navenibart (STAR-0215) / Astria Therap, Kaken Pharma - LARVOL DELTA

Final Results From ALPHA-STAR A Phase 1b/2 Trial Of Navenibart In Hereditary Angioedema (ACAAI 2025) - P1/2 | "Conclusion Navenibart robustly and durably decreased the HAE attack rate with a favorable safety profile. Every 3- and 6-month regimens are currently being investigated in a Phase 3 trial (ALPHA-ORBIT, NCT068428)."

Clinical • P1/2 data • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

A Long-Term Study of Navenibart in Participants With Hereditary Angioedema (clinicaltrials.gov) - P3 | N=145 | Enrolling by invitation | Sponsor: Astria Therapeutics, Inc.

New P3 trial • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

Astria Therapeutics Now Enrolling HAE Patients in the European Union for the Phase 3 ALPHA-ORBIT Trial (Businesswire) - "Astria is enrolling the ongoing ALPHA-ORBIT trial with clinical trial sites open and accepting HAE patients across the United States, Europe, United Kingdom, Canada, Hong Kong, South Africa, Japan, North Macedonia, and Israel."

Trial status • Hereditary Angioedema

A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema (clinicaltrials.gov) - P2 | N=56 | Active, not recruiting | Sponsor: Astria Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

Astria Therapeutics Announces Publication of Navenibart Phase 1a Healthy Subject Results in the Annals of Allergy, Asthma & Immunology (Businesswire) - P1a | N=41 | NCT05477160 | Sponsor: Astria Therapeutics, Inc. | "Astria Therapeutics, Inc...announced that results from a Phase 1a trial in healthy subjects supporting navenibart’s potential to provide long-acting, safe, and effective attack prevention for hereditary angioedema (HAE) with dosing every 3 and 6 months have been published in the Annals of Allergy, Asthma & Immunology....Overview of results from the Phase 1a trial of navenibart in healthy subjects: For all doses ≥300 mg, navenibart mean half-life ranged from 82 to 105 days, supporting the potential for administration every 3 and 6 months. Navenibart’s inhibition of plasma kallikrein activity versus placebo was statistically significant (P<0.05); Navenibart was well-tolerated, with similar rates of adverse events between navenibart and placebo, and no serious adverse events were observed; Results demonstrated early proof of concept for navenibart as a potential long-acting therapy for HAE."

P1 data • Hereditary Angioedema

ALPHA-STAR: A Study of STAR-0215 in Participants With Hereditary Angioedema (clinicaltrials.gov) - P1/2 | N=29 | Completed | Sponsor: Astria Therapeutics, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Sep 2025 ➔ Mar 2025 | Trial primary completion date: Sep 2025 ➔ Mar 2025

Trial completion • Trial completion date • Trial primary completion date • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

Safety and Pharmacokinetics of Long-Acting Plasma Kallikrein Inhibitor Navenibart (STAR-0215) in Healthy Adults. (PubMed, Ann Allergy Asthma Immunol) - "In this first-in-human study, up to 1200 mg of navenibart was well tolerated and demonstrated an extended half-life with durable plasma kallikrein inhibition."

Journal • PK/PD data • Cardiovascular • Complement-mediated Rare Disorders • Dermatology • Hereditary Angioedema

ALPHA-ORBIT: A Study of Navenibart in Participants with Hereditary Angioedema (clinicaltrials.gov) - P3 | N=145 | Recruiting | Sponsor: Astria Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

Astria Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Corporate Update (Businesswire) - "Navenibart (STAR-0215): All of the 16 target enrollment patients from ALPHA-STAR have entered the ALPHA-SOLAR long-term open-label trial. Initial safety and efficacy data from ALPHA-SOLAR, with Q3M and Q6M administration, are expected mid-2025."

P2 data • Hereditary Angioedema

ALPHA-ORBIT: A Study of Navenibart in Participants with Hereditary Angioedema (clinicaltrials.gov) - P3 | N=145 | Not yet recruiting | Sponsor: Astria Therapeutics, Inc.

New P3 trial • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

Astria Therapeutics Initiates ALPHA-ORBIT Phase 3 Pivotal Trial of Navenibart in Hereditary Angioedema (Businesswire) - "Astria Therapeutics, Inc...today announced the initiation of the ALPHA-ORBIT Phase 3 clinical trial of navenibart in people living with hereditary angioedema (HAE). Navenibart has the potential to provide rapid and sustained HAE attack prevention with a very low treatment burden and administration every 3 months (Q3M) and every 6 months (Q6M)...Top-line results from the trial are anticipated in early 2027."

P3 data: top line • Trial status • Hereditary Angioedema

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

Results from the ALPHA-STAR Trial, a Phase 1b/2 Single and Multiple Dose Study to Assess the Safety, Tolerability, Clinical Activity, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Navenibart (STAR-0215) in Participants with Hered (AAAAI-WAO 2025) - No abstract available

Clinical • Late-breaking abstract • P1/2 data • PK/PD data

ALPHA-ORBIT - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Adolescent and Adult Participants with Type 1 and Type 2 Hereditary Angioedema (HAE) (AAAAI-WAO 2025) - "Results Navenibart has the potential to offer significant improvement in the clinical care of HAE patients. Conclusions Efficacy and safety of navenibart in the long-term prevention of HAE attacks will be investigated in the randomized, global Phase 3 trial ALPHA-ORBIT."

