— Navenibart Demonstrated 6 Months of HAE Attack Prevention with 1 or 2 Doses —
— 90-95% Mean Monthly Attack Rate Reduction Supporting Chronic Dosing 2 or 4 Times Per Year —
— 67% Attack-Free Rate Over 6 Months in Cohorts 2 and 3 —
— Favorable Safety and Well-Tolerated Profile —
— Phase 3 Initiation on Track for Q1 2025 —
BOSTON, MA, USA I December 11, 2024 I Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced positive final results from the target enrollment group of 16 patients in the ALPHA-STAR Phase 1b/2 clinical trial evaluating navenibart (STAR-0215), a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema (HAE) patients. These final results demonstrated reduction in the mean monthly attack rate of 90-95% at 6 months, favorable safety and tolerability profile, and support both every three- (Q3M) and every six-month (Q6M) dosing regimens. The results underscore the potential of navenibart’s profile to be the market-leading therapy for HAE. Astria is advancing navenibart to Phase 3 development with trial initiation expected in Q1 2025.
“The results from the ALPHA-STAR Phase 1b/2 trial affirm our belief in navenibart’s profile and its potential to be a life-changing, market-leading preventative treatment for HAE patients,” said Christopher Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “After one or two doses over six months, patients experienced rapid onset of robust and durable efficacy, favorable safety and tolerability, and PK and PD that are consistent with sustained plasma kallikrein inhibition and Q3M and Q6M administration. These results are highly consistent with the interim results we reported in March. We look forward to presenting these data at an upcoming scientific conference and expect to initiate Phase 3 development in Q1, pending completion of discussions with global regulators.”
“These results from the ALPHA-STAR trial are exciting for the future of the HAE treatment landscape,” said Dr. Aleena Banerji, Clinical Director MGH Allergy and Clinical Immunology Unit. “We understand from people living with HAE that the disease and treatment burden can weigh heavily on their physical and mental health. I am optimistic that a therapy with infrequent dosing, a well-tolerated profile, and a trusted mechanism and modality could alleviate the burden for patients.”
ALPHA-STAR is a dose-ranging proof-of-concept trial in adults with HAE Type 1 or 2 designed to assess safety, tolerability, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and quality of life in patients receiving single and multiple doses of navenibart in three cohorts delivered subcutaneously to prevent attacks in HAE. All cohorts began with an eight-week run-in period to measure baseline HAE attacks and safety, efficacy, PK, and PD are assessed through 6-months (Day 168) after the last dose received. Among the target enrollment (n=16), 88% had Type 1 HAE, the average age was 46 years, and 56% were female.
Cohort 1 evaluated a 450 mg dose (n=4). Results show that, on average, over 6 months:
- 91% reduction in monthly attack rate
- 96% reduction in moderate and severe attacks
- 94% reduction in acute rescue medication use
- 50% of patients were attack-free through 3 months of follow-up, and 25% were attack-free through 6 months of follow-up
Cohort 2 evaluated a 600 mg dose followed by a 300 mg dose three months later (n=6). Results show that, on average, over 6 months:
- 95% reduction in monthly attack rate
- 95% reduction in moderate and severe attacks
- 94% reduction in acute rescue medication use
- 67% of patients were attack-free
Cohort 3 evaluated a 600 mg dose followed by a 600 mg dose one month later (n=6). Results show that, on average, over 6 months:
- 92% reduction in monthly attack rate
- 96% reduction in moderate and severe attacks
- 91% reduction in acute rescue medication use
- 67% of patients were attack-free
PK and PD were consistent with previously reported results and demonstrated rapid and sustained target plasma kallikrein inhibition consistent with effective and safe Q3M and Q6M administration.
Navenibart was generally well-tolerated with no serious treatment-emergent adverse events (TEAEs) and no discontinuations. There were four non-severe and quickly resolved treatment-related TEAEs: one case of dizziness, a transient injection site reaction (rash), an injection site erythema, and an injection site pruritus. There were no injection site reactions of pain.
The results shared above are available in the Company’s corporate presentation in the investor section of www.astriatx.com. The Company expects to present these data at an upcoming scientific conference.
All 16 patients have enrolled into ALPHA-SOLAR, a long-term open-label trial. Initial safety and efficacy data from Q3M and Q6M dosing in the ALPHA-SOLAR trial are expected mid-2025.
Pending regulatory feedback, the Company plans to initiate the Phase 3 program in Q1 2025 and expects topline results by year-end 2026.
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.
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 every 3 and 6 months. We aim to empower people living with HAE to live life without limitations from their disease.
