SAN DIEGO, Sept. 10, 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 the first
patient has been dosed in a newly initiated long term-safety
extension study of Resolaris™ for adult patients with
facioscapulohumeral muscular dystrophy (FSHD), a rare and severe
genetic myopathy for which there are currently no approved
treatments.
The open label study is designed to assess the long-term safety,
tolerability and biological activity of Resolaris™ and will include
adult patients who are currently enrolled in an ongoing,
double-blind, placebo-controlled, multiple ascending dose Phase
1b/2 trial of Resolaris™ in adult patients with FSHD. Data
from the Phase 1b/2 study are expected in the fourth quarter of
2015 or first quarter of 2016. The extension study is
expected to continue through mid-2016.
"Our Resolaris extension study takes the next step in developing
a new class of Physiocrine-based medicines for patients who
currently have few options. The trial will also expand our growing
safety and tolerability database over a longer treatment period,"
said John Mendlein, Ph.D., CEO and
executive chairman of aTyr Pharma. "When given in therapeutic
doses, we believe Physiocrine-based therapies may productively
modulate immune processes by rebalancing the immune systems in
chronic rare muscle diseases to provide new options for these
severely affected patients."
Resolaris™ is the first Physiocrine-based therapeutic under
investigation for any disease and is based on a naturally occurring
protein identified by aTyr Pharma. The Company is also planning
trials in additional indications, including early onset FSHD and
limb-girdle muscular dystrophy (LGMD) 2B, and both are expected to
initiate later this year.
For additional information on this study, please visit
www.clinicaltrials.gov.
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 Resolaris™
aTyr Pharma is developing Resolaris™ as a first-in-class
intravenous protein therapeutic for the treatment of rare
myopathies with an immune component. Resolaris™ is derived from a
naturally occurring protein released in vitro by human skeletal
muscle cells. aTyr believes Resolaris™ has the potential to provide
therapeutic benefit to patients with rare myopathies with an immune
component characterized by excessive immune cell involvement.
About FSHD
Facioscapulohumeral muscular dystrophy (FSHD) is a rare genetic
myopathy affecting approximately 19,000 people in the United States for which there are no
approved treatments. The primary clinical phenotype of FSHD is
debilitating skeletal muscle deterioration and weakness. The
symptoms of FSHD develop in a descending pattern, starting with the
face and upper body to the lower body and progressing in a "muscle
by muscle" fashion. In addition to muscle weakness, FSHD patients
often experience debilitating fatigue and chronic pain. The disease
is typically diagnosed by the presence of a characteristic pattern
of muscle weakness and other clinical symptoms, as well as through
genetic testing.
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 facioscapulohumeral muscular dystrophy
(FSHD). Trials are planned in additional indications, including
early onset FSHD and limb-girdle muscular dystrophy (LGMD) 2B.
Trials are also planned for indications in 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. 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 and
Section 21E of the Securities Exchange Act, 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 the safe harbor provisions for forward-looking
statements contained in Section 27A of the Securities Act and
Section 21E of the Securities Exchange Act 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 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.