aTyr Pharma Announces Positive Topline Results from Phase 2 Clinical Trial of ATYR1923 in COVID-19 Patients with Severe Respi...
January 04 2021 - 4:15PM
aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged
in the discovery and development of innovative medicines based on
novel biological pathways, today announced positive topline 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 who do not require
mechanical ventilation. The trial met its primary endpoint of
safety, demonstrating that a single, intravenous (IV) dose of
ATYR1923 was generally safe and well-tolerated in both the 1.0 and
3.0 mg/kg treatment groups, with no drug-related serious adverse
events.
“We are pleased with the results of this study
which continue to demonstrate ATYR1923’s favorable safety profile
in inflammatory lung conditions,” said Sanjay S. Shukla, M.D.,
M.S., President and Chief Executive Officer of aTyr. “We are very
encouraged by the signal of clinical activity seen in the 3.0 mg/kg
cohort of ATYR1923. The relatively faster time to recovery seen by
adding a single dose of ATYR1923 to standard of care treatment and
the greater proportion of patients recovering within a week
compared to placebo give us further confidence in this signal.”
The study demonstrated a preliminary signal of
activity through clinical improvement in the high dose cohort with
the assessment of time to recovery, defined as either achieving a
WHO ordinal scale score of ≤3 or hospital discharge with no
requirement of supplemental oxygen. Patients who received the 3.0
mg/kg dose of ATYR1923 experienced a median time to recovery of 5.5
days compared to 6 days in the placebo group. In addition, 83% of
patients receiving the high dose of ATYR1923 achieved recovery by
day 6, compared to 56% in the placebo arm. Patients in the 1.0
mg/kg treatment arm experienced a median time to recovery of 7
days. All patients in the study received standard of care treatment
at the time of enrollment, which included remdesivir and/or
dexamethasone.
Adverse events were mostly mild or moderate in
severity and generally assessed as unrelated to the study drug.
This is in line with previous safety assessments of ATYR1923,
including an interim safety analysis from an ongoing Phase 1b/2a
trial in patients with pulmonary sarcoidosis, a chronic form of
interstitial lung disease. There were two deaths observed in the
study, both in the 1.0 mg/kg treatment arm, which were deemed not
related to ATYR1923 by an independent data safety monitoring
board.
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.
“Against the backdrop of the rapidly evolving
standard of care for COVID-19 patients, we have reaffirmed the
positive safety profile of ATYR1923 observed in our ongoing trial
in patients with pulmonary sarcoidosis, a chronic form of
inflammatory lung disease. We have also elucidated a signal of drug
activity from a single 3.0 mg/kg dose of ATYR9123 in this small
trial. I would like to thank the clinical sites, investigators and
patients that contributed to these important findings,” said Dr.
Shukla.
aTyr Pharma will host a conference call and
webcast to discuss the results today, January 4, at 5:00pm
ET/2:00pm PT. Interested parties may access the call by dialing
toll-free 844-358-9116 from the US, or 209-905-5951 internationally
and using conference ID 8045947. Links to a live audio webcast and
replay may be accessed on the aTyr website events page at:
http://investors.atyrpharma.com/events-and-webcasts. An audio
replay will be available for at least 90 days following the
event.
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 Dunston |
Director, Investor Relations and Corporate Communications |
adunston@atyrpharma.com |
|
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