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.

开始日期2023-09-26

申办/合作机构

Astria Therapeutics, Inc.

NCT05695248 / Active, not recruiting临床1/2期

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.

开始日期2023-02-21

申办/合作机构

Astria Therapeutics, Inc.

NCT05477160 / Completed临床1期

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.

开始日期2022-07-27

申办/合作机构

Astria Therapeutics, Inc.

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项与 Navenibart 相关的文献（医药）

2024-03-03·Expert opinion on investigational drugs

Kallikrein inhibitors for angioedema: the progress of preclinical and early phase studies

Review

作者: Farkas, Henriette ; Balla, Zsuzsanna

INTRODUCTION:

Hereditary angioedema (HAE) is a rare genetic disorder characterized by recurrent edema and predominantly caused by the dysregulation of the kinin-kallikrein system.

AREAS COVERED:

This manuscript presents the results of preclinical and early clinical trials of newer drugs targeting the dysregulated kinin-kallikrein system. ATN-249 is an oral drug that has shown promising results in preclinical and Phase I studies, and good tolerability in the prophylactic treatment of attacks. KVD900 is also an oral agent developed for the on-demand treatment of HAE attacks. It has shown positive results in Phase I/II studies, with rapid absorption. The third drug, IONIS-PKKRx, is an antisense oligonucleotide targeting plasma prekallikrein mRNA. It has shown a dose-dependent reduction of plasma prekallikrein levels and proenzyme activation in Phase I/II studies, and has shown promising results. STAR-0215 is a long acting anti-activated kallikrein monoclonal antibody. A Phase 1a single ascending dose trial evaluated its safety, pharmacokinetics, and pharmacodynamics. Lastly, NTLA-2002 is an investigational gene-editing therapy.

EXPERT OPINION:

The targeted treatment of the dysregulated kinin-kallikrein system with specific inhibitors is promising for the prevention of angioedema attacks. Ongoing phase III studies will provide further insight into the efficacy and long-term safety of these novel therapies, potentially expanding treatment options for HAE treatment.

2023-11-01·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

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

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.

项与 Navenibart 相关的新闻（医药）

2024-09-27

·BioSpace

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

临床研究

2024-08-30

·Business Wire

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.

临床1期临床2期免疫疗法

2024-08-13

·Pharmaceutical Technology

Astria Therapeutics taps Ypsomed’s autoinjector for hereditary angioedema drug delivery

A patient with hereditary angioedema (HAE). Image credit: Velimir Zeland / Shutterstock. Astria Therapeutics has selected Ypsomed’s Ypsomate autoinjector as its partner for the administration of STAR-0215 for the treatment of hereditary angioedema (HAE). US-based Astria’s lead candidate, STAR-0215, is a long-acting monoclonal antibody inhibitor of plasma kallikrein for the treatment of HAE. It received fast track designation from the US Food and Drug Administration (FDA) last year and is currently under evaluation in its Phase Ib/II ALPHA-STAR trial (NCT05695248). HAE is a rare genetic disorder. Caused by low levels or the improper functioning of the C1 inhibitor protein, it causes recurrent bouts of severe swelling in patients. Initial proof-of-concept results from the ALPHA-STAR trial were shared in March 2024 and showed that STAR-0215 dosed once or twice over six months reduced monthly HAE attack rates by 90%-96%. Swiss medtech Ypsomed’s Ypsomate autoinjector comes in several size variants for the self-administration of liquid medications. See Also: NorthStar and Convergent expand deal for prostate cancer drug Baxter signs over kidney care arm to investment firm in $3.5bn deal Pending regulatory approval, Astria said it plans to launch STAR-0215 with the Ypsomed YpsoMate autoinjector and a pre-filled syringe, the aim being to develop an HAE therapy that allows patients to choose an approach that works best for their lives with the option of infrequent three- and six-month administration. John Ruesch, senior vice president of pharmaceutical sciences and technical operations at Astria, said: “Our partnership with Ypsomed, a leading developer and manufacturer of injection systems, supports this goal through the planned development of an autoinjector that enables our vision for STAR-0215 to be a therapy that can effectively protect against HAE attacks while also having a very low burden of treatment and administration.” GlobalData’s Clinical Trials database indicates there are around 200 clinical trials in HAE at various stages of active development. In addition, the company’s database indicates there are around 30 pipeline drugs in active development. According to GlobalData, preregistered drugs for HAE have an 85.71% likelihood of approval indication benchmark. GlobalData is the parent company of Pharmaceutical Technology.

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适应症	最高研发状态	国家/地区	公司	日期
遗传性血管性水肿	临床2期	德国	Astria Therapeutics, Inc.	2023-02-21

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05695248 (ALPHA-STAR, Biospace) 人工标引	临床1/2期	遗传性血管性水肿	16	STAR-0215 450 mg (6 months of follow-up)	製積繭糧鹽淵構醖窪製(製齋觸襯獵糧築願鑰餘) = 鹹糧鏇壓獵齋淵構糧膚遞窪獵憲構遞膚鬱糧願 (餘醖蓋齋醖廠窪淵願鏇 ) 更多	积极	2024-03-25
NCT05695248 (ALPHA-STAR, Biospace) 人工标引	临床1/2期	遗传性血管性水肿	16	STAR-0215 600mg+300mg(three months later) (6 months of follow-up)	製積繭糧鹽淵構醖窪製(製齋觸襯獵糧築願鑰餘) = 壓鏇衊範齋憲窪衊積壓遞窪獵憲構遞膚鬱糧願 (餘醖蓋齋醖廠窪淵願鏇 ) 更多	积极	2024-03-25
NCT05477160 (AAAAI2024) 人工标引	临床1期	遗传性血管性水肿 cleaved high-molecular-weight-kininogen (cHMWK)	41	STAR-0215 1200 mg SC	夢憲膚夢鹹鑰衊膚築網(餘構鏇網選窪築網選鹽) = were seen in 10 STAR-0215 and 1 placebo subjects, most commonly injection site reactions (n=9). 遞遞壓齋顧窪齋廠糧鹹 (製憲願衊鏇夢鬱鑰淵憲 ) 更多	积极	2024-02-23
ALPHA-STAR (PipelineReview) 人工标引	临床1期	遗传性血管性水肿	-	STAR-0215	夢獵觸齋觸窪膚醖遞鬱(膚鏇網壓築鏇壓糧憲選) = STAR-0215 was well-tolerated, with no serious adverse events or discontinuations due to an adverse event, and low risk of injection pain 鑰膚蓋齋醖製範鑰廠觸 (壓艱膚淵廠蓋築窪鬱簾 ) 更多	积极	2023-11-10