aTyr Pharma Announces Partner Kyorin Pharmaceutical, Co., Ltd. Proceeds to Phase 1 Trial of ATYR1923 in Japan

Rhea-AI Summary

aTyr Pharma has announced that its partner, Kyorin Pharmaceutical, has initiated clinical development for ATYR1923 in Japan after receiving approval from the PMDA. The Phase 1 study will focus on safety, pharmacokinetics, and immunogenicity in healthy volunteers. aTyr received an $8 million upfront payment and could earn up to $167 million in milestone payments, along with tiered royalties on sales in Japan. aTyr is also enrolling a Phase 1b/2a trial for pulmonary sarcoidosis and a Phase 2 trial for COVID-19 patients experiencing severe respiratory issues.

Positive

• Initiation of Phase 1 study for ATYR1923 in Japan, expanding market potential.
• Received $8 million upfront payment from Kyorin, with additional potential earnings of up to $167 million.
• Ongoing clinical trials for ATYR1923 in pulmonary sarcoidosis and COVID-19, indicating continued product development.

Negative

• None.

SAN DIEGO, Aug. 11, 2020 (GLOBE NEWSWIRE) -- 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.

About aTyr

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. For more information, please visit http://www.atyrpharma.com.

About Kyorin

Trusted among patients and professionals in the medical industry, Kyorin Pharmaceutical Co., Ltd. strives to be a company that contributes to public health and is recognized as one with social significance by improving its presence in specific therapeutic areas and through global discovery of novel drugs. Kyorin Pharmaceutical Co., Ltd. uses a franchise customer strategy where its marketing efforts are focused on respiratory, otolaryngology and urology. In drug discovery, it is deploying 'selection and concentration' and promoting activities aimed at first-in-class drug discovery, such as actively searching for and introducing external drug discovery themes as well as multi-tiered program development. For more information, please visit http://www.kyorin-pharm.co.jp.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include statements regarding the potential therapeutic benefits and applications of ATYR1923; timelines and plans with respect to certain development activities (such as the scope and timelines of clinical trials), potential benefits of collaborations and certain development goals. These forward-looking statements also reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects, as reflected in or suggested by these forward-looking statements, are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. Furthermore, actual results may differ materially from those described in these forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, uncertainty regarding the COVID-19 pandemic, risks associated with the discovery, development and regulation of our product candidates, the risk that we or our partners may cease or delay preclinical or clinical development activities for any of our existing or future product candidates for a variety of reasons (including difficulties or delays in patient enrollment in planned clinical trials), the possibility that existing collaborations could be terminated early, and the risk that we may not be able to raise the additional funding required for our business and product development plans, as well as those risks set forth in our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:
Ashlee Dunston
Investor Relations and Corporate Communications
adunston@atyrpharma.com

FAQ

What is the purpose of the Phase 1 study for ATYR1923 in Japan?

The Phase 1 study aims to evaluate the safety, pharmacokinetics, and immunogenicity of ATYR1923 in healthy male volunteers.

What are the financial implications of the partnership with Kyorin for aTyr Pharma?

aTyr received an $8 million upfront payment and could earn up to $167 million in milestone payments and tiered royalties on sales in Japan.

What other trials is aTyr Pharma conducting for ATYR1923?

aTyr is enrolling a Phase 1b/2a trial for ATYR1923 in pulmonary sarcoidosis and has initiated a Phase 2 trial for COVID-19 patients with severe respiratory complications.

How does ATYR1923 work in treating inflammatory lung diseases?

ATYR1923 is designed to downregulate immune engagement in inflammatory lung diseases by modulating neuropilin-2.