SAN DIEGO, Nov. 11, 2015 /PRNewswire/ -- aTyr Pharma,
Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the
discovery and development of Physiocrine-based therapeutics to
address severe rare diseases, today announced that it has selected
an Investigational New Drug (IND) Candidate based on an
immuno-modulatory and fibro-modulating Physiocrine domain fused to
an Fc region of a human antibody, iMod.Fc. The selected
iMod.Fc molecule is intended to address patients with severe
pulmonary diseases with an immune and fibrotic component.
"The molecule developed in our iMod.Fc discovery program
represents a major breakthrough as the first engineered Physiocrine
with advantageous pharmaceutical properties designed into our
therapeutic protein, which opens up new possibilities of reaching a
more diverse set of patients with severe lung diseases," said
John Mendlein, Ph.D., CEO and
executive chairman of aTyr Pharma. "This molecule represents a
potential new platform within aTyr. Similar to the process of
taking receptor domains and fusing them to Fc regions, we may be
able to fuse our Physiocrine ligands to the Fc region to enhance
their properties."
In preclinical studies, the selected iMod.Fc molecule has shown
promising results in a well-established rodent model of lung
inflammation and pulmonary fibrosis, induced by a chemotherapeutic
agent known as bleomycin. When given in two therapeutic doses, this
iMod.Fc molecule was comparable to, or outperformed, approved drugs
in reducing lung inflammation and fibrosis in the bleomycin
model. The Company is initiating GMP process development with
a third party manufacturer.
The selected iMod.Fc molecule is the Company's second
physiocrine-based therapeutic development candidate and represents
an expansion of this new class of therapeutics. The Company has
discovered more than 300 Physiocrines with diverse functions that
have potential applications across a variety of conditions,
including severe diseases of the muscle, lung, gut, skin, brain,
and liver.
The Company is advancing Resolaris™, its first
therapeutic candidate, for the treatment of rare myopathies with an
immune component (RMICs), such as facioscapulohumeral muscular
dystrophy (FSHD) and limb girdle muscular dystrophy (LGMD), and
plans are underway for the clinical evaluation of Resolaris in rare
pulmonary diseases with an immune component (RPICs), such as
interstitial lung diseases (ILDs).
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. aTyr is currently focused on
Physiocrines that act as endogenous modulators of the immune
system. Physiocrines offer the opportunity for modulating
biological pathways through newly discovered, naturally occurring
mechanisms, many of which may provide advantages over engineered
immuno-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 clinical development of innovative medicines for
patients suffering from severe rare diseases using its knowledge of
Physiocrine biology, a newly discovered set of physiological
modulators. The Company's lead candidate, Resolaris, is a
first-in-class intravenous protein therapeutic for the treatment of
rare myopathies with an immune component. Resolaris is
currently in a Phase 1b/2 clinical trial in adult patients with
FSHD; a Phase 1b/2 trial in adult patients with LGMD2B or FSHD; and
a Phase 1b/2 trial in patients with an early onset form of
FSHD. An initial trial is planned in rare pulmonary diseases
with an immune component (RPIC) in patients with interstitial lung
disease (ILD). To protect this pipeline, aTyr built an intellectual
property estate comprising 45 issued or allowed patents and over
240 pending patent applications that are solely owned or
exclusively licensed by aTyr. aTyr's key programs are currently
focused on severe, rare diseases characterized by immune
dysregulation for which there are currently limited or no treatment
options. The Company was founded by Professors Paul Schimmel, Ph.D., and Xiang-Lei Yang, Ph.D., two leading aminoacyl
tRNA synthetase scientists at The Scripps
Research Institute. For more information, please visit
http://www.atyrpharma.com.
Forward-Looking Statements
Statements we make in this
press release may include statements which are not historical facts
and are considered forward-looking within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E
of the Securities Exchange Act of 1934, which 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 of
Resolaris, the ability of the Company to undertake certain
development activities (such as clinical trial enrollment and the
conduct of clinical trials) and accomplish certain development
goals, and the timing of initiation of additional clinical trials
and of reporting results from our clinical trials 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, as well as those set forth in the prospectus
for our recent offering of common stock and our most recent
Quarterly Report on Form 10-Q. 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.
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SOURCE aTyr Pharma, Inc.