Results from Phase 1b/2a study of efzofitimod in pulmonary sarcoidosis patients demonstrate safety and dose dependent trends of improvement compared to placebo for key efficacy endpoints.

Efzofitimod treatment reduces pro-inflammatory serum biomarkers in pulmonary sarcoidosis patients.

Ex-vivo stimulation of PBMCs from pulmonary sarcoidosis patients treated with efzofitimod show reduced inflammatory responses.

SAN DIEGO, April 01, 2022 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (aTyr or the “Company”), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced that the company will present clinical and preclinical data for efzofitimod (ATYR1923), its lead therapeutic candidate, in three posters at the American Thoracic Society (ATS) 2022 International Conference, which is being held May 13 – 18, 2022, in San Francisco, CA.

“The selection of three abstracts featuring data for efzofitimod highlight the potential of this novel immunomodulator to be a disease modifying, transformative therapy for patients with pulmonary sarcoidosis,” said Sanjay S. Shukla, M.D., M.S., President and CEO of aTyr. “Notably, we look forward to presenting additional clinical and biomarker data from the recently completed Phase 1b/2a study, which demonstrate efzofitimod’s anti-inflammatory effects and dose dependent trends of improvement compared to placebo for key efficacy endpoints. We intend to advance efzofitimod to a planned registrational study, which we expect to initiate in the third quarter of this year.”

Details of the poster presentations appear below. The corresponding abstracts are now available for review online on the conference website. The posters will be available on the aTyr website once presented.

Title: Safety and Efficacy ATYR1923, a Novel Immunomodulator for Pulmonary Sarcoidosis: Results of a Phase 1b/2a Randomized Placebo-Controlled Trial
Abstract Number: 3932
Poster Number: P559
Poster Session: Inflammatory Modulation in Sarcoidosis, Lung Transplant, and Other
Date and Time: Tuesday, May 17, 2022 from 11:15AM – 1:15PM PT
Location: Area G, Hall F (North Building, Exhibition Level), Moscone Center

Title: ATYR1923 Treatment Reduces Pro-Inflammatory Serum Biomarkers in Pulmonary Sarcoidosis Patients
Abstract Number: 3933
Poster Number: P560
Poster Session: Inflammatory Modulation in Sarcoidosis, Lung Transplant, and Other
Date and Time: Tuesday, May 17, 2022 from 11:15AM – 1:15PM PT
Location: Area G, Hall F (North Building, Exhibition Level), Moscone Center

Title: Ex Vivo Stimulation of PBMCs from Pulmonary Sarcoidosis Patients Treated with ATYR1923 Show Reduced Inflammatory Responses
Abstract Number: 3938
Poster Number: P565
Poster Session: Inflammatory Modulation in Sarcoidosis, Lung Transplant, and Other
Date and Time: Tuesday, May 17, 2022 from 11:15AM – 1:15PM PT
Location: Area G, Hall F (North Building, Exhibition Level), Moscone Center

About Efzofitimod

aTyr is developing efzofitimod as a potential therapeutic for patients with fibrotic lung disease. Efzofitimod, 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 innate and adaptive immune response in inflammatory disease states. aTyr’s lead indication for efzofitimod is pulmonary sarcoidosis, a major form of interstitial lung disease. Clinical proof-of-concept for efzofitimod was recently established in a Phase 1b/2a multiple-ascending dose, placebo-controlled study of efzofitimod in patients with pulmonary sarcoidosis, which demonstrated safety and a consistent dose response and trends of benefit of efzofitimod compared to placebo on key efficacy endpoints, including steroid reduction, lung function, clinical symptoms and inflammatory biomarkers. aTyr intends to initiate a planned registrational study of efzofitimod in pulmonary sarcoidosis in the third quarter of 2022.     

About aTyr

aTyr is a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological 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 efzofitimod, a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to downregulate immune engagement in fibrotic lung disease. For more information, please visit www.atyrpharma.com.

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 potential therapeutic benefits and applications of efzofitimod; timelines and plans with respect to certain development activities (such as the timing and design of additional clinical trials and planned interactions with regulatory authorities); 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.

Source: aTyr Pharma, Inc.