SAN DIEGO, Dec. 04, 2018 (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 the initiation of a
Phase 1b/2a study evaluating its lead candidate, ATYR1923, in patients with pulmonary sarcoidosis following acceptance of the
Company’s investigational new drug application by the US Food and Drug Administration.
aTyr also announced that it is collaborating with the Foundation for Sarcoidosis Research (FSR), the nation’s
leading nonprofit organization dedicated to finding a cure for sarcoidosis and improving care for sarcoidosis patients. Under the
terms of the collaboration, FSR will assist with clinical trial site initiation and patient enrollment. aTyr anticipates that up to
twelve sites in the United States will participate in the study. FSR’s Clinical Studies Network (FSR-CSN), which is led by a
steering committee consisting of principal investigators from leading clinical centers, has voted to support this proof-of-concept
study.
“We accomplished our previously-stated goal of initiating this proof-of-concept Phase 1b/2a study of ATYR1923
this quarter, and we look forward to data that we believe will demonstrate the first signals of clinical activity in pulmonary
sarcoidosis patients,” said Sanjay Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “As we seek to advance
ATYR1923 efficiently through clinical development, we are grateful to FSR for their support and assistance with this important
trial, and we anticipate a long and mutually beneficial partnership.”
“We are pleased to collaborate with the team at aTyr Pharma as they work to advance clinical development of a
promising new treatment for pulmonary sarcoidosis, a potentially debilitating inflammatory lung disease with no known cure,” said
Ginger Spitzer, Executive Director of FSR. “Any step supporting the study of a new therapeutic candidate is a step towards a
potential groundbreaking discovery that could improve the lives of sarcoidosis patients worldwide.”
This Phase 1b/2a study is a multiple-ascending dose, placebo-controlled, first-in-patient study of ATYR1923 that
has been designed to evaluate safety, tolerability and immunogenicity of multiple doses of ATYR1923, as well as to evaluate
established clinical endpoints and potential biomarkers to assess preliminary efficacy.
About ATYR1923
aTyr scientists successfully engineered ATYR1923, a fusion protein comprised of the immuno-modulatory domain of
histidyl tRNA synthetase (HARS) fused to the FC region of a human antibody. aTyr is developing ATYR1923 as a potential
therapeutic for patients with interstitial lung diseases. aTyr announced data from a first-in-human Phase 1 clinical trial of
ATYR1923 in June 2018. This randomized, double-blind, placebo-controlled study investigated the safety, tolerability,
immunogenicity, and pharmacokinetics (PK) of intravenous ATYR1923 in 36 healthy volunteers. The results indicate that the
drug was generally well-tolerated at all dose levels tested with no significant adverse events, and the observed PK profile
supports the potential for a once-monthly dosing regimen.
About Pulmonary Sarcoidosis
Sarcoidosis is an inflammatory disease characterized by the formation of granulomas, clumps of inflammatory
cells, in one or more organs in the body. Sarcoidosis affects people of all ages, but typically presents before the age of 50
years, with the incidence peaking at 20 to 39 years. The disorder usually begins in the lungs, skin or lymph nodes, but can
affect almost any organ. Sarcoidosis in the lungs is called pulmonary sarcoidosis and 90% or more of patients with
sarcoidosis have lung involvement. Pulmonary sarcoidosis is a major form of interstitial lung disease (ILD) a group of
immune-mediated disorders which cause progressive fibrosis of lung tissue. Estimates of prevalence vary; however, aTyr
believes that approximately 200,000 Americans live with pulmonary sarcoidosis. The prognosis for patients with pulmonary
sarcoidosis ranges from benign and self-limiting to chronic, debilitating disease with mortality.
About FSR
The Foundation for Sarcoidosis Research is the nation’s leading nonprofit organization dedicated to finding a
cure for this disease and to improving care for sarcoidosis patients. Driven by dedicated patients, scientists, caregivers and
donors, FSR’s initiatives aim to make an impact on the lives of sarcoidosis patients around the world. The FSR provides
support to fund CSN operations and carries out both core and elective studies to forward its mission of addressing unanswered
questions in the sarcoidosis space. The FSR Clinical Studies Network (FSR-CSN) is led by a Steering Committee composed of the
Principal Investigators from each participating institution. FSR-CSN is composed of 12 sites, two international and 10 U.S.-based.
For more information about FSR, visit www.stopsarcoidosis.org.
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 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. aTyr is focused on the therapeutic translation of the
Resokine pathway, comprised of extracellular proteins derived from the histidyl tRNA synthetase gene family. ATYR1923 is a
clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to down-regulate immune engagement in
interstitial lung diseases and other immune-mediated diseases. For more information, please visit http://www.atyrpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act.
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, including
statements regarding the potential therapeutic benefits and applications of our product candidates; our ability to successfully
advance our product candidates, undertake certain development activities (such as the initiation of clinical trials, clinical trial
enrollment, the conduct of clinical trials and the announcement of top-line results) and accomplish certain development goals, and
the timing of such events; and the scope and strength of our intellectual property portfolio. 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. 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, risks associated with the discovery, development and
regulation of our product candidates, the risk that we 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), 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.
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| Contact: |
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| Joyce Allaire |
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| Managing Director, LifeSci Advisors, LLC |
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| jallaire@lifesciadvisors.com |
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