– AGA2115 also received Orphan Drug Designation from European Medicines Agency
WESTLAKE VILLAGE, CA, USA I June 12, 2025 I Angitia Biopharmaceuticals, a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases, today announced topline results from its first in human (FIH) study of AGA2115, its bispecific antibody under development for the treatment of Osteogenesis Imperfecta (OI). The Phase 1, randomized, double-blind, and placebo-controlled study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of AGA2115 in adult healthy male and female volunteers.
AGA2115 is a first-in-class bispecific antibody developed by Angitia. This FIH study of AGA2115 demonstrated a favorable safety profile with a rapid increase in bone formation and simultaneous decrease in bone resorption, leading to robust increases in bone mineral density (BMD) in both single and multiple ascending-dose cohorts.
Dr. Willard H. Dere, M.D., Chief Medical Officer of Angitia, commented, “The top-line results from our Phase 1 study highlight the promise of AGA2115 as a novel therapeutic approach for patients living with osteogenesis imperfecta, a progressive and debilitating disease. These early findings suggest that AGA2115 has the potential to alter the course of OI and address key aspects of disease burden. We are encouraged by the emerging data and are committed to advancing AGA2115 through clinical development in close collaboration with global regulatory agencies, with the goal of bringing meaningful innovation to OI patients and their families.”
Angitia also received confirmation that the European Medicines Agency (EMA) granted Orphan Drug Designation (ODD) to AGA2115. The EMA grants ODD to medicines intended for the treatment, prevention, or diagnosis of rare, life-threatening or chronically debilitating diseases without a satisfactory treatment available. ODD grants certain incentives, including increased regulatory engagement and market exclusivity.
AGA2115 is a first-in-class bispecific antibody developed by Angitia. The Company intends to initiate a Phase 2 study of AGA2115 for the treatment of OI in adult patients, with additional studies in pediatric patients to follow.
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 with 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.
SOURCE: Angitia Biopharmaceuticals
Post Views: 964
– AGA2115 also received Orphan Drug Designation from European Medicines Agency
WESTLAKE VILLAGE, CA, USA I June 12, 2025 I Angitia Biopharmaceuticals, a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases, today announced topline results from its first in human (FIH) study of AGA2115, its bispecific antibody under development for the treatment of Osteogenesis Imperfecta (OI). The Phase 1, randomized, double-blind, and placebo-controlled study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of AGA2115 in adult healthy male and female volunteers.
AGA2115 is a first-in-class bispecific antibody developed by Angitia. This FIH study of AGA2115 demonstrated a favorable safety profile with a rapid increase in bone formation and simultaneous decrease in bone resorption, leading to robust increases in bone mineral density (BMD) in both single and multiple ascending-dose cohorts.
Dr. Willard H. Dere, M.D., Chief Medical Officer of Angitia, commented, “The top-line results from our Phase 1 study highlight the promise of AGA2115 as a novel therapeutic approach for patients living with osteogenesis imperfecta, a progressive and debilitating disease. These early findings suggest that AGA2115 has the potential to alter the course of OI and address key aspects of disease burden. We are encouraged by the emerging data and are committed to advancing AGA2115 through clinical development in close collaboration with global regulatory agencies, with the goal of bringing meaningful innovation to OI patients and their families.”
Angitia also received confirmation that the European Medicines Agency (EMA) granted Orphan Drug Designation (ODD) to AGA2115. The EMA grants ODD to medicines intended for the treatment, prevention, or diagnosis of rare, life-threatening or chronically debilitating diseases without a satisfactory treatment available. ODD grants certain incentives, including increased regulatory engagement and market exclusivity.
AGA2115 is a first-in-class bispecific antibody developed by Angitia. The Company intends to initiate a Phase 2 study of AGA2115 for the treatment of OI in adult patients, with additional studies in pediatric patients to follow.
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 with 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.
SOURCE: Angitia Biopharmaceuticals
Post Views: 964
