AGA-2118

Clinical data demonstrated treatment with AGA2118 resulted in dose-dependent increases in bone mineral densityWOODLAND HILLS, Calif., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Angitia Biopharmaceuticals, a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases, today announced data from its ongoing program evaluating AGA2118 for the treatment of osteoporosis, as presented at the American Society for Bone and Mineral Research 2024 Annual Meeting (ASBMR) on September 27-30, 2024, in Toronto, ON, Canada. Treatment with AGA2118, a bispecific antibody targeting both sclerostin and DKK1, led to rapid and durable increases in bone formation, decreases in bone resorption, and improvements in bone mineral density (BMD) and bone strength in humans and in animal models, as highlighted in multiple abstracts presented at the conference. “AGA2118 is the first clinical stage bispecific antibody to target two key regulators of bone metabolism, and our first-in-human data demonstrate clinical proof-of-concept for AGA2118,” said David Ke, M.D., Chairman and Chief Executive Officer of Angitia. “AGA2118 is well-tolerated and possesses a pharmacokinetic profile that has translated well to the clinic. In men and otherwise healthy postmenopausal women, we observed rapid and robust bone mineral density gains. We look forward to engaging regulators and continuing development in a diseased population.” In the first-in-human (FIH) trial, 88 men and otherwise healthy postmenopausal women, received AGA2118 or placebo (randomized 6:2) either subcutaneously or intravenously. Subjects were either dosed with a single dose of AGA2118 up to 15 mg/kg or multiple doses of AGA2118 up to 12mg/kg every 4 weeks for a total of three doses and were followed for 85 days in the single ascending dose (SAD) cohort or 169 days in the multiple ascending dose (MAD) cohort. AGA2118 was safe and well-tolerated at all dose levels tested, with adverse events balanced between treatment and placebo. No treatment-related serious adverse events (SAEs) were reported. In addition to safety, the Company observed clinical activity, including dose-dependent increases in bone formation markers P1NP, BSAP, and osteocalcin, as well as dose-dependent decreases in the bone resorption marker CTX-1. In both SAD and MAD cohorts, BMD increased from baseline in the lumbar spine, total hip, and femoral neck in a dose- and exposure-dependent manner. “The rapidity and robustness of the BMD and biomarker responses with AGA2118 in this first-in-human trial demonstrate the potential of AGA2118 to become an important new treatment option for patients with skeletal disease,” said Matthew Drake, M.D., Ph.D., Associate Professor of Medicine at the Mayo Clinic, Divisions of Endocrinology and Hematology. “In addition, the pharmacokinetics and safety of AGA2118 support further development.” The abstract and oral presentation outlining the FIH trial is entitled, “AGA2118, a Bispecific Antibody Neutralizing both Sclerostin and DKK1, Increased Bone Formation, Decreased Bone Resorption, and Led to Rapid BMD Gains in a First in Human, Single- and Multiple-Dose, Placebo-Controlled Randomized Study." Angitia made three additional presentations at ASBMR, including a second oral presentation and two posters. Those presentations summarize data from AGA2118 in a non-human primate (NHP) model of osteoporosis, AGA2118 pharmacokinetics (PK) in NHPs and humans, and long-term follow-up in NHPs treated with AGA2118. Results translated well from preclinical models to humans, and the PK profile of AGA2118 is supportive of future development. About Osteoporosis Osteoporosis is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Osteoporosis has become a global epidemic, especially for older women, due to an aging population and longer life expectancies. Estimates indicate that more than 200 million patients worldwide suffer from osteoporosis. Although there are a number of approved therapies for osteoporosis, limitations remain regarding the efficacy and/or safety of each of these options. Research also indicates that most severely osteoporotic individuals do not receive a bone-active agent. As a result, a large unmet medical need remains for the development of new osteoporosis therapies. About AGA2118 AGA2118 is a bispecific antibody that targets sclerostin and DKK1 and is in clinical development for the treatment of osteoporosis. Sclerostin and DKK1 are two critical, negative regulators of WNT signaling in osteoblasts and of bone metabolism. By targeting both proteins, AGA2118 is thought to prevent compensatory increase of either agent, aiming to improve the magnitude of bone mineral density gains in osteoporotic patients. Angitia wholly owns the bispecific antibody. 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 3 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 WindhamSolebury Strategic Communicationswwindham@soleburystrat.com646-378-2946 Forward-Looking Statements This press release is prepared by Angitia (the “Company”, “We”) for informational purposes only. 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