aTyr Pharma Announces Completion of Enrollment in Phase 1b/2a Clinical Trial of ATYR1923 in Patients with Pulmonary Sarcoidos...
December 21 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 it has completed
the target enrollment in its Phase 1b/2a clinical trial of its lead
therapeutic candidate, ATYR1923, in patients with pulmonary
sarcoidosis, a form of interstitial lung disease (ILD). The study
enrolled 36 patients.
The company expects to report data from this
trial in the third quarter of 2021. Results of this study will
inform future development for ATYR1923 in ILD, which may include a
registrational trial in pulmonary sarcoidosis and expansion into
trials for other forms of ILD.
“We are pleased to meet the target enrollment of
this important study, especially during the COVID-19 pandemic.
Reaching this significant milestone for our ATYR1923 clinical
program and the interest we’ve seen from patients to join the trial
highlights the need for new therapies for this chronic,
debilitating disease,” said Sanjay S. Shukla, M.D., M.S., President
and Chief Executive Officer of aTyr. “We look forward to sharing
the results in the third quarter of next year, which will provide
meaningful insights into ATYR1923’s therapeutic potential in
patients with pulmonary sarcoidosis and other major immune-driven
forms of ILD.”
The Phase 1b/2a study is a multiple-ascending
dose, double-blind, placebo-controlled study that is designed to
evaluate the safety, tolerability, immunogenicity and
pharmacokinetic profile of multiple doses of ATYR1923 compared to
placebo, as well as to evaluate preliminary efficacy measures
including steroid sparing effect, measures of lung function and
potential disease biomarkers.
“Treatment options remain limited for pulmonary
sarcoidosis, which affects around 200,000 people in the U.S. By
restoring immune balance, ATYR1923 offers a potential new mechanism
to resolve pathologic lung inflammation, prevent subsequent
fibrosis, and improve lung function and patient outcomes in people
living with pulmonary sarcoidosis with less toxicity than currently
available treatments,” said Dr. Shukla.
In addition to pulmonary sarcoidosis, ATYR1923
is being evaluated in a Phase 2 trial in hospitalized COVID-19
patients with severe respiratory complications, which include an
acute form of interstitial pneumonia. The company recently
completed enrollment in this study and expects to report topline
data in the coming weeks.
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
initiated and completed enrollment in 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 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: |
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Ashlee Dunston |
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Director, Investor Relations and
Corporate Communications |
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adunston@atyrpharma.com |
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