-- Shown Early Proof of Concept of STAR-0215’s
Profile as a Long-Acting Plasma Kallikrein Inhibitor with Estimated
Half-Life of Up to 110 Days --
-- Plans to Initiate ALPHA-STAR Phase 1b/2
Trial in Hereditary Angioedema Patients in Q1 2023 --
-- Results to be discussed in a Webcast Today
at 8:30am ET --
Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical
company developing STAR-0215 for the treatment of hereditary
angioedema (HAE), today announced positive preliminary results from
the Phase 1a clinical trial of STAR-0215 in healthy subjects
establishing early proof of concept of STAR-0215 as a potential
long-acting preventative treatment for HAE. STAR-0215 was
well-tolerated at all doses studied. The results showed rapid and
sustained drug levels consistent with clinical benefit and
sustained target engagement with plasma kallikrein inhibition for
at least three months, supporting the potential for STAR-0215 to be
dosed once every three months or less frequently. Astria plans to
initiate the ALPHA-STAR Phase 1b/2 trial in HAE patients in Q1
2023.
“These results mark a significant milestone for STAR-0215 and
Astria. We are excited that STAR-0215 has shown early proof of
concept for its target profile: of being a long-acting preventative
therapy for HAE, with a best-in-class PK profile, and dosing once
every 3 months or less frequently,” said Jill C. Milne, Ph.D.,
Chief Executive Officer at Astria. “We aim to change the way those
affected by HAE live with their disease and see these preliminary
results as a critical step bringing us closer to improving
patients’ lives. We are looking forward to bringing STAR-0215 to
patients in the ALPHA-STAR trial early next year.”
“Patients want treatment options that can normalize their lives.
I am pleased to see STAR-0215 moving forward in clinical
development to patients,” said William Lumry, M.D., Founder and
Medical Director of the AARA Research Center. “We understand the
need from the HAE community for an effective treatment with less
burdensome dosing administration and are excited to see that
potential in STAR-0215.”
STAR-0215 is a monoclonal antibody inhibitor of plasma
kallikrein designed to provide long-acting, effective HAE attack
prevention. The Phase 1a randomized, double-blind,
placebo-controlled single ascending dose trial of STAR-0215
evaluated the safety, pharmacokinetics (PK), and pharmacodynamics
(PD) of STAR-0215 at a single U.S. center. Twenty-five healthy
adult subjects each received a single subcutaneous administration
of one of three dose levels of 100mg, 300mg, or 600mg of STAR-0215
or placebo, and subjects are being followed for safety, PK, and PD
for a total of 224 days. Preliminary data includes safety through
84 days for all three cohorts, PK and PD for the 100 mg and 300 mg
cohorts through 84 days and PK and PD through 56 days for the 600
mg cohort.
Blinded safety results showed that STAR-0215 was well-tolerated
at all dose levels. The most common treatment-related adverse event
was mild (Grade 1), self-resolving injection site reaction, which
most commonly was site redness. There were no clinically relevant
changes in liver enzymes or coagulation parameters, serious adverse
events or discontinuations. In the 300 and 600 mg dose groups, PK
and PD results were consistent with clinical benefit up to three
months, with an estimated half-life of STAR-0215 up to 110 days.
Rapid and sustained drug levels consistent with clinical benefit
support the potential for dosing STAR-0215 once every three months
or less frequently. PD results showed rapid and robust target
engagement with plasma kallikrein inhibition through at least three
months with a single dose of STAR-0215. The levels of inhibition,
40 to 60% decrease in FXIIa-activated cleaved high molecular weight
kininogen, are consistent with the levels shown to prevent attacks
in people living with HAE.
The results support advancing STAR-0215 to a Phase 1b/2 trial,
ALPHA-STAR, expected to initiate in Q1 2023. This global,
multi-center, open-label, single and multiple dose proof-of-concept
clinical trial in people with HAE, will evaluate safety,
tolerability, HAE attack rate, PK, PD, and quality of life in
patients. Initial results are expected from the single and multiple
dose cohorts in mid-2024. The results from the Phase 1a trial also
suggest that there could be an opportunity to dose STAR-0215 less
frequently. Astria plans to evaluate the potential for 6-month
dosing with additional healthy subject cohorts in the Phase 1a
trial starting in Q1 2023 with initial results expected in Q4
2023.
Webcast Information: Interested parties may join the
webcast via the Investors section of the Astria website,
www.astriatx.com or with the following link:
https://edge.media-server.com/mmc/p/rchg8tau.
