aTyr Pharma Announces Partner Kyorin Pharmaceutical, Co., Ltd. Doses First Subjects in Phase 1 Trial of ATYR1923 in Japan
September 15 2020 - 7:00AM
aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged
in the discovery and development of innovative medicines based on
novel biological pathways, today announced that its partner Kyorin
Pharmaceutical Co., Ltd., or Kyorin, a wholly owned subsidiary of
Kyorin Holdings, Inc., has dosed the first subjects in a Phase 1
trial of aTyr’s lead therapeutic candidate ATYR1923 (known as
KRP-R120 in Japan).
The Phase 1 trial, which is being conducted by
Kyorin, is a placebo-controlled study to evaluate the safety,
pharmacokinetics and immunogenicity of ATYR1923 in 32 healthy
Japanese male volunteers. Assuming successful completion of the
study, Kyorin would then be able to initiate patient trials in
interstitial lung diseases (ILDs) in Japan.
“ATYR1923 is a potential first-in-class
immunomodulator and may present a promising new approach to
treating ILDs,” said Dr. Sanjay Shukla, M.D., M.S., President and
Chief Executive Officer of aTyr. “To date, ATYR1923 has had a
favorable safety profile in trials conducted in the U.S. and
Australia. We look forward to the outcome of this study in a
Japanese population as we continue to advance our ILD program
globally.”
“We are pleased to initiate clinical development
of ATYR1923 in Japan by dosing the first healthy volunteers in this
study,” said Yutaka Ogihara, President and Chief Executive Officer
of Kyorin Holdings, Inc. “This trial is an important step towards
offering a potential new treatment to ILD patients in Japan.”
Kyorin is aTyr’s partner for the development and
commercialization of ATYR1923 for 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
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 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 KyorinTrusted 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 DunstonInvestor
Relations and Corporate Communicationsadunston@atyrpharma.com
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