Astria Therapeutics Announces Positive Final Results from Target Enrollment in the ALPHA-STAR Phase 1b/2 Trial of Navenibart for HAE
Astria Therapeutics (NASDAQ:ATXS) announced positive final results from the ALPHA-STAR Phase 1b/2 trial of navenibart for hereditary angioedema (HAE). The trial, involving 16 patients, demonstrated significant efficacy with 90-95% mean monthly attack rate reduction over 6 months. Key highlights include:
- 67% attack-free rate in Cohorts 2 and 3
- Favorable safety profile with no serious adverse events
- Support for both quarterly and semi-annual dosing regimens
- Phase 3 initiation planned for Q1 2025
The trial evaluated three cohorts with different dosing regimens, all showing over 90% reduction in monthly attack rates and substantial decreases in moderate/severe attacks. The company expects to present detailed data at an upcoming scientific conference and anticipates topline Phase 3 results by year-end 2026.
Astria Therapeutics (NASDAQ:ATXS) ha annunciato risultati finali positivi dallo studio ALPHA-STAR Phase 1b/2 relativo a navenibart per l'angioedema ereditario (HAE). Lo studio, che ha coinvolto 16 pazienti, ha dimostrato un'efficacia significativa con una riduzione della frequenza degli attacchi mensili del 90-95% in 6 mesi. I punti salienti includono:
- 67% di tasso di attacchi assenti nei Coorti 2 e 3
- Profilo di sicurezza favorevole senza eventi avversi gravi
- Supporto per schemi di dosaggio trimestrali e semestrali
- Inizio della fase 3 previsto per il Q1 2025
Lo studio ha valutato tre coorti con diversi schemi di dosaggio, mostrando tutti oltre il 90% di riduzione nelle frequenze degli attacchi mensili e sostanziali diminuzioni negli attacchi moderati/severi. L'azienda prevede di presentare dati dettagliati in una prossima conferenza scientifica e si aspetta risultati preliminari della fase 3 entro la fine del 2026.
Astria Therapeutics (NASDAQ:ATXS) anunció resultados finales positivos del ensayo ALPHA-STAR fase 1b/2 de navenibart para el angioedema hereditario (HAE). El ensayo, que involucra a 16 pacientes, demostró una eficacia significativa con una reducción del 90-95% en la tasa media de ataques mensuales durante 6 meses. Los aspectos más destacados incluyen:
- 67% de tasa sin ataques en los Grupos 2 y 3
- Perfil de seguridad favorable sin eventos adversos graves
- Apoyo para esquemas de dosificación trimestrales y semestrales
- Inicio de fase 3 previsto para el Q1 2025
El ensayo evaluó tres grupos con diferentes esquemas de dosificación, todos mostrando más del 90% de reducción en las tasas de ataques mensuales y disminuciones significativas en los ataques moderados/severos. La empresa espera presentar datos detallados en una próxima conferencia científica y anticipa resultados preliminares de fase 3 para finales de 2026.
Astria Therapeutics (NASDAQ:ATXS)는 유전성 혈관부종(HAE) 치료제인 navenibart의 ALPHA-STAR 1b/2상 시험에서 긍정적인 최종 결과를 발표했습니다. 16명의 환자가 참여한 이 시험은 6개월 동안 평균 월간 발작 발생률을 90-95% 감소시키는 유의미한 효능을 입증했습니다. 주요 내용은 다음과 같습니다:
- 2차 및 3차 군에서 67%의 발작 없는 비율
- 심각한 부작용 없는 안전성 프로파일
- 분기별 및 반기별 용량 조정에 대한 지원
- 2025년 1분기 3상 시험 개시 예정
이 시험은 다양한 용량 조정을 가진 세 개의 군을 평가하였으며, 모두 월간 발작 발생률이 90% 이상 감소하고 중간/심각한 공격이 상당히 줄어드는 결과를 보였습니다. 회사는 다가오는 과학 회의에서 자세한 데이터를 발표할 계획이며, 2026년 연말까지 3상 시험의 주요 결과를 예상하고 있습니다.
Astria Therapeutics (NASDAQ:ATXS) a annoncé des résultats finaux positifs de l'essai ALPHA-STAR de phase 1b/2 au sujet de navenibart pour l'angioœdème héréditaire (HAE). L'essai, impliquant 16 patients, a démontré une efficacité significative avec une réduction de 90-95% du taux moyen d'attaques mensuelles sur 6 mois. Les principaux points à retenir incluent :
- 67% de taux sans attaque dans les Cohortes 2 et 3
- Profil de sécurité favorable sans événements indésirables graves
- Support pour des régimes de dosage trimestriels et semestriels
- Début de la phase 3 prévu pour le T1 2025
L'essai a évalué trois cohortes avec différents régimes de dosage, montrant tous plus de 90% de réduction des taux d'attaques mensuelles et des diminutions substantielles des attaques modérées/sévères. L'entreprise prévoit de présenter des données détaillées lors d'une prochaine conférence scientifique et anticipe les résultats de la phase 3 d'ici la fin de 2026.
Astria Therapeutics (NASDAQ:ATXS) hat positive Endergebnisse aus der ALPHA-STAR Phase 1b/2 Studie zu navenibart bei hereditärem Angioödem (HAE) bekannt gegeben. Die Studie, an der 16 Patienten teilnahmen, zeigte eine signifikante Wirksamkeit mit einer Reduktion der durchschnittlichen monatlichen Angriffsraten um 90-95% über 6 Monate. Zu den wichtigsten Ergebnissen gehören:
- 67% Angriff-freie Rate in den Kohorten 2 und 3
- Positives Sicherheitsprofil ohne schwerwiegende unerwünschte Ereignisse
- Unterstützung für vierteljährliche und halbjährliche Dosierungsschemata
- Geplanter Beginn der Phase 3 im Q1 2025
Die Studie evaluierte drei Kohorten mit unterschiedlichen Dosierungsschemata, die alle eine Reduktion von über 90% der monatlichen Angriffsraten und erhebliche Rückgänge bei moderaten/schweren Angriffen zeigten. Das Unternehmen erwartet, detaillierte Daten auf einer kommenden wissenschaftlichen Konferenz zu präsentieren und rechnet mit Ergebnissen der Phase 3 bis Ende 2026.
- 90-95% reduction in monthly HAE attack rates across all cohorts
- 67% of patients in Cohorts 2 and 3 were attack-free over 6 months
- 91-94% reduction in acute rescue medication use across cohorts
- Demonstrated efficacy with just 1-2 doses over 6 months
- No serious adverse events reported
- Clear path to Phase 3 with timeline established
- Phase 3 results not expected until end of 2026
- 25% attack-free rate through 6 months in Cohort 1 versus 67% in other cohorts
Insights
-- Navenibart Demonstrated 6 Months of HAE Attack Prevention with 1 or 2 Doses --
-- 90
--
-- Favorable Safety and Well-Tolerated Profile --
-- Phase 3 Initiation on Track for 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),
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, and25% 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
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
Source: Astria Therapeutics, Inc.
FAQ
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