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Angitia Biopharmaceuticals to Present Data on AGA2115 for Osteogenesis Imperfecta at ASBMR 2025

- Angitia abstracts selected for two oral presentations and three posters

- Angitia collaborator also selected for poster presentation

WESTLAKE VILLAGE, Calif., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Angitia Biopharmaceuticals, a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases, today announced that data from its ongoing program evaluating AGA2115 for the treatment of osteogenesis imperfecta (OI) will be presented at the American Society for Bone and Mineral Research 2025 Annual Meeting (ASBMR) September 5-8, 2025, in Seattle, WA.   Conference organizers selected preclinical and clinical abstracts for AGA2115 (or surrogate rodent antibody) submitted by the Company as highlights of the Annual Meeting, of which two were selected for oral presentations.

Details of the oral presentations are as follows:

Title: AGA2115, a Bispecific Antibody Neutralizing DKK1 and Sclerostin, Increased Bone Formation, Decreased Bone Resorption, and Led to Significant BMD Gains in a First-in-Human, Single- and Multiple-dose, Placebo-Controlled Randomized Study
Presenter: Eric Orwoll, M.D.
Session Title: Treatments of Rare Bone Diseases
Session Date and Time: Saturday, September 6, 2025, 11:15 – 12:30 pm
Presentation Time: 11:15 am
Abstract Number: 1036

Title: AGA2115, a Bispecific Antibody Neutralizing Both Dickkopf-1 (DKK1) and Sclerostin Increased Bone Formation and Decreased Bone Resorption Resulting in Significant Gains in Bone Mass and Strength in Nonhuman Primates (NHPs)
Presenter: Ann Zovein, M.D.
Session Title: Uncommon Skeleton: Bench Discoveries in Rare Bone Disorders
Session Date and Time: Sunday, September 7, 2025, 3:45 – 5:00 pm
Presentation Time: 3:45 pm
Abstract Number: 1096

Three abstracts will be presented as posters, along with one additional poster presentation from a collaborator, the Willie Laboratory at the Shriners Hospital for Children, Research Center. The Willie Laboratory will also host a poster preview talk at the conference on September 4, the day prior to the meeting.

Details of the poster presentations are as follows:

Title: A Bispecific Antibody Targeting Dickkopf-1 and Sclerostin Enhances Bone Mass, Microstructure, and Strength in the Brtl/+ Mouse Model of Osteogenesis Imperfecta
Presenter: Michal Kulasek, Ph.D.
Session Titles: Poster Preview Talk: From the Genome to the Lived Experience; Welcome Reception and Plenary Poster Session; Poster Session II – Basic and Translational
Session Dates and Times: Thursday, September 4, 2025, 2:45 pm – 4:30 pm; Friday, September 5, 2025, 5:00 – 6:30 pm; Sunday, September 7, 2025, 2:00 – 3:30 pm
Abstract Number: 287

Title: AGA2115, a Bispecific Antibody Neutralizing Both Dickkopf-1 (DKK1) and Sclerostin, Increased Bone Formation and Bone Formation Biomarkers Remained Elevated Throughout the 6-month Nonhuman Primate (NHP) Study
Presenter: Baozhi Yuan, Ph.D.; Ann Zovein, M.D.
Session Titles: Welcome Reception and Plenary Poster Session; Poster Session I – Basic and Translational
Session Dates and Times: Friday, September 5, 2025, 5:00 – 6:30 pm; Saturday, September 6, 2025, 2:00 – 3:30 pm
Abstract Number: 294

Title: A Bispecific Antibody Neutralizing Both Dickkopf-1 (DKK1) and Sclerostin Reduces Spontaneous Fractures by Increasing Bone Mass, and Improving Bone Structure and Material Properties in the oim/oim Osteogenesis Imperfecta (OI) Mouse Model
Presenter: Ann Zovein, M.D.
Session Titles: Welcome Reception and Plenary Poster Session; Poster Session II – Basic and Translational
Session Dates and Times: Friday, September 5, 2025, 5:00 – 6:30 pm; Sunday, September 7, 2025, 2:00 – 3:30 pm
Abstract Number: 295

Title: Preclinical and Clinical Pharmacokinetics of AGA2115, A Bispecific Antibody Neutralizing Both Dickkopf-1 (DKK1) and Sclerostin, for the Treatment of Osteogenesis Imperfecta
Presenter: Nancy Zheng, Ph.D.
Session Titles: Welcome Reception and Plenary Poster Session; Poster Session I – Clinical
Session Dates and Times: Friday, September 5, 2025, 5:00 – 6:30 pm; Saturday, September 6, 2025, 2:00 – 3:30 pm
Abstract Number: 401

About Osteogenesis Imperfecta

Osteogenesis imperfecta (OI) is an inherited connective tissue disorder with pathophysiology driven by abnormal collagen metabolism resulting in skeletal deformity, bone fragility, reduced bone mass, and variable extra-skeletal symptoms. OI occurs in approximately 1 in 15,000 births, with between 20,000 to 50,000 affected individuals in the United States. As a rare pediatric disease, OI ranges in severity from mild to severe and life-threatening. Disease manifestations occur in the neonatal and pediatric age groups, presenting with frequent and recurrent fractures, often elicited by little or no trauma. Severe OI cases manifest with multiple debilitating fractures resulting in loss of independent movement, deformity, and stunted growth, or, in severe cases, perinatal mortality. Patients also suffer from muscle weakness, joint laxity, dental issues, hearing loss, and skeletal malformations.

There are no approved therapies for the treatment of OI.

About AGA2115

AGA2115 is a first-in-class, bispecific antibody being developed for the treatment of osteogenesis imperfecta. The U.S. Food and Drug Administration (FDA) has granted AGA2115 Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) and the EMA has also granted AGA2115 an ODD. A Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending-dose study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of AGA2115 in adult healthy volunteers. A Phase 2 study is planned to evaluate the efficacy of AGA2115 in adult OI patients, with additional studies in pediatric patients to follow.

About Angitia Biopharmaceuticals

Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying three biologic product candidates in the clinic for the treatment of osteoporosis, osteogenesis imperfecta (OI), and spinal fusion. Leveraging the team's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs.

Learn more at www.angitiabio.com.

Investor & Media Contact:

William Windham
Solebury Strategic Communications
wwindham@soleburystrat.com
646-378-2946

Forward-Looking Statements

This press release is prepared by Angitia Biopharmaceuticals (the “Company”, “We”) for informational purposes only. Forward-looking statements include all statements that are not historical facts, and in some cases, can be identified by terms such as “anticipate”, “expect”, “intend”, “plan”, “believe”, “continue”, “could”, “potential”, “may”, “will”, “goal” or similar expressions and the negatives of those terms. However, not all forward-looking statements contain these identifying words.

These forward-looking statements involve substantial known and unknown risks and uncertainties, including the risk that results in earlier clinical studies may not be indicative of future results and that any product candidates may not ultimately obtain required approvals or meaningfully improve patient outcomes, and other factors that are beyond the Company’s control and are difficult to predict and may cause our actual results, timing of results, or achievements to be materially different from the information expressed or implied by these forward-looking statements. We anticipate that subsequent events and developments may cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law.

Except as expressly required by law, the Company and/or its officers, directors, employees, and agents shall not assume responsibility for the accuracy and completeness of the forward-looking statements in the information provided.


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