aTyr Pharma Announces Partner Kyorin Pharmaceutical, Co., Ltd. Proceeds to Phase 1 Trial of ATYR1923 in Japan
August 11 2020 - 7:00AM
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 DunstonInvestor
Relations and Corporate Communicationsadunston@atyrpharma.com
aTyr Pharma (NASDAQ:LIFE)
Historical Stock Chart
From Mar 2024 to Apr 2024
aTyr Pharma (NASDAQ:LIFE)
Historical Stock Chart
From Apr 2023 to Apr 2024