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Angitia Biopharmaceuticals Doses First Patient in Phase 2 Trial of AGA2118 for Osteoporosis

• Angitia Biopharmaceuticals has initiated a Phase 2 clinical trial (ARTEMIS) of AGA2118 for treating postmenopausal osteoporosis. • The ARTEMIS trial is a randomized, double-blind, placebo-controlled study involving approximately 350 postmenopausal women. • AGA2118, a bispecific antibody, targets sclerostin and DKK1 to enhance bone mineral density (BMD) in osteoporosis patients. • The primary endpoint of the study is the percent change from baseline in BMD at the lumbar spine at 12 months.

Angitia Biopharmaceuticals has announced the dosing of the first patient in its Phase 2 ARTEMIS trial, evaluating AGA2118 for the treatment of osteoporosis. This randomized, double-blind, placebo-controlled study, conducted across the US and EU, aims to assess the efficacy of AGA2118 in increasing bone mineral density (BMD) in postmenopausal women. The trial plans to enroll approximately 350 participants.

AGA2118: A Novel Bispecific Antibody

AGA2118 is a bispecific antibody targeting sclerostin and DKK1, two key negative regulators of the WNT signaling pathway involved in bone metabolism. By inhibiting both proteins, AGA2118 aims to prevent compensatory increases of either agent, potentially leading to improved BMD gains in osteoporotic patients. Angitia Biopharmaceuticals wholly owns the rights to this antibody.

Trial Design and Endpoints

The ARTEMIS trial's primary endpoint is the percent change from baseline in BMD at the lumbar spine at 12 months. Secondary endpoints include percent changes in BMD at other anatomical locations and time points, as well as changes in biochemical markers of bone turnover. The study also includes an open-label extension through Month 24.

Osteoporosis: An Unmet Medical Need

Osteoporosis is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, leading to increased bone fragility and fracture risk. It is a global epidemic, affecting more than 200 million people worldwide, particularly older women. While several approved therapies exist, limitations in efficacy and safety persist, leaving a significant unmet medical need for new osteoporosis treatments.

Prior Clinical Data

First-in-human data on AGA2118, presented at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting, demonstrated rapid and robust gains in bone mineral density, according to Dr. Willard H. Dere, M.D., Chief Medical Officer of Angitia. The Phase 2 study is expected to build on these findings, further evaluating the potential of AGA2118 as a differentiated therapy for osteoporosis.

Angitia's Broader Pipeline

In addition to AGA2118, Angitia Biopharmaceuticals is studying three other biologic product candidates in clinical trials for the treatment of osteogenesis imperfecta (OI) and spinal fusion.
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Angitia Biopharmaceuticals Doses First Patient in Phase 2 Trial of AGA2118 for Osteoporosis

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The ARTEMIS trial is a randomized, double-blind, placebo-controlled study assessing the change in bone mineral density at the lumbar spine over 12 months.

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Reference News

[1]
Angitia doses first subject in Phase II trial of AGA2118 for treating osteoporosis
clinicaltrialsarena.com · Nov 5, 2024

Angitia Biopharmaceuticals has initiated a Phase II clinical trial of AGA2118, a bispecific antibody for osteoporosis, a...

[2]
Angitia Biopharmaceuticals Announces Dosing of First Patient in Phase 2 Clinical Trial of ...
biospace.com · Nov 5, 2024

Angitia Biopharmaceuticals announced the first patient dosing in its Phase 2 ARTEMIS study of AGA2118, a bispecific anti...

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