Angitia Announces FDA Clearance of IND Application for AGA2115, Drug Candidate for Osteogenesis Imperfecta
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).
Angitia Announcement – New Board Director Appointed
Guangzhou, China and Woodland Hills, USA: Angitia Biopharmaceuticals is delighted to announce the appointment of Mr. David A Piacquad as an Independent Board Director.
Angitia Biopharmaceuticals Announces Positive Topline Results from AGA111 Phase 1/2 Trial for Spinal Fusion
Guangzhou, Guangdong, China, and Woodland Hills, California, USA: Angitia Biopharmaceuticals (Angitia) today announced the successful conclusion and positive top-line results of a phase 1/2 study entitled ‘A randomized, double-blind, placebo-controlled study to evaluate the safety and preliminary efficacy of a single intervertebral administration of AGA111 in patients with degenerative disc disease undergoing interbody fusion’. The results from this trial demonstrated an excellent safety profile and preliminary efficacy in increasing fusion rate and improving clinical outcome.