Astria Therapeutics Announces FDA Clearance of IND Application for STAR-0310, a Monoclonal Antibody OX40 Antagonist for the Treatment of Atopic Dermatitis
Astria Therapeutics has announced FDA clearance of its IND application for STAR-0310, a monoclonal antibody OX40 antagonist aimed at treating atopic dermatitis (AD) and potentially other conditions. The Phase 1a trial is set to begin in Q1 2025 with initial proof-of-concept results expected by Q3 2025. Proof-of-concept results in AD patients are anticipated by Q2 2026. According to Chris Morabito, Chief Medical Officer, STAR-0310 is designed to leverage existing knowledge on OX40 receptor and ligand programs. The drug's high affinity and potency, coupled with low ADCC, could offer a wider therapeutic window and potentially allow dosing as infrequently as every six months due to its long half-life and disease-modifying potential.
Astria Therapeutics ha annunciato l'approvazione della FDA per la sua domanda IND per STAR-0310, un anticorpo monoclonale antagonista dell'OX40, mirato al trattamento della dermatite atopica (AD) e potenzialmente di altre condizioni. Il trial di fase 1a è previsto per iniziare nel primo trimestre del 2025, con i risultati iniziali di proof-of-concept attesi entro il terzo trimestre del 2025. I risultati di proof-of-concept per i pazienti affetti da AD sono previsti entro il secondo trimestre del 2026. Secondo Chris Morabito, Chief Medical Officer, STAR-0310 è progettato per sfruttare le conoscenze esistenti sui programmi del recettore e del ligando OX40. L'alta affinità e potenza del farmaco, associata a una bassa ADCC, potrebbero offrire una finestra terapeutica più ampia e potenzialmente consentire somministrazioni così infrequenti come ogni sei mesi, grazie alla sua lunga emivita e al potenziale di modifica della malattia.
Astria Therapeutics ha anunciado la aprobación de la FDA de su solicitud IND para STAR-0310, un anticuerpo monoclonal antagonista de OX40 dirigido al tratamiento de la dermatitis atópica (AD) y potencialmente otras condiciones. El ensayo de fase 1a comenzará en el primer trimestre de 2025, con resultados iniciales de prueba de concepto esperados para el tercer trimestre de 2025. Se anticipan los resultados de prueba de concepto en pacientes con AD para el segundo trimestre de 2026. Según Chris Morabito, Director Médico, STAR-0310 está diseñado para aprovechar el conocimiento existente sobre los programas de receptor y ligando OX40. La alta afinidad y potencia del fármaco, junto con una baja ADCC, podrían ofrecer una ventana terapéutica más amplia y potencialmente permitir una dosificación tan poco frecuente como cada seis meses debido a su larga vida media y su potencial modificador de la enfermedad.
Astria Therapeutics는 아토피 피부염(AD) 및 잠재적으로 다른 질환을 치료하기 위해 설계된 OX40 길항체인 STAR-0310에 대한 IND 신청이 FDA 승인을 받았다고 발표했습니다. 1a 단계 시험은 2025년 1분기에 시작될 예정이며, 초기 개념 증명 결과는 2025년 3분기까지 예상됩니다. AD 환자에 대한 개념 증명 결과는 2026년 2분기까지 기대되고 있습니다. Chris Morabito 의료 담당자에 따르면, STAR-0310은 OX40 수용체 및 리간드 프로그램에 대한 기존 지식을 활용하기 위해 설계되었습니다. 이 약물의 높은 친화력과 효능, 낮은 ADCC는 더 넓은 치료 창을 제공할 수 있으며, 긴 반감기와 질병 수정 가능성으로 인해 6개월에 한 번씩 투여할 수 있을 가능성도 있습니다.
Astria Therapeutics a annoncé l'approbation par la FDA de sa demande IND pour STAR-0310, un anticorps monoclonal antagoniste OX40 destiné à traiter la dermatite atopique (AD) et potentiellement d'autres conditions. L'essai de phase 1a devrait commencer au premier trimestre de 2025, avec des résultats initiaux de preuve de concept attendus d'ici le troisième trimestre de 2025. Les résultats de preuve de concept chez les patients atteints d'AD sont prévus pour le deuxième trimestre de 2026. Selon Chris Morabito, directeur médical, STAR-0310 est conçu pour tirer parti des connaissances existantes sur les programmes de récepteurs et de ligands OX40. La forte affinité et la puissance du médicament, associées à une faible ADCC, pourraient offrir une fenêtre thérapeutique plus large et potentiellement permettre une posologie aussi peu fréquente que tous les six mois en raison de sa longue demi-vie et de son potentiel modificateur de la maladie.
