aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged
in the discovery and development of innovative medicines from its
proprietary tRNA synthetase biology platform, today announced that
clinical data for efzofitimod (ATYR1923), its lead therapeutic
candidate, will be presented in two posters today from 11:15AM –
1:15PM PT at the American Thoracic Society (ATS) 2022 International
Conference in San Francisco, CA.
“These posters present the clinical
proof-of-concept data from the recently completed Phase 1b/2a study
of efzofitimod in patients with pulmonary sarcoidosis. Efzofitimod
was safe and well tolerated and demonstrated dose-dependent
improvements in key physiologic and quality of life measures in the
context of a steroid taper, which according to medical experts, is
the first study of any therapy to do so in pulmonary sarcoidosis
patients,” said Sanjay S. Shukla, M.D., M.S., President and CEO of
aTyr. “Based on these findings, we are advancing efzofitimod to a
pivotal Phase 3 study, which we expect to initiate in the third
quarter of this year. EFZO-FIT™, a global, multi-center study to
evaluate the efficacy and safety of efzofitimod in patients with
pulmonary sarcoidosis, will be the first study in this patient
population to evaluate steroid reduction as the primary endpoint
and presents an opportunity to deliver a transformative therapy
with clinically meaningful outcomes to these patients.”
Details of the poster presentations appear
below. The corresponding abstracts are available for review online
on the conference website. The posters will be available on the
aTyr website once presented.
Title: Safety and Efficacy ATYR1923, a Novel
Immunomodulator for Pulmonary Sarcoidosis: Results of a Phase 1b/2a
Randomized Placebo-Controlled Trial Abstract
Number: 3932Poster Number:
P559Poster Session: Inflammatory Modulation in
Sarcoidosis, Lung Transplant, and Other DiseasesDate and
Time: Tuesday, May 17, 2022 from 11:15AM – 1:15PM PT
Location: Area G, Hall F (North Building,
Exhibition Level), Moscone Center
The poster presents findings from a Phase 1b/2a
randomized, double-blind, placebo-controlled study of efzofitimod
(ATYR1923) in patients with pulmonary sarcoidosis. Monthly dosing
of efzofitimod was safe and well tolerated. There was a
dose-dependent improvement in efficacy parameters, including
corticosteroid (CS) taper, percent-predicted forced vital capacity
(FVCPP), and patient reported outcomes. All efzofitimod treatment
groups had lower CS use at week 24 compared to placebo, with the
largest difference observed in the 5.0 mg/kg treatment group, where
three patients were able to taper off CS completely and maintain
that taper through the completion of the study. The two higher
doses of efzofitimod, 3.0 mg/kg and 5.0 mg/kg, resulted in
improvements in FVCPP and percent-predicted diffusing capacity of
the lungs for carbon monoxide (DLCOPP) through week 24 compared to
placebo. Clinically meaningful and statistically significant
improvements at week 24 were observed for key symptom measures in
the 5.0 mg/kg treatment group. In small studies such as this, which
was not powered for statistical significance, dose dependent
improvements are strong evidence for efficacy.
Title: ATYR1923 Treatment Reduces
Pro-Inflammatory Serum Biomarkers in Pulmonary Sarcoidosis
PatientsAbstract Number: 3933Poster
Number: P560Poster Session: Inflammatory
Modulation in Sarcoidosis, Lung Transplant, and Other
DiseasesDate and Time: Tuesday, May 17, 2022 from
11:15AM – 1:15PM PT Location: Area G, Hall F
(North Building, Exhibition Level), Moscone Center
The poster presents clinical biomarker findings
from a Phase 1b/2a randomized, double-blind, placebo-controlled
study of efzofitimod (ATYR1923) in patients with pulmonary
sarcoidosis. Efzofitimod demonstrated dose dependent control of
inflammatory and sarcoidosis disease biomarkers over 24 weeks in
the context of a corticosteroid taper. The affected inflammatory
biomarkers, including IFN-γ, IL-6, IP-10, MCP-1 and TNFa, and key
markers of sarcoidosis, including IL-2Ra, SAA, ACE enzyme and ACE
protein, are key drivers of sarcoidosis and other interstitial lung
disease and consistent with results from preclinical animal models
and a Phase 2 study of efzofitimod in hospitalized COVID-19
pneumonia patients. These results are the first demonstration of
efzofitimod’s anti-inflammatory mechanism in patients with
pulmonary sarcoidosis. These analyses were exploratory and not
adjusted for multiplicity to control for false positive results and
will need to be confirmed in a larger study.
An additional abstract further exploring the
molecular and cellular mechanism of action of efzofitimod in
sarcoidosis that was also accepted for presentation will instead be
submitted for inclusion at another medical conference later this
year.
About
Efzofitimod
aTyr is developing efzofitimod as a potential
therapeutic for patients with fibrotic lung disease. Efzofitimod, 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 innate and adaptive immune response in inflammatory
disease states. aTyr’s lead indication for efzofitimod is pulmonary
sarcoidosis, a major form of interstitial lung disease. Clinical
proof-of-concept for efzofitimod was recently established in a
Phase 1b/2a multiple-ascending dose, placebo-controlled study of
efzofitimod in patients with pulmonary sarcoidosis, which
demonstrated safety and a consistent dose response and trends of
benefit of efzofitimod compared to placebo on key efficacy
endpoints, including steroid reduction, lung function, clinical
symptoms and inflammatory biomarkers. aTyr intends to initiate
EFZO-FIT™, a Phase 3 study of efzofitimod in pulmonary sarcoidosis
patients, in the third quarter of 2022.
About aTyr
aTyr is a biotherapeutics company engaged in the
discovery and development of innovative medicines from its
proprietary tRNA synthetase biology platform. 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 efzofitimod, a clinical-stage
product candidate which binds to the neuropilin-2 receptor and is
designed to downregulate immune engagement in fibrotic lung
disease. For more information, please visit 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 efzofitimod; timelines and plans with respect to
certain development activities (such as the timing of 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 Quarterly Report on Form 10-Q for the
quarter ended March 31, 2022 filed with the SEC on May 10, 2022 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 DunstonDirector,
Investor Relations and Corporate
Communicationsadunston@atyrpharma.com
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