Astria Therapeutics Announces Positive Initial Results from the ALPHA-SOLAR Long-Term Open-Label Trial of Navenibart in Hereditary Angioedema Patients at the European Academy of Allergy and Clinical Immunology Annual Congress
— Q3M Arm Demonstrated 95% Mean Monthly Attack-Rate Reduction —
— Q6M Arm Demonstrated 86% Mean Monthly Attack-Rate Reduction –
— Well-Tolerated with a Favorable Safety Profile —
— All Patients Remain on Navenibart —
— Long-Term Data are Highly Consistent with Previous Results and Support the Potential Market-Leading Profile of Navenibart, Administered 2 or 4 Times Per Year —
— Phase 3 ALPHA-ORBIT Trial Underway and Enrolling Patients —
BOSTON, MA, USA I June 13, 2025 IAstria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced positive initial results from the target enrollment group in the ongoing ALPHA-SOLAR long-term open-label trial evaluating navenibart (STAR-0215), a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema (HAE) patients. These results demonstrated robust overall reduction in the monthly attack rate (92% mean and 97% median). These results further support navenibart’s favorable safety and tolerability profile, and potential every three- (Q3M) and every six-month (Q6M) dosing regimens.
“We are thrilled to share positive initial results from the ALPHA-SOLAR long-term open-label trial,” said Christopher Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “Results are consistent with navenibart’s best-in-class profile that we saw in the ALPHA-STAR Phase 1b/2 trial. With now 12 to 18 months on navenibart, these ALPHA-SOLAR results support navenibart’s favorable profile and the potential to administer navenibart every 3 and every 6 months. The Phase 3 ALPHA-ORBIT trial is evaluating both every 3- and every 6-month regimens and is actively enrolling patients. Navenibart’s profile and results that we have seen to date demonstrate the potential for navenibart to be the market-leading HAE therapy.”
“The navenibart results in patients to date support the potential for patients to have long-acting protection from their HAE attacks with very low treatment burden,” said Dr. William Yang, M.D., PRCPC, FAAAAI, Chair, Ottawa Allergy Research Corporation and Red Maple Trials Inc. “We are excited for the Phase 3 ALPHA-ORBIT trial and believe that navenibart’s profile with infrequent dosing could allow patients to spend less time thinking about their HAE, and more time living their lives.”
ALPHA-SOLAR is a long-term open-label trial in adults with HAE Type 1 or 2 designed to assess long-term safety and efficacy of navenibart. All 16 target enrollment participants from the Phase 1b/2 ALPHA-STAR trial elected to enroll in ALPHA-SOLAR. ALPHA-STAR patients from Cohorts 1 and 2 enrolled in Arm A, and ALPHA-STAR patients from Cohort 3 enrolled in Arm B (described in the table below).
Initial results from ALPHA-SOLAR1:
Mean / Median Reduction in Monthly Attack Rate
Mean / Median Reduction in Moderate and Severe Monthly Attack Rate
Mean / Median Reduction in Monthly Rate of Attacks Treated with On Demand Medication
Overall (n=16, 10.1 mean / 9.1 median months of follow-up)
92% / 97%
95% / 100%
92% / 98%
Arm A 600 mg / 300 mg Q3M (n=10, 11.3 mean / 9.3 median months of follow-up)
95% / 99%
96% / 100%
95% / 98%
Arm B 600 mg / 600 mg at Day 28, 600 mg Q6M (n=6, 8 mean / 7.4 median months of follow-up)
86% / 90%
90% / 94%
87% / 95%
Comparisons to baseline from ALPHA-STAR.
Navenibart demonstrated overall attack-freedom of 50% over six months, which is the longest period of follow-up for all 16 patients to date. All patients remain in the ALPHA-SOLAR trial. Navenibart was well-tolerated with no severe or serious treatment-emergent adverse events (TEAEs) and no discontinuations. One participant experienced two treatment-related, mild injection site reactions that resolved without treatment. There were no injection site reactions of pain. The safety profile of navenibart in patients with HAE was favorable through more than 17 months (median / mean) of cumulative follow-up since the initiation of navenibart in ALPHA-STAR.
The results shared above are available in a poster presented at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress on June 13, 2025. The poster is accessible to conference attendees and also in the Scientific Presentations and Publications section of www.astriatx.com.
In February 2025, Astria initiated the pivotal Phase 3 ALPHA-ORBIT trial, which is evaluating navenibart administered Q3M and Q6M and currently enrolling patients. For more information, visit clinicaltrials.gov, NCT06842823 or alphaorbit.longboat.com.
About Navenibart:
Navenibart is a monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of HAE. Our goal with navenibart is to provide rapid and sustained HAE attack prevention with a validated mechanism and trusted modality administered subcutaneously every 3 and 6 months. We aim to empower people living with HAE to live life without limitations from their disease.
