Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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/kg is an investigational small molecule being developed for respiratory conditions, including pulmonary sarcoidosis, interstitial lung disease, and severe pneumonia related to SARS-CoV-2 (COVID-19). It is administered intravenously and is currently in clinical trials, with the most advanced study being a Phase 3 trial in pulmonary sarcoidosis.
Efzofitimod/kg is 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/kg is in Phase 3 clinical development for pulmonary sarcoidosis, based on a completed Phase 3 trial (NCT05415137). It is also being studied in Phase 2 trials for COVID-19 severe pneumonia and interstitial lung disease. The drug is investigational and not yet approved by regulatory authorities.
Efzofitimod/kg has been evaluated in three clinical trials. NCT04412668 was a completed Phase 2 study in COVID-19 severe pneumonia. NCT05415137 was a completed Phase 3 trial in pulmonary sarcoidosis. NCT05892614 is an ongoing Phase 2 trial in systemic sclerosis-related interstitial lung disease.
Yes, Efzofitimod/kg is also known as efzofitimod, and the drug is sometimes referred to by the dose strength efzofitimod 450 mg. These names refer to the same investigational compound developed by aTyr Pharma.
Efzofitimod/kg is not FDA approved. It remains an investigational drug in clinical development, with trials ongoing or completed in pulmonary sarcoidosis, interstitial lung disease, and COVID-19 severe pneumonia. Approval status has not been granted for any indication.