aTyr Pharma, Inc., a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel immunological pathways, announced that it has dosed the first patient in a Phase 2 study evaluating its lead therapeutic candidate, ATYR1923, in COVID-19 patients with severe respiratory complications. The study is expected to enroll 30 patients at up to 10 centers in the U.S. and the company expects to have the majority of centers enrolling within the coming weeks.
ATYR1923 is a potential first-in-class immunomodulator that has been shown preclinically to downregulate T-cell responses and improve inflammation and lung function. ATYR1923 is currently being evaluated in a Phase 1b/2a multi-center trial for patients with pulmonary sarcoidosis, a serious inflammatory lung disease. There is strong scientific rationale for the hypothesis that ATYR1923 may help regulate the excessive inflammatory response in the lungs, primarily driven by T-cells, seen in many COVID-19 patients.
“As patients continue to be hospitalized due to COVID-19 throughout the U.S., there is a need for effective therapies to treat severe inflammation associated with this disease. ATYR1923 is a novel therapeutic candidate specifically designed to address aberrant immune response and inflammation in the lung,” said Dr. Sanjay Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “This is an important step forward to assess the potential utility of ATYR1923 in this subset of COVID-19 patients who experience serious respiratory complications that can lead to longer hospitalization stays and in some cases the need for mechanical ventilation and intensive care treatment.”
The Phase 2 clinical trial is a randomized, double blind, placebo-controlled study of ATYR1923 in hospitalized COVID-19 positive patients with severe respiratory complications who do not require mechanical ventilation. Patients enrolled in the trial will be assigned to one of three cohorts of 10 patients each. Patients will receive a single intravenous (IV) dose of either 1.0 or 3.0 mg/kg ATYR1923 or placebo. Patients will be followed for 60 days post treatment. The trial is designed to evaluate the preliminary safety and efficacy of ATYR1923 as compared to placebo through the assessment of key clinical outcome measures such as fever and hypoxia as well as inflammatory biomarkers.
“We are encouraged by the significant interest that we have received from respiratory specialists throughout the country wanting to participate in this trial. We have currently initiated five sites and expect the majority of sites to be active within the coming weeks. We look forward to completing this important study and report data from this trial later this year,” said Dr. Shukla.
aTyr is a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel immunological pathways. aTyr’s research and development efforts are concentrated on a newly discovered area of biology, the extracellular functionality and signaling pathways of tRNA synthetases. aTyr has built a global intellectual property estate directed to a potential pipeline of protein compositions derived from 20 tRNA synthetase genes and their extracellular targets. aTyr’s primary focus is ATYR1923, a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to down-regulate immune engagement in inflammatory lung diseases.