A Phase 2 Long-Term Open-Label Trial to Assess the Safety and Efficacy of Repeat Dosing of STAR-0215 in Adult Patients with Hereditary Angioedema (The ALPHA-SOLAR Trial)

The goal of this trial is to enable the collection of information about long-term safety and clinical activity of STAR-0215 in participants with hereditary angioedema (HAE). Participants will receive repeat doses of STAR-0215 for up to 5 years.

Start Date26 Sep 2023

Sponsor / Collaborator

Astria Therapeutics, Inc.

NCT05695248 / Active, not recruitingPhase 1/2

A Phase 1b/2 Single and Multiple Dose Study to Assess the Safety, Tolerability, Clinical Activity, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of STAR-0215 in Participants With Hereditary Angioedema (The ALPHA-STAR Trial)

The goal of this clinical trial is to test the drug STAR-0215 in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of STAR-0215, and two other groups will get 2 doses of STAR-0215. Researchers will study the effects of STAR-0215 in participants with HAE as this is the first time that the drug has been given to participants with HAE.

Start Date21 Feb 2023

Sponsor / Collaborator

Astria Therapeutics, Inc.

NCT05477160 / CompletedPhase 1

A First-in-Human, Phase 1a, Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of STAR-0215 in Healthy Adult Subjects

This is a first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single subcutaneous (SC) or intravenous (IV) administration of STAR-0215 in healthy adult participants.

Start Date27 Jul 2022

Sponsor / Collaborator

Astria Therapeutics, Inc.

100 Clinical Results associated with Astria Therapeutics, Inc.

0 Patents (Medical) associated with Astria Therapeutics, Inc.

Literatures (Medical) associated with Astria Therapeutics, Inc.

01 Nov 2023·The Journal of pharmacology and experimental therapeutics

STAR-0215 is a Novel, Long-Acting Monoclonal Antibody Inhibitor of Plasma Kallikrein for the Potential Treatment of Hereditary Angioedema.

Article

Author: Omer, Charles ; Harwin, Peter ; Violin, Jonathan ; Chung, Jou-Ku ; Chandran, Sachin ; Bista, Pradeep ; Kiselak, Tomas ; Nichols, Andrew ; Bedian, Vahe ; Biris, Nikolaos ; Dagher, Rafif ; Fuller, James

Hereditary angioedema (HAE) is a rare autosomal dominant disorder caused by a deficiency in functional C1 esterase inhibitor, a serpin family protein that blocks the activity of plasma kallikrein. Insufficient inhibition of plasma kallikrein results in the overproduction of bradykinin, a vasoactive inflammatory mediator that produces both pain and unpredictable swelling during HAE attacks, with potentially life-threatening consequences. We describe the generation of STAR-0215, a humanized IgG1 antibody with a long circulating half-life (t_1/2) that potently inhibits plasma kallikrein activity, with a >1000-fold lower affinity for prekallikrein and no measurable inhibitory activity against other serine proteases. The high specificity and inhibitory effect of STAR-0215 is demonstrated through a unique allosteric mechanism involving N-terminal catalytic domain binding, destabilization of the activation domain, and reversion of the active site to the inactive zymogen state. The YTE (M252Y/S254T/T256E) modified fragment crystallizable (Fc) domain of STAR-0215 enhances pH-dependent neonatal Fc receptor binding, resulting in a prolonged t_1/2 in vivo (∼34 days in cynomolgus monkeys) compared with antibodies without this modification. A single subcutaneous dose of STAR-0215 (≥100 mg) was predicted to be active in patients for 3 months or longer, based on simulations using a minimal physiologically based pharmacokinetic model. These data indicate that STAR-0215, a highly potent and specific antibody against plasma kallikrein with extended t_1/2, is a potential agent for long-term preventative HAE therapy administered every 3 months or less frequently. SIGNIFICANCE STATEMENT: STAR-0215 is a YTE-modified immunoglobulin G1 monoclonal antibody with a novel binding mechanism that specifically and potently inhibits the enzymatic activity of plasma kallikrein and prevents the generation of bradykinin. It has been designed to be a long-lasting prophylactic treatment to prevent attacks of HAE and to decrease the burden of disease and the burden of treatment for people with HAE.

01 Jan 2023·Journal of neuromuscular diseases

A Mixed-Method Study Exploring Patient-Experienced and Caregiver-Reported Benefits and Side Effects of Corticosteroid Use in Duchenne Muscular Dystrophy.

