Astoria Therapeutics Launches ALPHA-ORBIT Phase 3 Trial for Navenivart in Hereditary Angioedema
Astoria Therapeutics, a biopharmaceutical company focused on developing breakthrough therapies for allergy and immunology disorders, has announced the initiation of the ALPHA-ORBIT trial, a pivotal Phase 3 clinical study aimed at evaluating the efficacy and safety of navenivart for treating hereditary angioedema (HAE). This clinical trial will assess the potential of navenivart, a treatment designed to provide rapid and sustained prevention of HAE attacks, with minimal patient burden.
The Promise of Navenivart
Navenivart, administered at intervals of either every three months (Q3M) or every six months (Q6M), offers a promising new approach to managing hereditary angioedema. HAE is a rare and potentially life-threatening genetic disorder characterized by recurrent episodes of severe swelling, often affecting the face, throat, and airways, which can result in significant pain, discomfort, and in extreme cases, suffocation.
Christopher Morabito, Chief Medical Officer at Astoria Therapeutics, expressed enthusiasm about the trial, stating, “We believe navenivart offers high efficacy, low treatment burden, and good safety and tolerability, and we are excited to initiate the Phase 3 ALPHA-ORBIT study to support that vision. The Phase 3 program is designed to provide choice, allowing patients and their physicians to decide which treatment is best for them, with navenivart administered just two or four times a year.”
This flexible dosing regimen, combined with the potential for rapid and lasting attack prevention, could transform the way healthcare providers manage HAE, offering patients an improved quality of life with fewer treatment disruptions.
Navenivart’s Potential Impact on HAE Patients
Currently, many patients with HAE face the burden of frequent treatments, often requiring injections or infusions multiple times a month. These treatments are necessary to prevent attacks and manage the symptoms of the disorder. However, navenivart’s novel dosing schedule allows for longer intervals between treatments, which could help reduce the inconvenience and stress associated with regular treatments.
Arena Banerji, clinical director of the MGH Allergy and Immunology Unit and principal investigator of the ALPHA-ORBIT trial, highlighted the potential of navenivart to change the lives of HAE patients: “Patients would greatly benefit from a treatment that would enable them to live free from the limitations of HAE. Navenivart has shown the potential to prevent HAE attacks at lower doses, potentially reducing the time patients spend in treatment.”
This represents a significant advancement for HAE patients, as it could reduce both the frequency and intensity of attacks, allowing individuals to lead more normal, unrestricted lives.
The ALPHA-ORBIT Trial: Design and Goals
The ALPHA-ORBIT trial is a global, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of navenivart in patients with HAE. The trial will include 135 adult participants and 10 adolescents (who will be part of an open-label arm), all diagnosed with either type 1 or type 2 HAE. The goal is to assess the effects of navenivart over a six-month treatment period.
In the trial, adult patients will be randomly assigned to one of three dose arms:
- Loading dose of 600 mg followed by 300 mg every three months.
- 600 mg every six months.
- 600 mg every three months, or placebo.
The adolescent participants will receive a loading dose of 600 mg followed by 300 mg every three months.
This flexible dosing approach provides patients with options based on their needs and the frequency of treatment that best suits their lifestyle.
The primary endpoint of the study is the time-standardized monthly rate of HAE attacks over six months. Secondary endpoints include the proportion of participants who are attack-free at six months, providing insight into the treatment’s long-term potential for preventing attacks.
Topline results from the ALPHA-ORBIT trial are expected in early 2027, which will give valuable insights into the drug’s performance.
The Follow-up Study: ORBIT-EXPANSE
Following the six-month ALPHA-ORBIT study, patients may be eligible to participate in an ongoing long-term study called ORBIT-EXPANSE. In this study, all patients will receive treatment with navenivart, but the duration of treatment will be flexible, tailored to each patient’s needs.
The ORBIT-EXPANSE study is designed to further evaluate the long-term safety and efficacy of navenivart in real-world settings, providing crucial information on the treatment’s impact over extended periods.
Building on Phase 1b/2 ALPHA-STAR Results
The ALPHA-ORBIT Phase 3 trial is built upon the success of the Phase 1b/2 ALPHA-STAR study, which demonstrated promising results for navenivart in treating HAE. The Phase 1b/2 trial showed rapid onset and sustained efficacy, with 90-95% reductions in the average monthly rate of HAE attacks, and up to 67% of patients achieving attack freedom after six months of treatment.
The data from the ALPHA-STAR trial confirmed the strong safety and tolerability profile of navenivart, reinforcing its potential as a game-changing treatment for patients with HAE. The positive results from ALPHA-STAR have laid a solid foundation for the Phase 3 ALPHA-ORBIT study, which will further validate navenivart’s potential to improve patient outcomes.
Astoria Therapeutics Launches ALPHA-ORBIT Phase 3 Trial for Navenivart in Hereditary Angioedema
What’s Next for Astoria Therapeutics
Astoria Therapeutics is committed to advancing navenivart through clinical development to bring an innovative solution to patients with HAE. The Phase 3 program, including the ALPHA-ORBIT and ORBIT-EXPANSE studies, is a critical step toward achieving this goal.
As the company moves forward, it is focused on providing patients and healthcare providers with a treatment that minimizes the burden of HAE while offering superior attack prevention. With a focus on flexible dosing, low treatment burden, and high efficacy, Astoria is poised to make a significant impact in the lives of those affected by hereditary angioedema.
In the meantime, patients and physicians await the results of the ALPHA-ORBIT trial, which could mark a new era in HAE treatment. As the topline results are anticipated in early 2027, the future of navenivart looks promising, with the potential to transform how hereditary angioedema is managed and treated globally.
Conclusion
Astoria Therapeutics’ launch of the ALPHA-ORBIT Phase 3 trial for navenivart represents a pivotal moment in the development of treatments for hereditary angioedema. With its innovative dosing regimen and strong efficacy data, navenivart has the potential to significantly improve the quality of life for HAE patients worldwide. The ongoing research and future results will likely play a crucial role in shaping the treatment landscape for this rare and often debilitating condition.
About Naveen Baat:
Navenivrt is an investigational monoclonal antibody blocking plasma kallikrein that is in Phase 3 development for the treatment of HAE. The goal is to rapidly and sustainably prevent HAE attacks with a proven mechanism and reliable method of administering Navenivrt every 3 and 6 months, allowing HAE patients to live life free from the limitations of their disease.
About Astoria Therapeutics
Astoria Therapeutics is a biopharmaceutical company whose mission is to bring life-changing therapies to patients and their families suffering from allergy and immune-related disorders. The company’s lead program, navenivart (STAR-0215), is a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema. Its second program, STAR-0310, is a monoclonal antibody OX40 antagonist in clinical development for the treatment of atopic dermatitis.
To learn more about Astoria Therapeutics, please visit the company’s website at www.astriatx.com or follow us on Instagram @AstriaTx, Facebook and LinkedIn.
For more information on the ALPHA-ORBIT Phase 3 trial,
please visit
AlphaOrbit.longboat.com , astriatrials.com or clinicaltrials.gov ,
