Ultragenyx Unveils Key Setrusumab Presentations at Major Meeting
Ultragenyx Highlights Significant Setrusumab Findings
Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), based in Novato, California, is set to make waves at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting. The company has announced that it will present seven critical abstracts focused on its late-stage program evaluating setrusumab (UX143) for osteogenesis imperfecta (OI). A key highlight will include a late-breaker oral presentation revealing 14-month data from the Phase 2/3 Orbit Study.
Clinical Impact of Setrusumab on Osteogenesis Imperfecta
Dr. Eric Crombez, the Chief Medical Officer at Ultragenyx, emphasized the importance of the presentations. He remarked that these insights contribute significantly to the understanding of OI's real-world impact and highlight the urgent need for innovative therapies to help patients affected by this condition. Additionally, data from the Phase 2 Orbit study will demonstrate a notable and meaningful rise in bone mineral density along with a reduction in fracture rates over 14 months.
Presentation Details for Setrusumab
Key presentations regarding setrusumab are as follows:
- Title: Integrated Bone Biomarker Analyses to Define Setrusumab Mechanism of Action in Pediatric and Young Adult Subjects with OI and Inform Dose Selection in the Orbit Study.
Session: Welcome Reception and Plenary Poster Session
Presentation Number: Plenary Poster (#Fri-423)
Event Date: September 27, 5:30 p.m. - 7:30 p.m. ET - Title: Burden of Illness of Osteogenesis Imperfecta in Ontario, Canada.
Session: Late Breaking Poster Session I
Presentation Number: #Sat-LB 592
Event Date: September 28, 2:15 p.m. - 3:45 p.m. ET - Title: Manifestations and Comorbid Conditions Among Patients with OI: A US Retrospective Claims Database Analysis.
Session: Poster Session I
Presentation Number: #Sat-447
Event Date: September 28, 2:15 p.m. - 3:45 p.m. ET - Title: Fracture Rates for Patients Living with OI: Real-world Results from US Retrospective Claims.
Session: Poster Session I
Presentation Number: #Sat-446
Event Date: September 28, 2:15 p.m. - 3:45 p.m. ET - Title: Population Pharmacokinetics (PK) and PK/Pharmacodynamics Analyses to Select the Phase 3 Dose of Setrusumab in Pediatric Patients with OI: Results from Phase 2 of the Orbit Study.
Session: Oral Presentations: Pregnancy Associated Bone Loss and Other Rare Bone Diseases
Presentation Number: #1063
Event Date: September 29, 11:45 a.m. - 12:00 p.m. ET - Title: Healthcare Resource Use and Costs for Patients Living with OI: Results from US Retrospective Claims.
Session: Poster Session II
Presentation Number: #Sun-446
Event Date: September 29, 2:15 p.m. - 3:45 p.m. ET - Title: Sustained Reduction in Fracture Rate in Patients with OI Treated with Setrusumab: Fourteen Month Data from Phase 2 of the Phase 2/3 Orbit Study.
Session: Late-Breaking Oral Presentations: Clinical Science
Presentation Number: #1125
Event Date: September 30, 12:00 p.m. - 12:15 p.m. ET
Understanding Osteogenesis Imperfecta
Osteogenesis Imperfecta is a genetic disorder that significantly affects bone metabolism, with approximately 85% to 90% of cases stemming from mutations in the COL1A1 or COL1A2 genes. These mutations affect collagen production, leading to increased bone brittleness. Patients often experience high fracture rates due to inadequate bone formation and heightened resorption, which results in decreased bone density and strength. With no globally approved treatments for OI, this condition affects around 60,000 individuals in accessible regions.
The Role of Setrusumab (UX143)
Setrusumab stands out as a fully human monoclonal antibody targeting sclerostin, a key inhibitor of bone growth. By blocking sclerostin, setrusumab aims to enhance bone formation, increase bone mineral density, and improve overall bone strength in patients with OI. In previous studies involving mouse models, setrusumab showed promising results, enhancing bone formation and normalizing structural integrity against fracture forces.
The partnership between Ultragenyx and Mereo BioPharma has focused on advancing the development of setrusumab globally, capitalizing on a collaboration agreement that seeks to make strides in treating pediatric and young adult patients across various OI subtypes, namely types I, III, and IV.
About Ultragenyx
Ultragenyx is dedicated to the creation of innovative therapies aimed at treating serious rare genetic disorders. Through its extensive portfolio, the company seeks to address conditions that currently have high unmet medical needs and where existing treatments don’t directly target underlying issues. The management team, experienced in the field of rare diseases, is committed to efficient and careful drug development processes. Ultragenyx is focused on delivering safe, effective treatments to patients promptly.
Frequently Asked Questions
What is setrusumab (UX143)?
Setrusumab is a human monoclonal antibody that aims to improve bone density and reduce fractures in patients with osteogenesis imperfecta by inhibiting sclerostin.
Where will the presentations take place?
The presentations will occur at the ASBMR 2024 Annual Meeting, in Toronto, Canada, from September 27-30.
Who is leading the development of setrusumab?
Ultragenyx Pharmaceutical Inc. is collaborating with Mereo BioPharma in the global development of setrusumab.
What is osteogenesis imperfecta?
Osteogenesis imperfecta is a genetic disorder characterized by fragile bones and a high fracture rate, primarily caused by defects in collagen.
What are the objectives of the upcoming studies on setrusumab?
The studies aim to present data on the efficacy and safety of setrusumab in improving bone health for patients with osteogenesis imperfecta.
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