STAR-0310 / Glenmark, Astria Therap - LARVOL DELTA

A Study of STAR-0310 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Astria Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human

Demonstration of Early Proof-of-Concept for STAR-0310, a Long-Acting OX40 Receptor Antagonist: Initial Safety, PK, and PD Results from a Phase 1a Trial (EADV 2025) - P1 | "Preliminary PK and PD exhibited sustained target therapeutic effect for at least 3 months following a single dose, demonstrating early proof of concept for a long-acting differentiated OX40 receptor antagonist. These findings support the potential for infrequent maintenance dosing, including the possibility of dosing intervals as long as every 6 months, which may enhance adherence and reduce the treatment burden for patients with chronic inflammatory diseases, including atopic dermatitis and other immune-mediated diseases."

Clinical • IO biomarker • Late-breaking abstract • P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL2 • IL4 • TNFRSF4 • TNFSF4

Astria Therapeutics Announces Positive Initial Results from the Phase 1a Healthy Subject Trial of STAR-0310 at the European Academy of Dermatology and Venereology (Businesswire) - "STAR-0310 Exhibits Longest-in-Class Half-Life of 68 Days and Cytokine Suppression Lasting At Least 20 Weeks After a Single 300 mg SC Injection, Supporting Potential Every-Six-Month Administration. STAR-0310 Was Well-Tolerated, with no ADCC-Related Treatment-Emergent Adverse Events..."

Late-breaking abstract • P1 data • Atopic Dermatitis

Astria Therapeutics Reports Second Quarter 2025 Financial Results and Provides a Corporate Update (Businesswire) - "STAR-0310, an OX40 inhibitor in development for atopic dermatitis, expected to report initial phase 1a healthy subject results in Q3 2025."

P1 data • Atopic Dermatitis

Unveiling the Underlying Mechanism of Differentiation for STAR-0310, an Anti-OX40 Antibody for Atopic Dermatitis (EAACI 2025) - "Together with data indicating its pure antagonistic properties, STAR-0310 appears to function as a full OX40 antagonist. Clinical trials are currently ongoing."

Atopic Dermatitis • Dermatitis • Immunology • TNFSF4

Astria Therapeutics Reports First Quarter 2025 Financial Results and Provides a Corporate Update (Businesswire) - "The Company initiated a Phase 1a clinical trial of STAR-0310 in healthy subjects in January 2025. The Phase 1a trial is intended to assess the safety, tolerability, pharmacokinetics, and immunogenicity of STAR-0310 in healthy adult participants, with early proof-of-concept (POC) results expected in the third quarter of 2025. Preclinical data supporting the differentiated profile of STAR-0310 was presented at AAAAI in March 2025. STAR-0310 demonstrated an extended half-life in cynomolgus monkeys and STAR-0310 preserved T-cells. STAR-0310 significantly reduced antibody-dependent cellular cytotoxicity (ADCC) on activated T-cells and regulatory T-cells when compared to other anti-OX40 monoclonal antibodies."

P1 data • Preclinical • Atopic Dermatitis

Astria Therapeutics to Present at Upcoming American Academy of Allergy, Asthma and Immunology and World Allergy Organization Joint Congress (Businesswire) - "Astria Therapeutics, Inc...today announced that it will present three posters at the American Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress in San Diego, California on March 2, 2025."

Clinical protocol • P1/2 data • Preclinical • Atopic Dermatitis • Hereditary Angioedema

Preclinical data supporting the differentiated profile of STAR-0310, a novel OX40 antagonistic monoclonal antibody (AAAAI-WAO 2025) - "Results STAR-0310 demonstrated an approximately 8-fold increase in binding affinity to human OX40 compared to telazorlimab...STAR-0310 induced significantly lower ADCC on activated T-cells and regulatory T-cells, compared to an in-house analogue of rocatinlimab (AMG451)...Conclusions These preclinical data support further development of STAR-0310 for the treatment of moderate-to-severe atopic dermatitis and other immunologic diseases. The extended half-life suggests potential for sustainable efficacy and prolonged suppression of disease symptoms."

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study of STAR-0310 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Astria Therapeutics, Inc.

