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 --
“We are thrilled to share positive initial results from the ALPHA-SOLAR long-term open-label trial,” said
“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.
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
In
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
Forward Looking Statements:
This press release contains forward-looking statements within the meaning of applicable securities laws and regulations including, but not limited to, statements regarding: our expectations regarding the potential significance of the results from the navenibart Phase 1b/2 ALPHA-STAR clinical trial and initial results from the ALPHA-SOLAR trial; the goals and objectives of the ALPHA-ORBIT trial; the potential therapeutic benefits of navenibart as a treatment for HAE; the potential attributes and profile of navenibart as a treatment for HAE, including its potential to be a life-changing, market leading preventative treatment for HAE, and our overall vision and goals for the navenibart program; and our corporate strategy and vision, including our mission is to bring life-changing therapies to patients and families affected by allergic and immunologic diseases. The use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “goals,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or "vision," and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Astria’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, future financial performance, results of pre-clinical and clinical results of the Astria’s product candidates and other future conditions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties related to: changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business, and/or competitive factors; risks inherent in pharmaceutical research and development, such as: adverse results in our drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies may not be replicated in clinical trials, that the preliminary, initial or interim results from clinical trials may not be indicative of the final results, that the results of early stage clinical trials, such as the results from the ALPHA-STAR Phase 1b/2 clinical trial, may not be replicated in later stage clinical trials, such as the planned Phase 3 development program, the risk that we may not be able to enroll sufficient patients in our clinical trials on a timely basis, and the risk that any of our clinical trials may not commence, continue or be completed on time, or at all; decisions made by, and feedback received from, the
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