Astria Therapeutics Launches Phase 3 ALPHA-ORBIT Trial of Navenibart for Hereditary Angioedema
Astria Therapeutics, Inc. (Nasdaq: ATXS), a biopharmaceutical company dedicated to developing transformative therapies for allergic and immune diseases, has announced the launch of the Phase 3 ALPHA-ORBIT clinical trial for Navenibart, a treatment for hereditary angioedema (HAE). Navenibart aims to offer a rapid and long-lasting prevention of HAE attacks, with the added benefit of minimal treatment burden, requiring dosing only every three to six months.
Astria Therapeutics, Inc. (Nasdaq: ATXS), a biopharmaceutical company dedicated to developing innovative therapies for allergic and immune diseases, has officially launched the Phase 3 ALPHA-ORBIT clinical trial for Navenibart, a promising treatment for hereditary angioedema (HAE). Navenibart has shown significant potential in preventing HAE attacks with minimal treatment burden, offering dosing intervals of just every three to six months. This trial is a crucial step in advancing the treatment options for HAE patients, allowing them to potentially receive treatment only two or four times per year.
“We believe that Navenibart has strong efficacy, low treatment burden, and good safety and tolerability, and we are excited to initiate the ALPHA-ORBIT Phase 3 trial to help realize this vision,” said Christopher Morabito, MD, Chief Medical Officer of Astria Therapeutics. “The Phase 3 trial is designed to provide more options, allowing patients and physicians to decide the treatment option that best suits them, with the flexibility of dosing only twice or four times a year.”
Patients living with hereditary angioedema face frequent and unpredictable attacks, which can be debilitating and impact their quality of life. Current treatment options often require more frequent dosing, placing a significant burden on patients. The ALPHA-ORBIT trial represents a potential breakthrough, offering a new therapy that could drastically reduce this burden while still providing highly effective attack prevention.
Aleena Banerji, MD, principal investigator of the ALPHA-ORBIT trial and clinical director of the Allergy and Immunology Group at Massachusetts General Hospital (MGH), emphasized the importance of Navenibart’s ability to improve the lives of patients. “We’ve heard from patients that a therapy that allows them to live their lives without the constraints of HAE would be very meaningful to them,” said Dr. Banerji. “Navenibart has demonstrated that it is possible to prevent HAE attacks by taking fewer medications, giving patients the freedom to spend less time dealing with their illness.”
The ALPHA-ORBIT trial is a global, randomized, double-blind, placebo-controlled pivotal Phase 3 clinical study. It is designed to evaluate the safety and efficacy of Navenibart in 135 adult patients and 10 adolescent patients (open-label) with HAE types 1 or 2. The treatment period for the trial will last for six months. Adult patients will be randomized to receive one of three Navenibart dosing regimens: 1) an initial dose of 600 mg followed by 300 mg every 3 months, 2) 600 mg every 6 months, or 3) 600 mg every 3 months or placebo. Adolescent patients will receive an initial dose of 600 mg followed by 300 mg every 3 months.
The goal of the study is to provide patient-centered, flexible dosing options that can be tailored to the needs of HAE patients. The primary endpoint of the trial is to assess the normalization of the time to monthly HAE attacks over the course of six months. Secondary endpoints will include the proportion of participants who are attack-free after six months. Preliminary results from the trial are expected in early 2027.
Following the six-month treatment period, patients may transition into a long-term extension trial called ORBIT-EXPANSE, where all participants will receive Navenibart. This long-term study will continue to investigate the flexibility and efficacy of Navenibart with a patient-centric approach, allowing for individualized treatment options.
The Phase 3 program builds upon the positive results of the earlier Phase 1b/2 ALPHA-STAR trial, which showed that Navenibart was effective at significantly reducing HAE attacks. The trial demonstrated that Navenibart could reduce the average monthly attack rate by 90-95%, with a 67% attack-free rate within six months. These results highlighted Navenibart’s potential to offer substantial and lasting efficacy, with excellent safety, tolerability, and pharmacokinetics that support sustained inhibition of plasma kallikrein, a key enzyme involved in HAE attacks.
The success of the ALPHA-STAR trial has set a strong foundation for the ongoing Phase 3 clinical program, and Astria Therapeutics is optimistic about the future potential of Navenibart in improving the lives of HAE patients worldwide.
The ALPHA-ORBIT Phase 3 trial is open to global enrollment, and for more information, interested parties can visit AlphaOrbit.longboat.com, astriatrials.com, or clinicaltrials.gov (NCT06842823).
In conclusion, Astria Therapeutics is committed to advancing innovative treatments for HAE and other allergic and immune diseases. The ALPHA-ORBIT Phase 3 trial represents an important milestone in the development of Navenibart, which holds the potential to transform the standard of care for HAE patients, providing them with a more flexible and effective treatment option for managing their condition.