Clinical • P3 data • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

Treatment with Navenibart (STAR-0215) Reduces Attack Severity and Use of Rescue Medication in Patients with Hereditary Angioedema (HAE): Interim Results from the ALPHA-STAR Trial (AAAAI-WAO 2025) - P1/2 | "Conclusions This interim analysis suggests that navenibart reduces the burden of HAE, assessed by reduction in HAE attack frequency, severity and use of rescue medication. No safety issues were identified."

Clinical • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

Astria Therapeutics to Present at Upcoming Western Society of Allergy, Asthma & Immunology Annual Scientific Session (Businesswire) - "Astria Therapeutics, Inc...today announced that it will present quality of life results from the Phase 1b/2 trial of navenibart (STAR-0215) in a poster displayed at the Western Society of Allergy, Asthma & Immunology (WSAAI) Annual Scientific Session in Waimea, Hawaii from Sunday, February 9 through Thursday, February 13, 2025."

P1/2 data • Hereditary Angioedema

STAR-0215 INDUCES RAPID IMPROVEMENTS OF QUALITY OF LIFE IN HAE PATIENTS IN THE ALPHA-STAR TRIAL (ACAAI 2024) - P1/2 | "Supported by PK, PD, efficacy and safety data over the first 28 days in ALPHA-STAR, STAR-0215 induced rapid improvements in QoL of HAE patients."

Clinical • HEOR • Cardiovascular

A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema (clinicaltrials.gov) - P2 | N=56 | Recruiting | Sponsor: Astria Therapeutics, Inc. | Enrolling by invitation ➔ Recruiting | Trial completion date: Aug 2030 ➔ Mar 2031 | Trial primary completion date: Aug 2030 ➔ Mar 2031

Enrollment status • Trial completion date • Trial primary completion date • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

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 (EADV 2024) - P1/2 | "This initial analysis of the ongoing ALPHA-STAR clinical trial demonstrated that STAR-0215 has a favorable safety profile with reductions in HAE attack frequency and severity. STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein, has the potential to offer effective long-acting prevention of HAE attacks sustained for up to 6 months, supporting progression into Phase 3 to evaluate effectiveness of every 3- and 6-month administration. Figure 1."

Clinical • P1/2 data • Cardiovascular • Complement-mediated Rare Disorders • Gastrointestinal Disorder • Hereditary Angioedema

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 (EADV 2024) - P1/2 | "This initial analysis of the ongoing ALPHA-STAR clinical trial demonstrated that STAR-0215 has a favorable safety profile with reductions in HAE attack frequency and severity. STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein, has the potential to offer effective long-acting prevention of HAE attacks sustained for up to 6 months, supporting progression into Phase 3 to evaluate effectiveness of every 3- and 6-month administration. Figure 1."

Clinical • P1/2 data • Cardiovascular • Complement-mediated Rare Disorders • Gastrointestinal Disorder • Hereditary Angioedema

Astria Therapeutics Receives FDA Orphan Drug Designation for Navenibart (STAR-0215) for the Treatment of Hereditary Angioedema (Businesswire) - "Astria Therapeutics, Inc...announced that navenibart (STAR-0215) has been granted Orphan Drug Designation for the treatment of hereditary angioedema (HAE) by the U.S. Food and Drug Administration (FDA)....Initial results from the Phase 1b/2 ALPHA-STAR clinical trial of navenibart have demonstrated a favorable safety and tolerability profile and a reduction of monthly attack rates by 90-96% when dosed once or twice over six months....'We expect to share additional results from the ALPHA-STAR trial in Q4 and to progress navenibart into a Phase 3 trial initiating in the first quarter of 2025.'"

New P3 trial • Orphan drug • P1/2 data • Genetic Disorders • Hereditary Angioedema

ALPHA-STAR: A Study of STAR-0215 in Participants With Hereditary Angioedema (clinicaltrials.gov) - P1/2 | N=28 | Active, not recruiting | Sponsor: Astria Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

Astria Therapeutics to Present at Upcoming Eastern Allergy Conference (Yahoo Finance) - "Astria Therapeutics, Inc...today announced that it will present final STAR-0215 Phase 1a healthy subject data in an encore presentation at the upcoming Eastern Allergy Conference in Palm Beach, Florida on June 1, 2024."

P1 data • Genetic Disorders • Hereditary Angioedema

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

Kallikrein inhibitors for angioedema: the progress of preclinical and early phase studies. (PubMed, Expert Opin Investig Drugs) - "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...The third drug, IONIS-PKKRx, is an antisense oligonucleotide targeting plasma prekallikrein mRNA...STAR-0215 is a long acting anti-activated kallikrein monoclonal antibody...Lastly, NTLA-2002 is an investigational gene-editing therapy. 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."

Journal • Preclinical • Review • Cardiovascular • Complement-mediated Rare Disorders • Genetic Disorders • Hereditary Angioedema