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ATyr Pharma Announces Achievement of Development Milestone by Partner Kyorin Pharmaceutical, Co., Ltd.

Tuesday, February 07, 2023

aTyr Pharma, Inc., a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that its partner Kyorin Pharmaceutical Co., Ltd. (Kyorin), a wholly owned subsidiary of Kyorin Holdings, Inc., has dosed the first patient in Japan in EFZO-FIT™, a global pivotal Phase 3 study to evaluate the efficacy and safety of the Company’s lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis, a major form of interstitial lung disease (ILD). This achievement has triggered a $10 million milestone payment by Kyorin to aTyr pursuant to a collaboration and license agreement between the Company and Kyorin.

Efzofitimod is a first-in-class immunomodulator that downregulates innate and adaptive immune responses in uncontrolled inflammatory diseases states via selective modulation of neuropilin-2 (NRP2). The design of the EFZO-FIT™ study is supported by safety and efficacy data from a Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis. Efzofitimod has been granted U.S. Food and Drug Administration (FDA) and E.U. orphan drug and FDA Fast Track designations for sarcoidosis.

“We are very pleased with Kyorin’s timely start to EFZO-FIT™ and are happy to have centers open for enrollment in Japan, which is an important part of this large, global study,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “Kyorin is responsible for the clinical development of efzofitimod for ILD in Japan and is an essential partner for aTyr as we work to bring this transformative, disease modifying therapy to sarcoidosis patients.”

“This study is an important step towards offering a potential new treatment to ILD patients who are with limited medical treatment options in Japan; therefore, the initiation of this study is of much value to Kyorin,” said Yutaka Ogihara, President and Chief Executive Officer of Kyorin Holdings, Inc.

Kyorin is aTyr’s partner for the development and commercialization of efzofitimod for ILD in Japan. Under the collaboration and license agreement with Kyorin, aTyr has generated $20 million in upfront and milestone payments to date and is eligible to receive up to an additional $155 million in the aggregate upon the achievement of certain development, regulatory and sales milestones, as well as tiered royalties on any net sales in Japan. Kyorin has the exclusive rights to develop and commercialize efzofitimod in Japan for all forms of ILD.

The EFZO-FIT™ study is a global Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously once a month for a total of 12 doses. The study intends to enroll 264 subjects with pulmonary sarcoidosis at multiple centers in the United States, Europe and Japan. The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction. Secondary endpoints include measures of lung function and sarcoidosis symptoms.

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