WOODLAND HILLS, Calif., Nov. 04, 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 the dosing of the first patient in ARTEMIS, its Phase 2 study of AGA2118, a bispecific antibody targeting sclerostin and DKK1, for the treatment of osteoporosis.
"The dosing of the first patient in our Phase 2 study marks an important milestone in the development of AGA2118 for patients with postmenopausal osteoporosis," said Dr. Willard H. Dere, M.D., Chief Medical Officer of Angitia. "The data from this study will build on the first-in-human data on AGA2118 presented recently at ASBMR, which demonstrated rapid and robust gains in bone mineral density. We look forward to advancing this novel, differentiated therapy for the treatment of osteoporosis."
The Phase 2 study is a randomized, double-blind, placebo-controlled, dose-ranging study with a primary analysis at Month 12 and an open-label extension through Month 24. The study will enroll approximately 350 postmenopausal women with osteoporosis, and the primary endpoint of the study is the percent change from baseline in bone mineral density (BMD) at the lumbar spine at 12 months. Secondary endpoints include percent change in BMD at additional anatomic locations and time points and the changes in biochemical markers of bone turnover.
Angitia presented first-in-human data on AGA2118 at the American Society for Bone and Mineral Research 2024 Annual Meeting, September 27-30, 2024, in Toronto, Canada.
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.
Angitia is developing AGA2118 in OLYMPUS (Osteoporosis Longitudinal multi-Year prograM to evaluate Postmenopausal women at risk for fractUreS), and the drug candidate is currently under investigation in the ARTEMIS Phase 2 study (A Phase 2 Randomized Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS).
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 Windham
Solebury Strategic Communications
646-378-2946
Forward-Looking Statements
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 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.