aTyr Pharma Announces Positive Biomarker Data from Phase 2 Clinical Trial of ATYR1923 Demonstrating Anti-Inflammatory Effects...
March 15 2021 - 8:00AM
aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged
in the discovery and development of innovative medicines based on
novel biological pathways, today announced biomarker results from
its Phase 2 double-blind, placebo-controlled clinical trial of its
lead therapeutic candidate, ATYR1923, in hospitalized COVID-19
patients with severe respiratory complications receiving standard
of care, including remdesivir and/or dexamethasone, who did not
require mechanical ventilation. Patients treated with ATYR1923
demonstrated a trend of overall improvement in key biomarkers
analyzed compared to placebo. In particular, patients treated with
ATYR1923 had greater reduction in levels of several inflammatory
cytokines and chemokines, including interferon gamma (IFNγ),
interleukin-6 (IL-6) and monocyte chemoattractant protein 1(MCP-1).
Furthermore, patients treated with ATYR1923 also had a
statistically significant reduction in levels of serum amyloid A
(SAA), a marker of inflammation and fibrosis that has implications
in sarcoidosis.
“We are very pleased with these findings, which
provide the first mechanistic proof-of-concept for ATYR1923 in
patients and demonstrate that ATYR1923 is impacting inflammation in
patients consistent with what we have seen preclinically,” said
Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer
of aTyr. “Notably, the cytokines that we saw reduced to the
greatest extent as a result of ATYR1923 treatment in these COVID-19
patients are the same cytokines we have seen ATYR1923 downregulate
in our animal models. We also saw an impact on SAA, a biomarker
that is associated with disease progression in sarcoidosis, a
highly inflammatory form of interstitial lung disease (ILD) and the
lead indication in which ATYR1923 is being evaluated. These
findings further support our understanding of ATYR1923’s
anti-inflammatory mechanism of action.”
The biomarker results build upon the positive
topline data the company released demonstrating that ATYR1923 met
its primary safety endpoint and improved median time to recovery to
5.5 days in patients receiving a single dose of 3.0 mg/kg ATYR1923
vs 6 days in the placebo group. Demographic and baseline disease
characteristics data included in the topline results showed that
the ATYR1923 treatment groups had more patients over the age of 65,
with severe hypoxia or with multiple comorbidities compared to
placebo, factors associated with a greater risk of COVID-19
complications and worse outcomes. Biomarker data confirms that at
baseline, patients enrolled in the ATYR1923 treatment arms compared
to placebo had higher levels of inflammatory cytokines and known
COVID-19 biomarkers including ferritin, D-dimer and C-reactive
protein (CRP), indicating a more inflamed patient population in the
ATYR1923 treatment arms.
“While this was a small study, overall trends
showing a reduction of these biomarkers combined with the higher
baseline levels in the ATYR1923 treatment groups suggest that we
have drug activity and ATYR1923 appears to provide an added
anti-inflammatory benefit even when given concomitantly with
steroids. These findings further demonstrate the potential of
ATYR1923 as a therapeutic for severe inflammatory lung disease,
including pulmonary sarcoidosis and other ILD,” said Dr.
Shukla.
The Phase 2 clinical trial was a randomized,
double blind, placebo-controlled study of ATYR1923 in 32
hospitalized COVID-19 patients with severe respiratory
complications, who did not require mechanical ventilation, at
hospitals in the U.S. and Puerto Rico. Patients enrolled in the
trial were randomized 1:1:1 to a single IV dose of either 1.0 or
3.0 mg/kg of ATYR1923 or placebo. Patients were followed for 60
days post treatment. The study was not powered for statistical
significance and was designed to evaluate safety and identify
preliminary signs of activity of ATYR1923 as compared to
placebo.
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 recently completed enrollment in
a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in
patients with pulmonary sarcoidosis. 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
pharmacokinetic profile of multiple doses of ATYR1923. In response
to the COVID-19 pandemic, aTyr completed a Phase 2 clinical trial
with ATYR1923 in COVID-19 patients with severe respiratory
complications. This Phase 2 study was a randomized, double blind,
placebo-controlled study that was 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 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:Ashlee DunstonDirector,
Investor Relations and Corporate
Communicationsadunston@atyrpharma.com
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