aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel immunological pathways, today announced that its partner Kyorin Pharmaceutical Co., Ltd., or Kyorin, a wholly owned subsidiary of Kyorin Holdings, Inc., has initiated clinical development in Japan for aTyr’s lead therapeutic candidate ATYR1923 (known as KRP-R120 in Japan) following the Pharmaceutical and Medical Devices Agency (PMDA) review of its Clinical Trial Notification (CTN) submission. The CTN permits the start of clinical development activities in Japan for ATYR1923. The Phase 1 study, which will be conducted by Kyorin, will evaluate the safety, pharmacokinetics and immunogenicity of ATYR1923 in healthy male volunteers in Japan.

“We are pleased with the advance of ATYR1923 to a Phase 1 study in Japan. Fulfilling the requirement to establish pharmacokinetic data for ATYR1923 in the Japanese patient population is an important step towards expanding the clinical development of our program in ILDs globally,” said Dr. Sanjay Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “Kyorin is a committed partner with a focus on advancing new treatments for respiratory conditions. We look forward to our continued collaboration as we work to improve outcomes for patients with ILDs.”

Kyorin is aTyr’s partner for the development and commercialization of ATYR1923 for interstitial lung diseases (ILDs) in Japan. As per the agreement, aTyr previously received an $8 million upfront payment and is eligible to receive up to $167 million in the aggregate upon the achievement of certain development, regulatory and sales milestones, as well as tiered royalties on the net sales in Japan. Kyorin has the exclusive rights to commercialize ATYR1923 in Japan for ILDs.

About ATYR1923

aTyr is developing ATYR1923 as a potential therapeutic for patients with inflammatory lung diseases. ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory disease states. aTyr is currently enrolling a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis, a form of interstitial lung disease. This Phase 1b/2a study is a multi-ascending dose, placebo-controlled, first-in-patient study of ATYR1923 that has been designed to evaluate the safety, tolerability, steroid sparing effect, immunogenicity and pharmacokinetics profile of multiple doses of ATYR1923. In response to the COVID-19 pandemic, aTyr recently initiated a Phase 2 clinical trial with ATYR1923 in COVID-19 patients with severe respiratory complications. This Phase 2 study is a randomized, double blind, placebo-controlled study that has been designed to evaluate the safety and preliminary efficacy of a single dose of ATYR1923.