Astria Therapeutics Presents New Phase 1a Data Confirming Potential for STAR-0125 to Prevent Hereditary Angioedema Attacks with Dosing 2 or 4 Times Per Year at the 2023 American College of Allergy, Asthma, and Immunology Annual Scientific Meeting
11 November 2023 - 12:00AM
Business Wire
Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical
company focused on developing life-changing therapies for allergic
and immunological diseases, is presenting new STAR-0215 data in a
poster presentation at the American College of Allergy, Asthma, and
Immunology (ACAAI) in Anaheim, California that demonstrated
STAR-0215’s profile as a potential HAE preventative therapy with
robust attack suppression and low treatment burden in healthy adult
subjects. These data confirm the potential for STAR-0215 to be
dosed once every three months and every six months.
“These new data, including long-term follow-up from the original
cohorts and initial data from new, higher dose cohorts, support our
vision for STAR-0215 as a first-choice therapy for HAE. These data
confirm our approach to administer STAR-0215 once every three and
every six months in future trials. We intend to provide patients
the option to choose what works best for their lives with a therapy
that has a trusted modality and mechanism,” said Chris Morabito,
M.D., Chief Medical Officer at Astria. “Our Phase 1b/2 ALPHA-STAR
trial in HAE patients is on track and enrolling the third and final
cohort. We now expect to deliver initial proof-of-concept data for
STAR-0215 as a long-acting preventative therapy for HAE in Q1 2024.
Patients from the ALPHA-STAR trial are enrolling in the long-term
open label ALPHA-SOLAR trial to continue receiving STAR-0215, with
data now accruing in patients who have received multiple doses of
STAR-0215.”
In a poster titled, “Support for STAR-0215 Administered Every
Three- or Six-Months for Hereditary Angioedema: Phase 1a Results,”
Dr. William Lumry, M.D., Clinical Professor of Internal Medicine at
the University of Texas Health Science Center at Dallas, is
presenting clinical data including randomized, blinded,
placebo-controlled, single ascending dose safety and tolerability
data. STAR-0215 was well-tolerated, with no serious adverse events
or discontinuations due to an adverse event, and low risk of
injection pain. STAR-0215 achieved potentially therapeutic levels
in less than one day and showed an estimated half-life of up to 127
days. Pharmacokinetic (PK) modeling of potential every three month
and every six month clinical dose regimens over one to two years
predict PK coverage believed to confer HAE attack prevention.
Pharmacodynamic (PD) data showed statistically significant
inhibition of plasma kallikrein for 140 to 224 days after single
doses greater than 100 mg. These results demonstrate early
proof-of-concept in healthy subjects for STAR-0215 as a potential
HAE therapy with favorable safety profile, long half-life, and
durable PD.
About Astria Therapeutics:
Astria Therapeutics is a biopharmaceutical company, and our
mission is to bring life-changing therapies to patients and
families affected by 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. Our second program, STAR-0310, is a monoclonal antibody
OX40 antagonist in preclinical development for the treatment of
atopic dermatitis. Learn more about our company on our website,
www.astriatx.com, or follow us on X and Instagram @AstriaTx and on
Facebook and LinkedIn.
About STAR-0215:
STAR-0215 is a monoclonal antibody inhibitor of plasma
kallikrein in development for the treatment of HAE. Our vision is
for STAR-0215 to be the first-choice preventative treatment for
people with HAE dosed once every three and six months and to make
substantial progress towards normalizing their lives. The Phase
1b/2 ALPHA-STAR trial evaluating STAR-0215 in HAE patients is
ongoing, with initial proof-of-concept results expected in the
first quarter of 2024.
Forward Looking Statements:
This press release contains forward-looking statements within
the meaning of applicable securities laws and regulations
including, but not limited to, statements regarding: our
expectations regarding the meaning and significance of the results
from our STAR-0215 Phase 1a STAR-0215 clinical trial; our
expectations regarding enrollment in the Phase 1b/2 ALPHA-STAR
Trial and the timing of delivery of proof of concept data from such
trial ; our vision for and the potential of STAR-0215 as a
treatment for HAE, including expectations of dosing frequency,
being a first choice preventative therapy and other potential
attributes of STAR-0215; and the goal to meet the unmet needs of
patients with rare and niche allergic and immunological diseases.
The use of words such as, but not limited to, “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “goals,”
“intend,” “may,” “might,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “will,” “would,” or "vision," and
similar words expressions are intended to identify forward-looking
statements. Forward-looking statements are neither historical facts
nor assurances of future performance. Instead, they are based on
Astria’s current beliefs, expectations and assumptions regarding
the future of its business, future plans and strategies, future
financial performance, results of pre-clinical and clinical results
of the Astria’s product candidates and other future conditions.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including risks and uncertainties: changes in applicable
laws or regulations; the possibility that we may be adversely
affected by other economic, business, and/or competitive factors;
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 preclinical
studies may not be replicated in clinical trials, that the
preliminary or interim results from clinical trials may not be
indicative of the final results, that the results of early stage
clinical trials, such as the results from the STAR-0215 Phase 1a
clinical trial, may not be replicated in later stage clinical
trials, including the ALPHA-STAR trial or the planned Phase 3 trial
of STAR-0215, 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, STAR-0310 and any other
future development candidates; our ability to manufacture
sufficient quantities of drug substance and drug product for
STAR-0215, STAR-0310 and any other future product candidates on a
cost-effective and timely basis, and to develop dosages and
formulation for STAR-0215, STAR-0310 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, STAR-0310 and any other
future product candidates; our potential dependence on
collaboration partners; competition with respect to STAR-0215,
STAR-0310 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, the ability of
STAR-0215 to compete in HAE and the anticipated position and
attributes of STAR-0215 in HAE based on clinical data to date, its
preclinical profile, pharmacokinetic modeling, market research and
other data; risks that any of our clinical trials may not commence,
continue or be completed on time, or at all; 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, 2022 and in
other filings that we may make with the Securities and Exchange
Commission.
New risks and uncertainties may emerge from time to time, and it
is not possible to predict all risks and uncertainties. Astria may
not actually achieve the forecasts or expectations disclosed in our
forward-looking statements, and investors and potential investors
should not place undue reliance on Astria’s forward-looking
statements. Neither Astria, nor its affiliates, advisors or
representatives, undertake any obligation to publicly update or
revise any forward-looking statement, whether as result of new
information, future events or otherwise, except as required by law.
These forward-looking statements should not be relied upon as
representing Astria’s views as of any date subsequent to the date
hereof.
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Astria: Investor Relations and
Media: Elizabeth Higgins investors@astriatx.com
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