Please connect to the webcast several minutes prior to the start
of the broadcast to ensure adequate time for any software download
that may be required. The webcast will be archived for 90 days.
About Astria Therapeutics: Astria Therapeutics is a
biopharmaceutical company, and our mission is to bring
life-changing therapies to patients and families affected by rare
and niche allergic and immunological diseases. Our lead program,
STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein
in clinical development for the treatment of hereditary
angioedema.
Forward Looking Statements This press release contains
forward-looking statements of Astria Therapeutics, Inc. (“Astria,”
the “Company,” “we”, “our” or “us”) within the meaning of
applicable securities laws and regulations, including statements
with respect to: expectations regarding the potential significance
of the preliminary results from the Phase 1a STAR-0215 trial, the
plans to add additional cohorts to the trial and the anticipated
nature and timing of receipt of the data from such additional
cohorts; expectations regarding the timing of initiation, design
and timing and nature of the anticipated proof of concept results
from the planned Phase 1b/2 clinical trial of STAR-0215; the longer
term development plans for STAR-0215; the potential attributes and
differentiated profile of STAR-0215 as a treatment for HAE,
including its potential best-in-class pharmacokinetic profile,
potential dosing frequency, clinical benefit and those suggested by
the preliminary results from the STAR-0215 Phase 1a trial,
preclinical and pharmacokinetic modeling data; the potential
commercial opportunity for STAR-0215 in HAE; the need for effective
treatments for HAE; the potential for six-month dosing of
STAR-0215; and the Company’s goal to meet the unmet needs of
patients with rare and niche allergic and immunological diseases.
We use words such as "aims," “anticipate,” “believe,” “estimate,”
“expect,” "goals," “hope,” “intend,” “may,” "opportunity," “plan,”
“predict,” “project,” “target,” “potential,” “would,” "vision,"
“can,” “could,” “should,” “continue,” and other words and terms of
similar meaning to help identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including risks and uncertainties related to:
changes in applicable laws or regulations; the possibility that we
may be adversely affected by other economic, business, and/or
competitive factors, including the COVID-19 pandemic; risks
inherent in pharmaceutical research and development, such as:
adverse results in our drug discovery, preclinical and clinical
development activities, the risk that the results of pre-clinical
studies may not be replicated in clinical studies, that the
preliminary results from the Phase 1a trial may not be indicative
of the final results, that the results of early stage clinical
studies may not be replicated in later stage clinical studies, the
risk that we may not be able to enroll sufficient patients in our
clinical trials on a timely basis, and the risk that any of our
clinical trials may not commence, continue or be completed on time,
or at all; decisions made by, and feedback received from, the U.S.
Food and Drug Administration and other regulatory authorities on
our regulatory and clinical trial submissions and other feedback
from potential clinical trial sites, including investigational
review boards at such sites, and other review bodies with respect
to STAR-0215 and any other future development candidates; our
ability to manufacture sufficient quantities of drug substance and
drug product for STAR-0215 and any other future product candidates
on a cost-effective and timely basis, and to develop dosages and
formulation for STAR-0215 and any other future product candidates
that are patient-friendly and competitive; our ability to develop
biomarker and other assays, along with the testing protocols
therefore; our ability to obtain, maintain and enforce intellectual
property rights for STAR-0215 and any other future product
candidates; our potential dependence on collaboration partners;
competition with respect to STAR-0215 or any of our other future
product candidates; the risk that survey results and market
research may not be accurate predictors of the commercial landscape
for HAE and the anticipated position and attributes of STAR-0215 in
HAE based on its clinical data to date, pre-clinical profile,
pharmacokinetic modeling and other data; our ability to manage our
cash usage and the possibility of unexpected cash expenditures; our
ability to obtain necessary financing to conduct our planned
activities and to manage unplanned cash requirements; the risks and
uncertainties related to our ability to recognize the benefits of
any additional acquisitions, licenses or similar transactions; and
general economic and market conditions; as well as the risks and
uncertainties discussed in the “Risk Factors” section of our Annual
Report on Form 10-K for the period ended December 31, 2021, and in
other filings that we may make with the Securities and Exchange
Commission. These forward-looking statements should not be relied
upon as representing our view as of any date subsequent to the date
of this press release, and we expressly disclaim any obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20221215005251/en/
Investor relations: Andrea Matthews
investors@astriatx.com
Media: Elizabeth Higgins media@astriatx.com
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