New P1 trial

Astria Therapeutics Announces Initiation of Phase 1a Trial of STAR-0310, a Potential Best-in-Class Monoclonal Antibody OX40 Antagonist for the Treatment of Atopic Dermatitis (Businesswire) - "Astria Therapeutics...announced initiation of a Phase 1a clinical trial of STAR-0310 in healthy subjects. STAR-0310, a high affinity monoclonal antibody OX40 antagonist that incorporates YTE technology, is in development for the potential treatment of atopic dermatitis (AD) and potentially other indications....Astria expects early proof-of-concept results from the Phase 1a trial in the third quarter of 2025....The Phase 1a randomized, double-blind, placebo-controlled single ascending dose trial is evaluating the safety, tolerability, pharmacokinetics, and immunogenicity of STAR-0310 in approximately 40 healthy adult participants."

P1 data • Trial status • Atopic Dermatitis

Astria Therapeutics Announces FDA Clearance of IND Application for STAR-0310, a Monoclonal Antibody OX40 Antagonist for the Treatment of Atopic Dermatitis (Businesswire) - "Astria Therapeutics, Inc...announced the U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for STAR-0310, a monoclonal antibody OX40 antagonist, the company is developing as a potential treatment for atopic dermatitis (AD) and potentially other indications. A Phase 1a trial of STAR-0310 in healthy subjects is expected to initiate in the first quarter of 2025, with early proof-of-concept results expected in the third quarter of 2025. Further, the company anticipates proof-of-concept results in atopic dermatitis patients in the second quarter of 2026."

IND • New P1 trial • P1 data • Atopic Dermatitis • Immunology

Development and characterization of STAR-0310: a novel OX40 antagonistic monoclonal antibody (EAACI 2024) - "STAR-0310 is being compared to telazorlimab, rocatinlimab, and amlitelimab in detailed preclinical pharmacology studies including in vitro potency of T cell proliferation inhibition, cytotoxicity effects on activated T cells and regulatory T cells. Conclusion STAR-0310, an anti-OX40 antibody, demonstrates the potential for increased half-life, high-potency T cell inhibition, and reduced toxicities with minimized effector (ADCC) functions. These promising preclinical findings support the potential use of STAR-0310 in moderate-to-severe AD and other immunologic diseases."

Atopic Dermatitis • Dermatitis • Immunology • TNFSF4

Astria Therapeutics to Present at Upcoming European Academy of Allergy and Clinical Immunology Congress (Businesswire) - "Astria Therapeutics, Inc...announced that it will present two posters at the upcoming European Academy of Allergy and Clinical Immunology (EAACI) Congress in Valencia, Spain on June 1, 2024...Dr. Marcus Maurer, M.D., Professor of Dermatology and Allergy at Charité Universitätsmedizin in Berlin, will present information on ALPHA-SOLAR, a long-term open-label trial of STAR-0215 in people living with HAE...Nikos Biris, Ph.D., Senior Director of Assay Development at Astria Therapeutics, will present information on the characterization of STAR-0310 in a poster....The poster session will take place on Saturday, June 1 at 12:00pm CEST."

Clinical protocol • Preclinical • Hereditary Angioedema • Immunology

Astria Therapeutics to Present at Upcoming Society for Investigative Dermatology Annual Meeting (Businesswire) - "Astria Therapeutics, Inc...today announced that it will present information on the preclinical profile of STAR-0310 at the upcoming Society for Investigative Dermatology (SID) Annual Meeting in Dallas, Texas on May 16, 2024."

Preclinical • Atopic Dermatitis • Immunology

Preclinical profile of STAR-0310, a novel OX40 antagonistic monoclonal antibody (SID 2024) - No abstract available

Preclinical

Astria Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Corporate Update (Businesswire) - "Astria expects to submit an Investigational New Drug (IND) application for STAR-0310 by year-end 2024 and plans to initiate a Phase 1a clinical trial in healthy subjects in the first quarter of 2025, with initial results from the trial expected in the third quarter of 2025. Astria intends to present information on the preclinical profile of STAR-0310 at upcoming scientific conferences in 2024."

IND • New P1 trial • Preclinical • Atopic Dermatitis