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Angitia Biopharmaceuticals Announces the First Subject Dosed in the Phase Ⅰ Trial of AGA2115, a Novel Biologic for the Treatment of Osteogenesis Imperfecta

2023-10-17

Woodland Hills, California, USA – 17 Oct 2023 Angitia Biopharmaceuticals, a global clinical-stage biotechnology company focused on the discovery and development of breakthrough therapies that address the unmet medical needs of patients with serious musculoskeletal disease, announced today that the first subject has been successfully dosed in the Phase Ⅰ clinical trial of AGA2115. The First-in-Human (FIH) trial is evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of AGA2115, an investigational therapy for the treatment of osteogenesis imperfecta (OI).

The FDA has previously granted AGA2115 an Orphan Drug Designation (ODD) and a Rare Pediatric Disease Designation (RPDD).

“Osteogenesis Imperfecta is a devastating genetic disorder that affects the skeleton resulting in bone brittleness and frequent debilitating fractures, and currently has no FDA-approved therapies” said David Ke, M.D., Founder and CEO of Angitia. “Dosing the first patient in our first-in-human study of AGA2115 represents an important milestone for the company, our scientists, and the patients we hope to serve.”

ABOUT AGA2115 AND THE PHASE I STUDY

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). The Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending-dose study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AGA2115 in adult healthy volunteers and in adults and adolescents with OI.

Visit clinicaltrials.gov (NCT06086613) for more information.

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 US. As a rare pediatric disease, OI ranges in severity ranging 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 ambulation, deformity, and stunted growth, with the most severe cases resulting in perinatal mortality. Associated features may include muscle weakness, joint laxity, issues with dentition, hearing loss, and skeletal malformations.

ABOUT ANGITIA BIOPHARMACEUTICALS

Founded in 2018, Angitia is a clinical-stage biotechnology company focused on the discovery and development of breakthrough therapeutics that address the key unmet medical needs in serious musculoskeletal disease. With the team’s experience and scientific expertise in novel drug development, Angitia is dedicated to bringing innovative therapies to help patients in need.

Learn more at www.angitiabio.com.

Forward-Looking Statement

This press release is prepared by Angitia (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 are based on the current projects, expectations, assumptions, and understandings of the Company with respect to future events as of the date these statements are made. These statements are not a guarantee or warranty of future developments or otherwise.

These statements involve substantial known and unknown risks, uncertainties, 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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