Article

Author: Peay, Holly ; Fischer, Ryan ; Denger, Brian ; Donovan, Joanne M ; Armstrong, Niki ; Porter, Katherine ; Hasham, Shabir ; Scavina, Mena T

BACKGROUNDCorticosteroids are recommended to all people with Duchenne as standard of care; patient experience data is important to guide corticosteroid decision making and as a comparator for new treatment options.OBJECTIVEThis study assesses patient and caregiver-reported benefits and side effects from corticosteroids to treat Duchenne muscular dystrophy, their importance, and satisfaction.METHODSUsing one-on-one interviews (n = 28) and an online survey (n = 236), parents and adults with Duchenne reported corticosteroid benefits and side effects rated as both experienced and important.RESULTSBenefits to breathing, heart function, arm strength, slowing progression of weakness, and getting around were rated as particularly important, regardless of ambulatory status. Important side effects included increased fracture risk, unwanted weight gain, and diabetes/prediabetes. Parents rated behavior issues and adults rated delayed puberty as having high importance. Being ambulatory was independently associated with reporting more net benefit (p = 0.02). For side effects, parent scores were significantly higher than adult score (p = 0.02). Corticosteroid type was not significant. Participants were, overall, satisfied with corticosteroids (means ranging from 6.2 to 7.7 on a scale of 0-10), with no significant differences based on corticosteroid type.CONCLUSIONSOverall, most participants were satisfied with the use of corticosteroids. While a range of side effects were rated as important and relatively common, individuals using corticosteroids and their caregivers indicate that benefits outweigh the side effects. Qualitative data indicate that high acceptability is influenced by lack of treatment alternatives. Patient experience data on use of corticosteroids in Duchenne may be relevant to drug development, regulatory assessment of new treatments, and to families making decisions about corticosteroid use.

14 Sep 2021·Journal of Neuromuscular Diseases

A Randomized, Double-Blind, Placebo-Controlled, Global Phase 3 Study of Edasalonexent in Pediatric Patients with Duchenne Muscular Dystrophy: Results of the PolarisDMD Trial

Article

Author: Marks, Warren ; Statland, Jeffrey ; Tulinius, Mar ; McMillan, Hugh J. ; Müller-Felber, Wolfgang ; Vijayakumar, Kayal ; Nguyen, Cam-Tu ; Ryan, Monique M. ; Lee Sweeney, H. ; Burnette, W. Bryan ; Neil Knierbein, Erin ; McDonald, Craig M. ; Wagner, Kathryn R. ; Mancini, Maria ; MacDougall, James ; Donovan, Joanne M. ; Finkel, Richard S. ; Johannsen, Jessika ; Nance, Jessica ; Phan, Han C. ; Tian, Cuixia ; O’Rourke, Declan ; McCullagh, Gary ; Mathews, Katherine D. ; Finanger, Erika ; Eagle, Michelle

Background: Edasalonexent (CAT-1004) is an orally-administered novel small molecule drug designed to inhibit NF-κB and potentially reduce inflammation and fibrosis to improve muscle function and thereby slow disease progression and muscle decline in Duchenne muscular dystrophy (DMD). Objective: This international, randomized 2 : 1, placebo-controlled, phase 3 study in patients ≥4 – < 8 years old with DMD due to any dystrophin mutation examined the effect of edasalonexent (100 mg/kg/day) compared to placebo over 52 weeks. Methods: Endpoints were changes in the North Star Ambulatory Assessment (NSAA; primary) and timed function tests (TFTs; secondary). Assessment of health-related function used the Pediatric Outcomes Data Collection tool (PODCI). Results: One hundred thirty one patients received edasalonexent (n = 88) and placebo (n = 43). At week 52, differences between edasalonexent and placebo for NSAA total score and TFTs were not statistically significant, although there were consistently less functional declines in the edasalonexent group. A pre-specified analysis by age demonstrated that younger patients (≤6.0 years) showed more robust and statistically significant differences between edasalonexent and placebo for some assessments. Treatment was well-tolerated and the majority of adverse events were mild, and most commonly involved the gastrointestinal system (primarily diarrhea). Conclusions: Edasalonexent was generally well-tolerated with a manageable safety profile at the dose of 100 mg/kg/day. Although edasalonexent did not achieve statistical significance for improvement in primary and secondary functional endpoints for assessment of DMD, subgroup analysis suggested that edasalonexent may slow disease progression if initiated before 6 years of age. (NCT03703882)

104

News (Medical) associated with Astria Therapeutics, Inc.

