Ongoing Clinical Trials
ATYR1923-C-002: Investigational Trial of ATYR1923 for the Treatment of Pulmonary Sarcoidosis
We are currently enrolling 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 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 will also 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.
We are looking for adults, 18 to 70 years of age, who have been diagnosed with pulmonary sarcoidosis for at least 6 months, and are currently taking a stable regimen of 10 to 25 mg/day of prednisone, or similar medication.
Patients who are eligible for the study will receive a dose of study drug (placebo or ATYR1923) once every 4 weeks intravenously (through an IV) for approximately 5 months (a total of 6 doses). The study drug dose received will depend on which study group the participant belongs.
Please note that if you qualify and are selected for the study you must be able to visit the study site every 2 weeks for the first month and then at least every four weeks for a 6-month period.
Study drug and required examinations and procedures during the study are at no cost to patients. Travel reimbursement for the initial screening and all study visits is also available.
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. FSR will assist with clinical trial site initiation and patient enrollment.
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.