- The stock price of aTyr Pharma Inc (NASDAQ: LIFE) significantly increased today. This is why it happened.
The stock price of aTyr Pharma Inc (NASDAQ: LIFE) – a clinical-stage biotherapeutics company engaged in the discovery and development of medicines based on novel biological pathways – significantly increased today. Investors are responding positively to aTyr Pharma and its Hong Kong subsidiary Pangu BioPharma Limited (Pangu) — which supports basic and translational research in tRNA synthetase biology in collaboration with the Hong Kong University of Science and Technology (HKUST) — announcing today positive results from the company’s Phase 1b/2a double-blind, placebo-controlled clinical trial of its lead therapeutic candidate ATYR1923, in 37 patients with pulmonary sarcoidosis, a major form of interstitial lung disease (ILD). ATYR1923 was safe and well-tolerated at all doses with no drug-related serious adverse events or signal of immunogenicity. Additionally, the study demonstrated consistent dose-response for ATYR1923 on key efficacy endpoints and improvements compared to placebo, including measures of steroid reduction, lung function, sarcoidosis symptom measures and inflammatory biomarkers.
The researchers from Pangu and HKUST were instrumental in discovering a splice variant of histidyl-tRNA synthetase (HARS) that liberates a smaller and extracellular signaling domain from the full-length tRNA synthetase shown to modulate the immune system. And ATYR1923 is a fusion protein comprised of this domain fused to the FC region of a human antibody.
Based on the results of the study, aTyr Pharma plans to meet with the U.S. Food and Drug Administration to present these data and plans for subsequent clinical development and path to registration for ATYR1923 for pulmonary sarcoidosis and expects to initiate a registrational trial next year.
Phase 1b/2a Clinical Trial in Patients with Pulmonary Sarcoidosis
The Phase 1b/2a study was a randomized, double-blind, placebo-controlled, and multiple-ascending dose clinical trial in 37 patients with pulmonary sarcoidosis. And the trial consisted of three cohorts testing doses of 1.0 mg/kg, 3.0 mg/kg and 5.0 mg/kg of ATYR1923 or placebo, dosed intravenously every month for 6 months.
The primary objective of the study was for evaluating the safety, tolerability, immunogenicity and pharmacokinetic profile of multiple doses of ATYR1923 compared to placebo. And secondary objectives included the potential steroid-sparing effects of ATYR1923, in addition to other exploratory assessments of efficacy.
“We are very pleased to be a part of this groundbreaking work for ATYR1923, which represents the first clinical proof-of-concept for a tRNA synthetase derived therapy. The consistent dose response and clinically meaningful benefit observed across key efficacy endpoints is quite notable. The formative basic research leading to the discovery of the active extracellular signaling domain of HARS conducted by Pangu and HKUST laid the foundation for the development of ATYR1923. We look forward to the next steps for the ATYR1923 clinical program and the potential of this novel therapeutic to improve patient outcomes in patients with pulmonary sarcoidosis.”
— Paul Schimmel, Ph.D., Professor of Molecular Medicine at The Scripps Research Institute and Founder of aTyr and Pangu
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