AGA111 Shows Promising Results in Spinal Fusion Clinical Trial, Advances to Phase 3
• Angitia Biopharmaceuticals' Phase 1/2 study demonstrated that AGA111, a recombinant human bone morphogenetic protein 6, achieved faster radiographic fusion and higher fusion success rates compared to placebo in spinal fusion procedures.
• The randomized, double-blind trial enrolled 63 patients with degenerative disc disease requiring Transforaminal Lumbar Interbody Fusion surgery, showing significant improvements in functional outcomes measured by Oswestry Disability Index and pain visual analog scale.
• Based on these encouraging results, Angitia has initiated a registrational Phase 3 study of AGA111, which could potentially transform treatment outcomes for the over 446,000 patients undergoing spinal fusion procedures annually in the US and China.
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 Doses First Patient in Phase 2 Trial of AGA2118 for Osteoporosis
• Angitia Biopharmaceuticals has dosed the first patient in its Phase 2 ARTEMIS trial evaluating AGA2118 for postmenopausal osteoporosis.
• 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.
• AGA2118 is a bispecific antibody targeting sclerostin and DKK1, aiming to enhance bone mineral density gains by preventing compensatory increases of either agent.
• The global osteoporosis epidemic affects over 200 million people, highlighting the unmet need for new therapies with improved efficacy and safety profiles.
© Copyright 2025. All Rights Reserved by MedPath