21 Oct 2024

·www.biospace.com

Astria Therapeutics to Present at Upcoming American College of Allergy, Asthma, and Immunology Annual Scientific Meeting

BOSTON--(BUSINESS WIRE)-- Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced that leading HAE experts will present two posters at the American College of Allergy, Asthma, and Immunology (ACAAI) Annual Scientific Meeting in Boston, Massachusetts on October 25, 2024. Dr. Aleena Banerji, M.D., Associate Professor of Medicine at Harvard Medical School and Clinical Director of the Allergy and Immunology Unit at Massachusetts General Hospital, will present new quality of life data from initial results from the Phase 1b/2 trial of navenibart (STAR-0215) in a presentation of a poster titled “STAR-0215 Induces Rapid Improvements of Quality of Life in HAE Patients in the ALPHA-STAR Trial.” The presentation will take place in Exhibit Hall A on Friday, October 25 at 3:30pm EST. Astria sponsored additional quality of life research in people living with HAE that will be presented by Dr. Donald Levy, M.D., Health Sciences Professor of Medicine in the Division of Basic and Clinical Immunology at the University of California at Irvine. Dr. Levy will present a poster titled “Quality of Life and Burden of Disease in Patients with Hereditary Angioedema and their Caregivers” in Exhibit Hall A on Friday, October 25 at 3:45pm EST. 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, , or follow us on X and Instagram @AstriaTx and on Facebook and LinkedIn. Contacts Astria: Investor Relations and Media: Elizabeth Higgins investors@astriatx.com

ImmunotherapyClinical StudyAACR

27 Sep 2024

·www.biospace.com

Astria Therapeutics to Present at Upcoming Global Angioedema Forum

BOSTON--(BUSINESS WIRE)-- Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced that leading HAE experts will present two posters at the Global Angioedema Forum (GAF) in Copenhagen, Denmark on October 4-5, 2024. Dr. Aleena Banerji, M.D., Associate Professor of Medicine at Harvard Medical School and Clinical Director of the Allergy and Immunology Unit at Massachusetts General Hospital, will present information on ALPHA-SOLAR, a long-term open-label trial of navenibart (STAR-0215) in people living with HAE, in an encore presentation of a poster titled “Rationale and Design of the ALPHA-SOLAR Clinical Trial of STAR-0215.” The poster session will take place on Friday, October 4 at 6:00pm CEST. Dr. William Lumry, M.D., Clinical Professor of Internal Medicine at the University of Texas Health Science Center at Dallas, will present results from the Phase 1b/2 trial of navenibart (STAR-0215) in an encore presentation of a poster titled “ALPHA-STAR, a Phase 1b/2 Clinical Trial of Single and Multiple Doses of STAR-0215 in Patients with Hereditary Angioedema: Initial Safety and Efficacy Outcomes.” The presentation will take place during a session titled “Emerging Treatment Options” on Saturday, October 5 at 9:30am CEST. 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, , or follow us on X and Instagram @AstriaTx and on Facebook and LinkedIn. Contacts Astria Contact: Investor Relations and Media: Elizabeth Higgins investors@astriatx.com

Clinical Study

30 Aug 2024

·www.businesswire.com

Astria Therapeutics to Present at Upcoming Bradykinin Symposium

BOSTON--( BUSINESS WIRE )-- Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced that it will present two posters at the upcoming Bradykinin Symposium in Berlin, Germany on September 6, 2024. Chris Morabito, M.D., Chief Medical Officer at Astria Therapeutics, will present information on ALPHA-SOLAR, a long-term open-label trial of navenibart (STAR-0215) in people living with HAE, in an encore presentation of a poster titled “Rationale and Design of the ALPHA-SOLAR Clinical Trial of STAR-0215.” Kusumam Joseph, Senior Director of Medical Affairs at Astria Therapeutics, will present results from the Phase 1a trial of navenibart (STAR-0215) in an encore presentation of a poster titled “Phase 1a Trial of STAR-0215 for Hereditary Angioedema: Updated Results.” Both posters will be presented at the poster session on Friday, September 6, at 3:35pm CEST. 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 X and Instagram @AstriaTx and on Facebook and LinkedIn.

Phase 1Phase 2Immunotherapy

100 Deals associated with Astria Therapeutics, Inc.

100 Translational Medicine associated with Astria Therapeutics, Inc.

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Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Navenibart ( KLKB1 )	Hereditary Angioedema More	Phase 2
Autophagy stimulants(Astria Therapeutics, Inc)	Cystic Fibrosis More	Preclinical
STAR-0310 ( OX40 )	Dermatitis, Atopic More	Preclinical
CAT-1041 ( NF-κB )	Muscular Dystrophy, Duchenne More	Preclinical
Edasalonexent ( NF-κB )	Muscular Dystrophy, Duchenne More	Discontinued

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