-- STAR-0215 Dosed Once or Twice Over 6 Months
Reduced Monthly Attack Rates by 90-96%, Supporting Chronic Dosing 2
or 4 Times Per Year --
-- 92-100% Decrease in Moderate or Severe
Attacks and 91-95% Reduction in Attacks Requiring Rescue
Medications with STAR-0215 --
-- Very Well-Tolerated with No Serious Adverse
Events and No Discontinuations --
-- Phase 3 Initiation on Track for Q1 2025,
with Top-Line Results Expected by Year End 2026 --
-- Current Cash Expected to Fund Company into
Mid-2027 --
-- Conference Call Today at 8:30am ET –
Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical
company focused on developing life-changing therapies for allergic
and immunological diseases, today announced positive initial
proof-of-concept results from the ALPHA-STAR Phase 1b/2 clinical
trial evaluating STAR-0215, a monoclonal antibody inhibitor of
plasma kallikrein, in hereditary angioedema (HAE) patients. Initial
results demonstrate a favorable safety and tolerability profile,
mean monthly attack rate reduction of 90-96% for up to 6 months of
follow up, and support both three- (Q3M) and six-month (Q6M) dosing
regimens. Based on the positive results, Astria plans to advance
STAR-0215 to Phase 3 development with trial initiation expected in
Q1 2025 and top-line results expected by year-end 2026.
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“We are thrilled with these initial results from ALPHA-STAR and
believe that STAR-0215 can be a transformative therapy for patients
that greatly reduces their disease and treatment burdens,” said
Christopher Morabito, M.D., Chief Medical Officer at Astria
Therapeutics. “These results give us conviction that we will be
able to deliver STAR-0215 once every three and six months, and we
look forward to progressing this program into Phase 3 as quickly as
possible.”
“The initial results of the ALPHA-STAR trial represent a very
exciting step forward in the HAE treatment landscape,” said Marcus
Maurer, M.D., Executive Director of the Institute of Allergology at
Charite – Universitatsmedizin Berlin. “STAR-0215 has the potential
to help patients manage their disease with a mechanism and modality
that they trust, but with a substantially improved dosing regimen
and the ability to administer without pain. Based on this profile,
STAR-0215 has the potential to normalize the lives of people living
with HAE.”
"Thanks to the enthusiasm for STAR-0215, the ALPHA-STAR trial
enrolled ahead of schedule, enabling us to report these data
earlier than originally scheduled,” said Jill C. Milne, Ph.D.,
Chief Executive Officer. “We believe STAR-0215 has the potential to
be the first-choice HAE treatment and I am thankful for the HAE
community and the Astria team for helping us to achieve today’s
important milestone.”
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
STAR-0215 delivered subcutaneously to prevent attacks in HAE.
Target enrollment of 16 patients has been achieved and all doses
have been administered. 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. The initial efficacy and safety data-cut was as of March
13, 2024.
Cohort 1 evaluated a 450 mg dose and all four patients have
completed 6 months of follow-up. Efficacy observations compared to
baseline through 6 months of follow-up were as follows:
- 92% reduction in monthly attack rate
- 96% reduction in moderate and severe attacks
- 91% reduction in acute rescue medication use
- 50% of patients were attack-free through 3 months of
follow-up
Cohort 2 evaluated a 600 mg dose followed by a 300 mg dose three
months later, on Day 84. The Company plans to evaluate this dosing
regimen in Phase 3. All six patients have completed 3 months of
follow up and three patients have completed 6 months of follow-up.
Efficacy observations compared to baseline through 6 months of
follow-up were as follows:
- 96% reduction in monthly attack rate
- 98% reduction in moderate and severe attacks
- 94% reduction in acute rescue medication use
- 67% of patients were attack-free
- 100% of patients were attack-free in the first month after
dosing, demonstrating rapid onset of action
Cohort 3 received a 600 mg dose followed by a 600 mg dose one
month later, on Day 28. Four of six patients have completed 3
months of follow-up. Efficacy observations compared to baseline
through 3 months of follow-up were as follows:
- 90% reduction in monthly attack rate
- 100% reduction in moderate and severe attacks
- 95% reduction in acute rescue medication use
- 50% of patients were attack-free
Preliminary PK and PD data are consistent with Phase 1a data in
healthy subjects and consistent with observed efficacy.
STAR-0215 was generally well-tolerated with no serious
treatment-emergent adverse events (TEAEs) and no discontinuations.
There were two treatment-related TEAEs (both mild), one of which
was a case of dizziness and the other a transient injection site
reaction (rash). There were no injection site reactions of
pain.
After completion of the ALPHA-STAR trial, patients have the
opportunity to continue to receive STAR-0215 every three or six
months in the long-term open label ALPHA-SOLAR trial. Initial
safety and efficacy data from Q3M and Q6M dosing in the ALPHA-SOLAR
trial are expected mid-2025.
The observed efficacy, PK, PD, and safety and tolerability
profile of STAR-0215 support advancement of STAR-0215 into Phase 3
development. To progress STAR-0215 to market as quickly as
possible, the Company plans to focus the Phase 3 program on Q3M
dosing initially, immediately followed by a second trial to support
label expansion to Q6M. Pending regulatory feedback, the Company
expects to start a pivotal Q3M Phase 3 trial in Q1 2025, with
top-line results expected by year-end 2026.
The Company expects that its current cash, cash equivalents, and
short-term investments of $246.5 million as of December 31, 2023,
plus $137.1 million from financing activity in the first quarter of
2024, will be sufficient to fund the Company into mid-2027
including all STAR-0215 program activities through the completion
of a planned Q3M Phase 3 pivotal trial as well as advancing the
Company’s STAR-0310 OX40 program through IND submission and early
proof-of-concept results from a Phase 1a trial.
Webcast Information
The Company will host a webcast today at 8:30am ET. Interested
parties may join the webcast via the Investors section of the
Astria website, www.astriatx.com or with following the link
https://lifescievents.com/event/astriatx/. 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 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 goal with
STAR-0215 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. Pending regulatory
feedback, we expect to initiate a pivotal Q3M Phase 3 trial in Q1
of 2025 with top-line results expected by year-end 2026.
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 initial
results from the Phase 1b/2 ALPHA-STAR clinical trial of STAR-0215,
and that the results from such trial will allow us to move directly
into a Phase 3 trial of STAR-0215 as a potential treatment for
hereditary angioedema (HAE); the expected timing of initiation and
design of the planned Phase 3 trials of STAR-0215; the potential
therapeutic benefits of STAR-0215 as a treatment for HAE; the
potential market impact of STAR-0215 as a treatment for HAE and our
vision and goals for the STAR-0215 program; expectations regarding
the timing of initiation and planned design of clinical trials for
STAR-0310 in AD; expectations regarding the timing and nature of
anticipated data from planned trials of STAR-0310; our anticipated
cash runway; and our corporate strategy and vision, including 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 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 initial results from the
ALPHA-STAR Phase 1b/2 clinical trial, may not be replicated in
later stage clinical trials, 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 formulations 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 therefor; 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, modeling data 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 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/20240325940590/en/
Astria: Investor Relations and
Media: Elizabeth Higgins investors@astriatx.com
Grafico Azioni Astria Therapeutics (NASDAQ:ATXS)
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Da Dic 2024 a Gen 2025
Grafico Azioni Astria Therapeutics (NASDAQ:ATXS)
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Da Gen 2024 a Gen 2025
