Woodland Hills, California, USA and Guangzhou, Guangdong, China  –  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 U.S. Food and Drug Administration (FDA) has cleared Angitia Biopharmaceuticals’ Investigational New Drug (IND) for AGA2115, an investigational therapy for the treatment of osteogenesis imperfecta (OI). The FDA previously granted AGA2115 an Orphan Drug Designation (ODD) and a Rare Pediatric Disease Designation (RPDD).

AGA2115 is being developed as a first-in-class investigational drug candidate for the treatment of OI, a life-threatening skeletal condition. Data from preclinical disease models demonstrated AGA2115’s robust activity in increasing bone mass and bone strength, improving bone structure and dramatically reducing skeletal fractures.

“Osteogenesis imperfecta is a devastating disease with no FDA-approved therapies. Based on the encouraging preclinical data we have observed, we believe AGA2115 has potential to change the course of the disease and meaningfully improve patient outcomes,” said David Ke, M.D., Founder and CEO of Angitia. “We are excited to start the first-in-human (FIH) study for AGA2115 to evaluate the potential for this investigational therapy. Additionally, this is an important milestone for Angitia, as our first program to receive FDA clearance to enter the clinic.”

AGA2115 PHASE Ⅰ STUDY

The Phase Ⅰ, FIH, 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.

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

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. Founded in 2018, Angitia has operations in Guangzhou, China and in Woodland Hills, California, USA.

Learn more at www.angitiabio.com.