BOSTON, MA, USA I November 10, 2023 IAstria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunological diseases, is presenting new STAR-0215 data in a poster presentation at the American College of Allergy, Asthma, and Immunology (ACAAI) in Anaheim, California that demonstrated STAR-0215’s profile as a potential HAE preventative therapy with robust attack suppression and low treatment burden in healthy adult subjects. These data confirm the potential for STAR-0215 to be dosed once every three months and every six months.
“These new data, including long-term follow-up from the original cohorts and initial data from new, higher dose cohorts, support our vision for STAR-0215 as a first-choice therapy for HAE. These data confirm our approach to administer STAR-0215 once every three and every six months in future trials. We intend to provide patients the option to choose what works best for their lives with a therapy that has a trusted modality and mechanism,” said Chris Morabito, M.D., Chief Medical Officer at Astria. “Our Phase 1b/2 ALPHA-STAR trial in HAE patients is on track and enrolling the third and final cohort. We now expect to deliver initial proof-of-concept data for STAR-0215 as a long-acting preventative therapy for HAE in Q1 2024. Patients from the ALPHA-STAR trial are enrolling in the long-term open label ALPHA-SOLAR trial to continue receiving STAR-0215, with data now accruing in patients who have received multiple doses of STAR-0215.”
In a poster titled, “Support for STAR-0215 Administered Every Three- or Six-Months for Hereditary Angioedema: Phase 1a Results,” Dr. William Lumry, M.D., Clinical Professor of Internal Medicine at the University of Texas Health Science Center at Dallas, is presenting clinical data including randomized, blinded, placebo-controlled, single ascending dose safety and tolerability data. STAR-0215 was well-tolerated, with no serious adverse events or discontinuations due to an adverse event, and low risk of injection pain. STAR-0215 achieved potentially therapeutic levels in less than one day and showed an estimated half-life of up to 127 days. Pharmacokinetic (PK) modeling of potential every three month and every six month clinical dose regimens over one to two years predict PK coverage believed to confer HAE attack prevention. Pharmacodynamic (PD) data showed statistically significant inhibition of plasma kallikrein for 140 to 224 days after single doses greater than 100 mg. These results demonstrate early proof-of-concept in healthy subjects for STAR-0215 as a potential HAE therapy with favorable safety profile, long half-life, and durable PD.
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 immunological diseases. Our lead program, 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 X and Instagram @AstriaTx and on Facebook and LinkedIn.
About STAR-0215:
STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of HAE. Our vision is for STAR-0215 to be the first-choice preventative treatment for people with HAE dosed once every three and six months and to make substantial progress towards normalizing their lives. The Phase 1b/2 ALPHA-STAR trial evaluating STAR-0215 in HAE patients is ongoing, with initial proof-of-concept results expected in the first quarter of 2024.
SOURCE: Astria Therapeutics
Post Views: 145
BOSTON, MA, USA I November 10, 2023 IAstria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunological diseases, is presenting new STAR-0215 data in a poster presentation at the American College of Allergy, Asthma, and Immunology (ACAAI) in Anaheim, California that demonstrated STAR-0215’s profile as a potential HAE preventative therapy with robust attack suppression and low treatment burden in healthy adult subjects. These data confirm the potential for STAR-0215 to be dosed once every three months and every six months.
“These new data, including long-term follow-up from the original cohorts and initial data from new, higher dose cohorts, support our vision for STAR-0215 as a first-choice therapy for HAE. These data confirm our approach to administer STAR-0215 once every three and every six months in future trials. We intend to provide patients the option to choose what works best for their lives with a therapy that has a trusted modality and mechanism,” said Chris Morabito, M.D., Chief Medical Officer at Astria. “Our Phase 1b/2 ALPHA-STAR trial in HAE patients is on track and enrolling the third and final cohort. We now expect to deliver initial proof-of-concept data for STAR-0215 as a long-acting preventative therapy for HAE in Q1 2024. Patients from the ALPHA-STAR trial are enrolling in the long-term open label ALPHA-SOLAR trial to continue receiving STAR-0215, with data now accruing in patients who have received multiple doses of STAR-0215.”
In a poster titled, “Support for STAR-0215 Administered Every Three- or Six-Months for Hereditary Angioedema: Phase 1a Results,” Dr. William Lumry, M.D., Clinical Professor of Internal Medicine at the University of Texas Health Science Center at Dallas, is presenting clinical data including randomized, blinded, placebo-controlled, single ascending dose safety and tolerability data. STAR-0215 was well-tolerated, with no serious adverse events or discontinuations due to an adverse event, and low risk of injection pain. STAR-0215 achieved potentially therapeutic levels in less than one day and showed an estimated half-life of up to 127 days. Pharmacokinetic (PK) modeling of potential every three month and every six month clinical dose regimens over one to two years predict PK coverage believed to confer HAE attack prevention. Pharmacodynamic (PD) data showed statistically significant inhibition of plasma kallikrein for 140 to 224 days after single doses greater than 100 mg. These results demonstrate early proof-of-concept in healthy subjects for STAR-0215 as a potential HAE therapy with favorable safety profile, long half-life, and durable PD.
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 immunological diseases. Our lead program, 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 X and Instagram @AstriaTx and on Facebook and LinkedIn.
About STAR-0215:
STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of HAE. Our vision is for STAR-0215 to be the first-choice preventative treatment for people with HAE dosed once every three and six months and to make substantial progress towards normalizing their lives. The Phase 1b/2 ALPHA-STAR trial evaluating STAR-0215 in HAE patients is ongoing, with initial proof-of-concept results expected in the first quarter of 2024.
SOURCE: Astria Therapeutics
Post Views: 145
