-- Navenibart Demonstrated 6 Months of HAE
Attack Prevention with 1 or 2 Doses --
-- 90-95% Mean Monthly Attack Rate Reduction
Supporting Chronic Dosing 2 or 4 Times Per Year --
-- 67% Attack-Free Rate Over 6 Months in
Cohorts 2 and 3 --
-- Favorable Safety and Well-Tolerated Profile
--
-- Phase 3 Initiation on Track for Q1 2025
--
Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical
company focused on developing life-changing therapies for allergic
and immunologic diseases, today announced positive final results
from the target enrollment group of 16 patients in the ALPHA-STAR
Phase 1b/2 clinical trial evaluating navenibart (STAR-0215), a
monoclonal antibody inhibitor of plasma kallikrein, in hereditary
angioedema (HAE) patients. These final results demonstrated
reduction in the mean monthly attack rate of 90-95% at 6 months,
favorable safety and tolerability profile, and support both every
three- (Q3M) and every six-month (Q6M) dosing regimens. The results
underscore the potential of navenibart’s profile to be the
market-leading therapy for HAE. Astria is advancing navenibart to
Phase 3 development with trial initiation expected in Q1 2025.
“The results from the ALPHA-STAR Phase 1b/2 trial affirm our
belief in navenibart’s profile and its potential to be a
life-changing, market-leading preventative treatment for HAE
patients,” said Christopher Morabito, M.D., Chief Medical Officer
at Astria Therapeutics. “After one or two doses over six months,
patients experienced rapid onset of robust and durable efficacy,
favorable safety and tolerability, and PK and PD that are
consistent with sustained plasma kallikrein inhibition and Q3M and
Q6M administration. These results are highly consistent with the
interim results we reported in March. We look forward to presenting
these data at an upcoming scientific conference and expect to
initiate Phase 3 development in Q1, pending completion of
discussions with global regulators.”
“These results from the ALPHA-STAR trial are exciting for the
future of the HAE treatment landscape,” said Dr. Aleena Banerji,
Clinical Director MGH Allergy and Clinical Immunology Unit. “We
understand from people living with HAE that the disease and
treatment burden can weigh heavily on their physical and mental
health. I am optimistic that a therapy with infrequent dosing, a
well-tolerated profile, and a trusted mechanism and modality could
alleviate the burden for patients.”
ALPHA-STAR is a dose-ranging proof-of-concept trial in adults
with HAE Type 1 or 2 designed to assess safety, tolerability,
efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and quality
of life in patients receiving single and multiple doses of
navenibart in three cohorts delivered subcutaneously to prevent
attacks in HAE. All cohorts began with an eight-week run-in period
to measure baseline HAE attacks and safety, efficacy, PK, and PD
are assessed through 6-months (Day 168) after the last dose
received. Among the target enrollment (n=16), 88% had Type 1 HAE,
the average age was 46 years, and 56% were female.
Cohort 1 evaluated a 450 mg dose (n=4). Results show that, on
average, over 6 months:
- 91% reduction in monthly attack rate
- 96% reduction in moderate and severe attacks
- 94% reduction in acute rescue medication use
- 50% of patients were attack-free through 3 months of follow-up,
and 25% were attack-free through 6 months of follow-up
Cohort 2 evaluated a 600 mg dose followed by a 300 mg dose three
months later (n=6). Results show that, on average, over 6
months:
- 95% reduction in monthly attack rate
- 95% reduction in moderate and severe attacks
- 94% reduction in acute rescue medication use
- 67% of patients were attack-free
Cohort 3 evaluated a 600 mg dose followed by a 600 mg dose one
month later (n=6). Results show that, on average, over 6
months:
- 92% reduction in monthly attack rate
- 96% reduction in moderate and severe attacks
- 91% reduction in acute rescue medication use
- 67% of patients were attack-free
PK and PD were consistent with previously reported results and
demonstrated rapid and sustained target plasma kallikrein
inhibition consistent with effective and safe Q3M and Q6M
administration.
Navenibart was generally well-tolerated with no serious
treatment-emergent adverse events (TEAEs) and no discontinuations.
There were four non-severe and quickly resolved treatment-related
TEAEs: one case of dizziness, a transient injection site reaction
(rash), an injection site erythema, and an injection site pruritus.
There were no injection site reactions of pain.
The results shared above are available in the Company’s
corporate presentation in the investor section of www.astriatx.com.
The Company expects to present these data at an upcoming scientific
conference.
All 16 patients have enrolled into ALPHA-SOLAR, a long-term
open-label trial. Initial safety and efficacy data from Q3M and Q6M
dosing in the ALPHA-SOLAR trial are expected mid-2025.
Pending regulatory feedback, the Company plans to initiate the
Phase 3 program in Q1 2025 and expects topline results by year-end
2026.
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 immunologic diseases. Our lead
program, navenibart (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 Instagram @AstriaTx
and on Facebook and LinkedIn.
About Navenibart:
Navenibart is a monoclonal antibody inhibitor of plasma
kallikrein in development for the treatment of HAE. Our goal with
navenibart is to provide rapid and sustained HAE attack prevention
with a validated mechanism and trusted modality administered every
3 and 6 months. We aim to empower people living with HAE to live
life without limitations from their disease.
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 potential significance of the results
from the navenibart Phase 1b/2 ALPHA-STAR clinical trial; our
expectations about the timing of release of initial data from the
ALPHA-SOLAR trial; the expected timing of initiation and receipt of
topline results from the planned navenibart Phase 3 program; the
goals and objectives of the planned navenibart Phase 3 program; the
potential therapeutic benefits of navenibart as a treatment for
HAE; the potential attributes and profile of navenibart as a
treatment for HAE, including its potential to be a life-changing,
market leading preventative treatment for HAE, and our overall
vision and goals for the navenibart program; and our corporate
strategy and vision, including our mission is to bring
life-changing therapies to patients and families affected by
allergic and immunologic 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 related to: 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, initial 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 ALPHA-STAR
Phase 1b/2 clinical trial, may not be replicated in later stage
clinical trials, such as the planned Phase 3 development program,
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 navenibart, STAR-0310, and any other future development
candidates; our ability to manufacture sufficient quantities of
drug substance and drug product for navenibart, STAR-0310, and any
other future product candidates on a cost-effective and timely
basis, and to develop dosages and formulations for navenibart,
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 therefor; our
ability to obtain, maintain and enforce intellectual property
rights for navenibart, STAR-0310 and any other future product
candidates; our potential dependence on collaboration partners;
competition with respect to navenibart, STAR-0310, or any of our
other future product candidates; the risk that survey results,
modeling data and market research may not be accurate predictors of
the commercial landscape for HAE, the ability of navenibart to
compete in HAE and the anticipated position and attributes of
navenibart 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 of STAR-0310 may not
commence, continue or be completed on time, or at all; risks that
results of preclinical studies of STAR-0310 will not be replicated
in clinical trials; 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, 2023 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241211638946/en/
Astria: Investor Relations and
Media: Elizabeth Higgins investors@astriatx.com
Astria Therapeutics (NASDAQ:ATXS)
과거 데이터 주식 차트
부터 11월(11) 2024 으로 12월(12) 2024
Astria Therapeutics (NASDAQ:ATXS)
과거 데이터 주식 차트
부터 12월(12) 2023 으로 12월(12) 2024
