aTyr Pharma Announces Positive Phase 1 Data for ATYR1923 Therapeutic Candidate
June 26 2018 - 8:00AM
ATYR1923 Well-Tolerated at all Doses Tested, with
No Significant Adverse Events
aTyr Pharma, Inc. (Nasdaq:LIFE), a biotherapeutics company engaged
in the discovery and development of innovative medicines based on
novel immunological pathways, today announced positive data from
its Phase 1 clinical trial of ATYR1923, an immuno-modulatory
therapeutic candidate with potentially broad therapeutic
application in the treatment of interstitial lung diseases.
This first-in-human, randomized, double-blind,
placebo-controlled study was designed to investigate the safety,
tolerability, immunogenicity and pharmacokinetics of intravenous
ATYR1923 in healthy volunteers. The Phase 1 study enrolled 36
healthy volunteers who were randomized to one of six cohorts and
received a single infusion of intravenous ATYR1923 or placebo.
Doses of ATYR1923 ranged from 0.03 mg/kg up to 5.0 mg/kg. The
results indicate that the drug was generally well-tolerated at all
dose levels tested, with no significant adverse events or induction
of anti-drug antibodies observed following ATYR1923 dosing or
throughout the one-month follow-up period.
The pharmacokinetics (PK) of ATYR1923 following single-dose
administration were linear across the evaluated dose range. Higher
ATYR1923 doses yielded sustained serum concentrations through the
end of the one-month follow-up period that were above the predicted
therapeutic threshold, supporting the potential for a once-monthly
dosing regimen.
“We are encouraged by our Phase 1 safety and tolerability data,
which support the continued clinical development of ATYR1923 for
patients with inflammatory interstitial lung disease,” said Sanjay
Shukla, M.D., M.S., President and CEO of aTyr. “The PK profile of
ATYR1923 supports once monthly dosing, which we believe would be
attractive to our potential patient population. This is an
important first step in our clinical program for ATYR1923 and we
will be using this data alongside our ATYR1923 translational
research activities as we develop and initiate a patient trial in
the fourth quarter of this year.”
About aTyr
aTyr is a clinical-stage biotechnology company engaged in the
discovery and clinical development of innovative medicines using
its knowledge of tRNA synthetase biology. aTyr is focused on the
therapeutic translation of the Resokine pathway, comprised of
extracellular proteins derived from the histidyl tRNA synthetase
(HARS) gene family. aTyr’s clinical stage ATYR1923 candidate
augments the Resokine pathway and is designed to temper immune
engagement in interstitial lung diseases. aTyr’s immuno-oncology
research program targets the Resokine pathway using antibodies to
enhance the immune response in tumor settings. aTyr has built an
intellectual property estate, to protect its pipeline, comprising
over 250 issued patents or allowed patent applications that are
owned or exclusively licensed, including over 300 potential protein
compositions derived from tRNA synthetase genes. 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 Litigation Reform Act. 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, including statements
regarding the potential therapeutic benefits and applications of
our product candidates; our ability to successfully advance our
pipeline or product candidates, undertake certain development
activities (such as the initiation of clinical trials, clinical
trial enrollment, the conduct of clinical trials and the
announcement of top-line results) and accomplish certain
development goals, and the timing of such events; and the scope and
strength of our intellectual property portfolio. 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. 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, risks associated with the discovery, development and
regulation of our product candidates, the risk that we 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), 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: |
Mark Johnson |
Sr. Director, Investor
Relations |
mjohnson@atyrpharma.com |
858-223-1163 |
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