over approximately 60 minutes every 4 weeks |
| efzofitimod 270 mg | DRUG | IV infusion over approximately 60 minutes every 4 weeks |
| 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 therapy being studied for interstitial lung disease, pulmonary sarcoidosis, and severe pneumonia related to COVID-19. It is being developed by aTyr Pharma, Inc. (ticker ATYR) and is designed to address inflammatory lung conditions. The drug has been tested in clinical trials across these respiratory indications.
Efzofitimod is in Phase 2 development for interstitial lung disease, with a Phase 2 trial also completed in severe COVID-19 pneumonia. A Phase 3 trial in pulmonary sarcoidosis has been completed. The drug is investigational and has not been approved by the FDA for any indication.
Efzofitimod is being developed by aTyr Pharma, Inc., which trades under the ticker ATYR. The company is responsible for the clinical development program across interstitial lung disease, pulmonary sarcoidosis, and severe COVID-19 pneumonia.
Efzofitimod has been studied in three registered trials. NCT05892614 is a recruiting Phase 2 study in systemic sclerosis-related interstitial lung disease. NCT05415137 is a completed Phase 3 trial in pulmonary sarcoidosis with 268 participants. NCT04412668 is a completed Phase 2 trial in severe COVID-19 pneumonia.
Yes, efzofitimod was previously known as ATYR1923. It is also referred to by dose-specific names including efzofitimod 1 mg/kg, efzofitimod 3 mg/kg, and efzofitimod 450 mg. All of these names refer to the same investigational compound developed by aTyr Pharma.
Efzofitimod is being evaluated as a treatment for pulmonary sarcoidosis, a inflammatory lung condition. A Phase 3 trial, NCT05415137, has been completed in this indication with 268 participants across the United States, Brazil, France, Germany, Italy, Japan, the Netherlands, Spain, and the United Kingdom.