Astria Therapeutics hat die FDA-Zulassung für ihren IND-Antrag für STAR-0310, einen monoklonalen Antikörper-OX40-Antagonisten zur Behandlung der atopischen Dermatitis (AD) und möglicherweise anderer Erkrankungen, bekannt gegeben. Die Phase-1a-Studie soll im ersten Quartal 2025 beginnen, mit ersten Nachweisen der Machbarkeit, die im dritten Quartal 2025 erwartet werden. Die Nachweise der Machbarkeit bei AD-Patienten werden für das zweite Quartal 2026 erwartet. Laut Chris Morabito, Chief Medical Officer, wurde STAR-0310 entwickelt, um vorhandenes Wissen über OX40-Rezeptor- und Ligandenprogramme zu nutzen. Die hohe Affinität und Potenz des Medikaments sowie die niedrige ADCC könnten ein breiteres therapeutisches Fenster bieten und möglicherweise eine Dosierung alle sechs Monate aufgrund der langen Halbwertszeit und des krankheitsmodifizierenden Potenzials ermöglichen.
- FDA clearance of IND application for STAR-0310.
- Phase 1a trial initiation expected in Q1 2025.
- Early proof-of-concept results expected in Q3 2025.
- Potential for dosing every six months due to long half-life.
- Proof-of-concept results in AD patients not expected until Q2 2026.
Insights
The development strategy appears well-thought-out, with STAR-0310 designed to address previous challenges seen in OX40-targeted therapies. The compound's reported high affinity and potency, combined with low ADCC (antibody-dependent cellular cytotoxicity), suggests potential for an improved safety profile and broader therapeutic window. The projected six-month dosing interval would be notably advantageous compared to current biologics that typically require monthly or bi-monthly administration.
The timeline for clinical development is clearly defined, with Phase 1a initiation in Q1 2025 and early proof-of-concept results expected by Q3 2025. The planned progression to patient trials with results by Q2 2026 indicates a well-structured development pathway.
The extended dosing interval of up to six months could provide a strong competitive advantage in the AD market, where patient compliance and convenience are key differentiators. This feature, combined with the potential for disease modification, could position STAR-0310 favorably against existing treatments.
However, investors should note that meaningful clinical data is still over a year away, with the first proof-of-concept results not expected until Q3 2025. The company will need sufficient capital to fund development through these important milestones.
-- Phase 1a Trial of STAR-0310 in Healthy Volunteers Expected to Initiate in Q1 2025 --
-- Early Proof-of-Concept Results Expected in Q3 2025 --
“We are pleased with the FDA’s acceptance of our IND application for STAR-0310 and the progress it represents for the program,” said Chris Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “We are very excited about the potential for the OX40 mechanism. With the goal of creating the overall best OX40 program, we intentionally have designed STAR-0310 to capitalize on the learnings of OX40 receptor and OX40 ligand programs. STAR-0310's high affinity and high potency in conjunction with low ADCC has the potential to enable a wider therapeutic window, and additionally, STAR-0310 has the potential to be dosed as infrequently as every six months due to its long half-life and potential for disease modification.”
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.
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 about the potential for STAR-0310 to be the best overall OX40 program and the potential therapeutic benefits and potential attributes of STAR-0310 as a treatment for AD; expectations regarding the timing of initiation of a Phase 1a trial for STAR-0310 and the timing of receipt of early proof-of-concept results from such trial; expectations regarding the timing of early proof-of-concept results for STAR-0310 in AD; the potential for STAR-0310 in other indications; and the goal of bringing life changing therapies to patients and families affected by allergic and immunological diseases and to become a leading allergy and immunology company. 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 the following 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, including of navenibart and STAR-0310, 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 navenibart Phase 1a clinical trial and the initial results from the ALPHA-STAR trial, may not be replicated in later stage clinical trials, including additional and final results from the ALPHA-STAR trial or the planned navenibart 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 FDA 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, and devices for such product candidates; our ability to manufacture sufficient quantities of drug substance and drug product for navenibart, STAR-0310, and any other future product candidates, and devices for such product candidates, on a cost-effective and timely basis, and to develop dosages and formulation 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 therefore; 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 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 with respect to the ability of STAR-0310 to compete in AD, the anticipated position and attributes of STAR-0310 in AD based on its preclinical profile, and the ability to develop STAR-0310 for additional indications; 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.
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Astria Contact:
Investor Relations and Media:
Elizabeth Higgins
investors@astriatx.com
Source: Astria Therapeutics, Inc.
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