aTyr Pharma Announces Completion of Enrollment in Phase 2 Clinical Trial of ATYR1923 in COVID-19 Patients with Severe Respira...
October 26 2020 - 07:00AM
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 it has completed
enrollment in its Phase 2 clinical trial of its lead therapeutic
candidate, ATYR1923, in COVID-19 patients with severe respiratory
complications. The study enrolled a total of 32 patients at
hospitals in the U.S. and Puerto Rico, exceeding the target
enrollment of 30 patients. The company expects to report topline
data from this trial by the end of this year.
“We are pleased to have completed the full
enrollment of this study, which is an important step forward in our
effort to aid in the fight against the global COVID-19 pandemic,”
said Sanjay S. Shukla, M.D., M.S., President and Chief Executive
Officer of aTyr. “Throughout the course of this year, we have
continued to advance our knowledge of the disease pathology of
COVID-19, which in many patients includes a form of interstitial
pneumonia that causes severe respiratory complications which can
lead to long-term lung damage. We believe ATYR1923 leverages newly
discovered biological pathways to down-regulate excessive
inflammatory responses which may restore immune balance in the
lung, offering the potential of a differentiated approach to treat
this subset of patients with severe lung inflammation for which
there are limited available treatment options. We look forward to
sharing topline results of this study later this year.”
The Phase 2 clinical trial is a randomized,
double blind, placebo-controlled study of ATYR1923 in hospitalized
COVID-19 patients with severe respiratory complications who do not
require mechanical ventilation. Patients enrolled in the trial were
randomized 1:1:1 to a single intravenous dose of either 1.0 or 3.0
mg/kg of ATYR1923 or placebo. Patients are followed for 60 days
post treatment. The trial is designed to evaluate the preliminary
safety and efficacy of ATYR1923 as compared to placebo through the
assessment of key clinical outcome measures.
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 is
conducting 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.
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 timing of data from
clinical trials) 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
completing clinical trials or negative data from preclinical
studies or 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.
Contact: |
Ashlee Dunston |
Investor Relations, aTyr
Pharma |
adunston@atyrpharma.com |
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