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 Instagram @AstriaTx and on Facebook and LinkedIn.
— Q3M Arm Demonstrated 95% Mean Monthly Attack-Rate Reduction —
— Q6M Arm Demonstrated 86% Mean Monthly Attack-Rate Reduction –
— Well-Tolerated with a Favorable Safety Profile —
— All Patients Remain on Navenibart —
— Long-Term Data are Highly Consistent with Previous Results and Support the Potential Market-Leading Profile of Navenibart, Administered 2 or 4 Times Per Year —
— Phase 3 ALPHA-ORBIT Trial Underway and Enrolling Patients —
BOSTON, MA, USA I June 13, 2025 IAstria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced positive initial results from the target enrollment group in the ongoing ALPHA-SOLAR long-term open-label trial evaluating navenibart (STAR-0215), a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema (HAE) patients. These results demonstrated robust overall reduction in the monthly attack rate (92% mean and 97% median). These results further support navenibart’s favorable safety and tolerability profile, and potential every three- (Q3M) and every six-month (Q6M) dosing regimens.
“We are thrilled to share positive initial results from the ALPHA-SOLAR long-term open-label trial,” said Christopher Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “Results are consistent with navenibart’s best-in-class profile that we saw in the ALPHA-STAR Phase 1b/2 trial. With now 12 to 18 months on navenibart, these ALPHA-SOLAR results support navenibart’s favorable profile and the potential to administer navenibart every 3 and every 6 months. The Phase 3 ALPHA-ORBIT trial is evaluating both every 3- and every 6-month regimens and is actively enrolling patients. Navenibart’s profile and results that we have seen to date demonstrate the potential for navenibart to be the market-leading HAE therapy.”
“The navenibart results in patients to date support the potential for patients to have long-acting protection from their HAE attacks with very low treatment burden,” said Dr. William Yang, M.D., PRCPC, FAAAAI, Chair, Ottawa Allergy Research Corporation and Red Maple Trials Inc. “We are excited for the Phase 3 ALPHA-ORBIT trial and believe that navenibart’s profile with infrequent dosing could allow patients to spend less time thinking about their HAE, and more time living their lives.”
ALPHA-SOLAR is a long-term open-label trial in adults with HAE Type 1 or 2 designed to assess long-term safety and efficacy of navenibart. All 16 target enrollment participants from the Phase 1b/2 ALPHA-STAR trial elected to enroll in ALPHA-SOLAR. ALPHA-STAR patients from Cohorts 1 and 2 enrolled in Arm A, and ALPHA-STAR patients from Cohort 3 enrolled in Arm B (described in the table below).
Initial results from ALPHA-SOLAR1:
Mean / Median Reduction in Monthly Attack Rate
Mean / Median Reduction in Moderate and Severe Monthly Attack Rate
Mean / Median Reduction in Monthly Rate of Attacks Treated with On Demand Medication
Overall (n=16, 10.1 mean / 9.1 median months of follow-up)
92% / 97%
95% / 100%
92% / 98%
Arm A 600 mg / 300 mg Q3M (n=10, 11.3 mean / 9.3 median months of follow-up)
95% / 99%
96% / 100%
95% / 98%
Arm B 600 mg / 600 mg at Day 28, 600 mg Q6M (n=6, 8 mean / 7.4 median months of follow-up)
86% / 90%
90% / 94%
87% / 95%
Comparisons to baseline from ALPHA-STAR.
Navenibart demonstrated overall attack-freedom of 50% over six months, which is the longest period of follow-up for all 16 patients to date. All patients remain in the ALPHA-SOLAR trial. Navenibart was well-tolerated with no severe or serious treatment-emergent adverse events (TEAEs) and no discontinuations. One participant experienced two treatment-related, mild injection site reactions that resolved without treatment. There were no injection site reactions of pain. The safety profile of navenibart in patients with HAE was favorable through more than 17 months (median / mean) of cumulative follow-up since the initiation of navenibart in ALPHA-STAR.
The results shared above are available in a poster presented at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress on June 13, 2025. The poster is accessible to conference attendees and also in the Scientific Presentations and Publications section of www.astriatx.com.
In February 2025, Astria initiated the pivotal Phase 3 ALPHA-ORBIT trial, which is evaluating navenibart administered Q3M and Q6M and currently enrolling patients. For more information, visit clinicaltrials.gov, NCT06842823 or alphaorbit.longboat.com.
About Navenibart:
Navenibart is a monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of HAE. Our goal with navenibart is to provide rapid and sustained HAE attack prevention with a validated mechanism and trusted modality administered subcutaneously every 3 and 6 months. We aim to empower people living with HAE to live life without limitations from their disease.
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 Instagram @AstriaTx and on Facebook and LinkedIn.
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