Clinical Trials

Ongoing Clinical Trials

ATYR1923-C-002: Investigational Trial of ATYR1923 for the Treatment of Pulmonary Sarcoidosis

We are conducting a Phase 1b/2a clinical trial evaluating an investigational medicine, ATYR1923, in patients with pulmonary sarcoidosis.

Pulmonary sarcoidosis is an inflammatory disease of unknown cause, characterized by the formation of granulomas, clumps of inflammatory cells, in the lungs. If left untreated, this inflammation can lead to lung damage. ATYR1923 works by dampening immune responses in inflammatory disease states. ATYR1923’s effect on immune cells potentially overlaps with the cellular pathology observed in pulmonary sarcoidosis.

The Phase 1b/2a trial is a multiple-ascending dose, double-blind, placebo-controlled study evaluating ATYR1923 in 36 patients with pulmonary sarcoidosis. The purpose of this study is to determine if ATYR1923 is safe and tolerable in patients with pulmonary sarcoidosis who are undergoing a protocol-guided oral corticosteroid taper. This study is also designed to explore whether ATYR1923 has the potential to reduce oral corticosteroid use, as well as the effects ATYR1923 may have on pulmonary sarcoidosis by lung imaging, pulmonary function tests, health-related quality of life assessments and biomarkers.

aTyr is collaborating with the Foundation for Sarcoidosis Research (FSR), the nation’s leading nonprofit organization dedicated to finding a cure for sarcoidosis and improving care for sarcoidosis patients.

We recently completed enrollment in this study. For more information, please visit clinicaltrials.gov (NCT03824392).

ATYR1923-C-003: Investigational Trial of ATYR1923 for the Treatment of COVID-19 Related Severe Respiratory Complications

We are conducting a Phase 2 clinical trial evaluating ATYR1923 in patients with COVID-19 related severe respiratory complications. The trial is a randomized, double blind, placebo-controlled study designed to investigate the safety and preliminary efficacy of ATYR1923 in 32 confirmed COVID-19 positive patients who are hospitalized and do not require mechanical ventilation. Patients enrolled in the trial are randomized 1:1:1 to receive a single intravenous dose of either 1.0 or 3.0 mg/kg ATYR1923 or placebo.

We recently completed enrollment in this study. For more information, please visit clinicaltrials.gov (NCT04412668).

Completed Clinical Trials

ATYR1923 HEALTHY SUBJECTS SINGLE ASCENDING DOSE TRIAL: PHASE 1

In the second quarter of 2018 we announced positive data from our Phase 1 clinical trial of ATYR1923. This first-in-human, randomized, double-blind, placebo-controlled study was designed to investigate the safety, tolerability, immunogenicity and pharmacokinetics of intravenous ATYR1923 in healthy volunteers. The Phase 1 study enrolled 36 healthy volunteers who were randomized to one of six cohorts and received a single infusion of intravenous ATYR1923 or placebo. Doses of ATYR1923 ranged from 0.03 mg/kg up to 5.0 mg/kg. The results indicate that the drug was generally well-tolerated at all dose levels tested, with no significant adverse events or induction of anti-drug antibodies observed following ATYR1923 dosing or throughout the one-month follow-up period.

The pharmacokinetics (PK) of ATYR1923 following single-dose administration were linear across the evaluated dose range. Higher ATYR1923 doses yielded sustained serum concentrations through the end of the one-month follow-up period that were above the predicted therapeutic threshold, supporting the potential for a once-monthly dosing regimen. 


Anzctr.org.au
 
Data Release

 

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