– Second Physiocrine-based therapeutic
candidate enters the clinic –
aTyr Pharma, Inc. (Nasdaq:LIFE), a biotherapeutics company engaged
in the discovery and development of immuno-modulatory protein
therapeutics to treat patients suffering from rare, severe,
immune-mediated diseases, as well as various cancers, today
announced that it has dosed the first subjects in a Phase 1 trial
of iMod.Fc (ATYR1923), aTyr's first engineered Physiocrine and
second therapeutic candidate, in development for the treatment of
interstitial lung diseases (ILDs).
"The initiation of this study of iMod.Fc represents a
significant milestone in the advancement of our programs and marks
the second therapeutic candidate leveraging our understanding of
the Resokine pathway to enter the clinic," said Sanjay Shukla,
M.D., M.S., President and CEO of aTyr Pharma. "We look forward to
announcing top-line results from this study in the second quarter
of 2018, which we will use to guide our future development plans
for iMod.Fc as we explore the potential of the Resokine pathway in
restoring tissue homeostasis in patients with interstitial lung
disease.”
This first-in-human, randomized, double-blind,
placebo-controlled study is designed to investigate the safety,
tolerability, immunogenicity, pharmacokinetics and pharmacodynamics
of intravenous iMod.Fc (ATYR1923) in healthy volunteers. Subjects
will be randomized to one of six cohorts and receive a single
infusion of iMod.Fc (ATYR1923) or placebo. Doses of iMod.Fc
(ATYR1923) will range from 0.03 mg/kg up to 5.0 mg/kg. Primary
outcome measures will assess safety and tolerability in subjects
for up to one month following dosing.
For additional information on this study, please visit
www.anzctr.org.au.
About iMod.Fc (ATYR1923)
aTyr Pharma engineered the first Physiocrine fusion protein,
iMod.Fc (ATYR1923), to enhance the pharmacokinetic properties of
the Physiocrine protein in vivo. The company is developing iMod.Fc
(ATYR1923) as a potential therapeutic for patients with rare
pulmonary diseases with an immune or fibrotic component, including
interstitial lung diseases. This fusion protein, which utilizes the
Fc region of an antibody, also potentially represents a novel
Fc-Physiocrine platform for future Physiocrine-based therapies.
About Interstitial Lung Diseases
Interstitial lung disease refers to a complex group of pulmonary
disorders primarily affecting the pulmonary interstitium. Most of
these disorders cause progressive scarring of lung tissue,
eventually affecting the ability to breathe and the transfer of
oxygen into the bloodstream. ILDs can develop in response to
environmental injury, auto-immune mediated inflammation, or from
unknown causes. The spectrum of ILDs includes idiopathic pulmonary
fibrosis, sarcoidosis, hypersensitivity pneumonitis, and connective
tissue disease-associated ILDs among others.
About Physiocrines
Physiocrines comprise naturally occurring proteins that aTyr
believes promote homeostasis, a fundamental process of restoring
stressed or diseased tissue to a healthier state. Physiocrines are
extracellular signaling regions of tRNA synthetases, an ancient
family of enzymes that catalyze a key step in protein synthesis.
Physiocrines offer the opportunity for modulating biological
pathways through newly discovered, naturally occurring mechanisms,
many of which may provide advantages over other types of
immune-modulatory therapeutics, including the potential for
improved patient outcomes and reduced side effect profiles.
About aTyr Pharma
aTyr Pharma is engaged in the discovery and development of
innovative medicines for patients using its knowledge of
Physiocrine biology, a newly discovered set of immunological and
physiological pathways. To date, aTyr has generated three
innovative and unique development programs based on its knowledge
of the Resokine pathway to treat patients suffering from rare,
severe, immune-mediated diseases, as well as various cancers.
aTyr’s two lead programs, Resolaris and iMod.Fc, are agonists of
the Resokine pathway designed to temper immune engagement in
diseases characterized by excessive immune cell involvement. aTyr’s
third program, ORCA, represents a preclinical research program that
targets a novel, proprietary immuno-oncology pathway using
antibodies to enhance the immune response in tumor settings. aTyr
has built an intellectual property estate, to protect its pipeline,
comprising over 220 issued patents or allowed patent applications
that are owned or exclusively licensed, including over 300
potential Physiocrine-based protein compositions. 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 and potential therapeutic benefits of
Resolaris, iMod.Fc, or potential product candidates from our ORCA
program, the ability of the Company to successfully advance its
pipeline or product candidates, undertake certain development
activities (such as clinical trial enrollment and the conduct of
clinical trials) and accomplish certain development goals and the
timing of such activities and development goals, the timing of our
clinical trials, our ability to receive regulatory approvals for,
and commercialize, our product candidates and of reporting results
from our clinical trials, and the scope and strength of our
intellectual property portfolio 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 those 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 the
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 Physiocrine-based product candidates, the risk
that we may cease or delay preclinical or clinical development
activities for any of its 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 its
business and product development plans, as well as those set forth
in our most recent Annual Report on Form 10-K for the year ended
December 31, 2016 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 Relationsmjohnson@atyrpharma.com858-223-1163
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