SOURCE: Astria Therapeutics
Post Views: 104
— Navenibart Demonstrated 6 Months of HAE Attack Prevention with 1 or 2 Doses —
— 90-95% Mean Monthly Attack Rate Reduction Supporting Chronic Dosing 2 or 4 Times Per Year —
— 67% Attack-Free Rate Over 6 Months in Cohorts 2 and 3 —
— Favorable Safety and Well-Tolerated Profile —
— Phase 3 Initiation on Track for Q1 2025 —
BOSTON, MA, USA I December 11, 2024 I Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced positive final results from the target enrollment group of 16 patients in the ALPHA-STAR Phase 1b/2 clinical trial evaluating navenibart (STAR-0215), a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema (HAE) patients. These final results demonstrated reduction in the mean monthly attack rate of 90-95% at 6 months, favorable safety and tolerability profile, and support both every three- (Q3M) and every six-month (Q6M) dosing regimens. The results underscore the potential of navenibart’s profile to be the market-leading therapy for HAE. Astria is advancing navenibart to Phase 3 development with trial initiation expected in Q1 2025.
“The results from the ALPHA-STAR Phase 1b/2 trial affirm our belief in navenibart’s profile and its potential to be a life-changing, market-leading preventative treatment for HAE patients,” said Christopher Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “After one or two doses over six months, patients experienced rapid onset of robust and durable efficacy, favorable safety and tolerability, and PK and PD that are consistent with sustained plasma kallikrein inhibition and Q3M and Q6M administration. These results are highly consistent with the interim results we reported in March. We look forward to presenting these data at an upcoming scientific conference and expect to initiate Phase 3 development in Q1, pending completion of discussions with global regulators.”
“These results from the ALPHA-STAR trial are exciting for the future of the HAE treatment landscape,” said Dr. Aleena Banerji, Clinical Director MGH Allergy and Clinical Immunology Unit. “We understand from people living with HAE that the disease and treatment burden can weigh heavily on their physical and mental health. I am optimistic that a therapy with infrequent dosing, a well-tolerated profile, and a trusted mechanism and modality could alleviate the burden for patients.”
ALPHA-STAR is a dose-ranging proof-of-concept trial in adults with HAE Type 1 or 2 designed to assess safety, tolerability, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and quality of life in patients receiving single and multiple doses of navenibart in three cohorts delivered subcutaneously to prevent attacks in HAE. All cohorts began with an eight-week run-in period to measure baseline HAE attacks and safety, efficacy, PK, and PD are assessed through 6-months (Day 168) after the last dose received. Among the target enrollment (n=16), 88% had Type 1 HAE, the average age was 46 years, and 56% were female.
Cohort 1 evaluated a 450 mg dose (n=4). Results show that, on average, over 6 months:
- 91% reduction in monthly attack rate
- 96% reduction in moderate and severe attacks
- 94% reduction in acute rescue medication use
- 50% of patients were attack-free through 3 months of follow-up, and 25% were attack-free through 6 months of follow-up
Cohort 2 evaluated a 600 mg dose followed by a 300 mg dose three months later (n=6). Results show that, on average, over 6 months:
- 95% reduction in monthly attack rate
- 95% reduction in moderate and severe attacks
- 94% reduction in acute rescue medication use
- 67% of patients were attack-free
Cohort 3 evaluated a 600 mg dose followed by a 600 mg dose one month later (n=6). Results show that, on average, over 6 months:
- 92% reduction in monthly attack rate
- 96% reduction in moderate and severe attacks
- 91% reduction in acute rescue medication use
- 67% of patients were attack-free
PK and PD were consistent with previously reported results and demonstrated rapid and sustained target plasma kallikrein inhibition consistent with effective and safe Q3M and Q6M administration.
Navenibart was generally well-tolerated with no serious treatment-emergent adverse events (TEAEs) and no discontinuations. There were four non-severe and quickly resolved treatment-related TEAEs: one case of dizziness, a transient injection site reaction (rash), an injection site erythema, and an injection site pruritus. There were no injection site reactions of pain.
The results shared above are available in the Company’s corporate presentation in the investor section of www.astriatx.com. The Company expects to present these data at an upcoming scientific conference.
All 16 patients have enrolled into ALPHA-SOLAR, a long-term open-label trial. Initial safety and efficacy data from Q3M and Q6M dosing in the ALPHA-SOLAR trial are expected mid-2025.
Pending regulatory feedback, the Company plans to initiate the Phase 3 program in Q1 2025 and expects topline results by year-end 2026.
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.
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 every 3 and 6 months. We aim to empower people living with HAE to live life without limitations from their disease.
SOURCE: Astria Therapeutics
Post Views: 104
