Mereo BioPharma Group Plc is a biopharmaceutical company, which engages in the development and commercialization of therapeutics that aim to improve outcomes for oncology and rare diseases. Its portfolio include Etigilimab (MPH-313), Alvelestat (MPH-966), Setrusumab (BPS-804), Navicixizumab (OMP-305B83), Acumapimod (BCT-197), and Leflutrozole (BGS-649). The company was founded by Denise Vera Scots-Knight, Charles Edward Sermon, Alastair Graham MacKinnon, and John P. Richard in March 10, 2015 and is headquartered in London, the United Kingdom.
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- Sentynl Therapeutics and Mereo BioPharma have entered into an option and license agreement granting Sentynl U.S. commercial rights to alvelestat, a potential first-in-class oral neutrophil elastase inhibitor for AATD-LD. - Mereo will receive an upfront option fee and, upon option exercise, up to $40 million in upfront and R&D payments until NDA filing, plus double-digit tiered royalties on U.S. net sales. - Alvelestat is being readied for a global Phase 3 study, backed by positive efficacy data from two Phase 2 studies, with initiation potentially in early 2027. - AATD-LD is a rare genetic respiratory disease affecting an estimated 50,000–80,000 individuals in the United States, with no approved oral therapy currently available.
- Ultragenyx and Mereo BioPharma announced results from two Phase 3 studies evaluating setrusumab, a sclerostin-inhibiting monoclonal antibody, for treating osteogenesis imperfecta in pediatric patients. - The ORBIT study enrolled 159 patients aged 5-25 years across 45 sites in 11 countries, comparing setrusumab to placebo with annualized clinical fracture rate as the primary endpoint. - The COSMIC study enrolled 69 patients aged 2-7 years across 21 sites in 7 countries, comparing setrusumab to intravenous bisphosphonates therapy. - Setrusumab targets an unmet medical need in osteogenesis imperfecta, a rare genetic bone disorder affecting approximately 60,000 people globally with no currently approved treatments.
- āshibio has secured an exclusive global licensing agreement with Mereo BioPharma for vantictumab, a first-in-class monoclonal antibody targeting autosomal dominant osteopetrosis type 2 (ADO2). - ADO2 affects 1 in 20,000 births and causes dense, brittle bones leading to multiple fractures, poor healing, and nerve compression, with no currently approved therapies available. - Vantictumab inhibits Wnt signaling pathways and has demonstrated favorable safety profiles in previous oncology trials, with biomarker data supporting its activity on osteoclast function. - The licensing agreement grants āshibio worldwide development and commercialization rights excluding Europe, where Mereo retains commercial rights.
- Up to 3,500 FDA staffers received termination notices following a Supreme Court ruling that found the government's HHS overhaul to be lawful. - FDA Commissioner Marty Makary proposed lowering prescription drug user fees and offering speedier reviews to companies willing to reduce drug costs. - The agency released over 200 complete response letters for transparency, revealing rejection rationales for previously approved therapies including Eli Lilly's Alzheimer's drug Kisunla. - Two rare disease therapy rejections were issued to Ultragenyx for Sanfilippo syndrome type A and Capricor Therapeutics for DMD-associated cardiomyopathy.
- Ultragenyx and Mereo BioPharma announced that the Phase 3 Orbit study evaluating setrusumab (UX143) in pediatric and young adult patients with osteogenesis imperfecta is progressing toward final analysis around the end of 2025. - The Data Monitoring Committee confirmed setrusumab demonstrates an acceptable safety profile and recommended continuing the study to final analysis after at least 18 months of therapy. - The companies are developing setrusumab, a fully human monoclonal antibody targeting sclerostin, for a rare genetic bone disorder affecting approximately 60,000 people globally with no approved treatments. - Final analyses for both the Orbit study (p<0.04 threshold) and Cosmic study (p<0.05 threshold) are expected around the end of the year.
- Phase II results for setrusumab demonstrated significant improvements in fracture rates and bone strength, supporting continued development despite initial Phase III interim analysis outcomes. - Mereo's alvelestat received EMA Orphan Designation, adding to its existing FDA Fast Track and Orphan Drug Designations, strengthening its regulatory position. - The company's robust financial position extends through 2027, providing stable support for ongoing clinical development programs and strategic partnerships.
• Ultragenyx's setrusumab (UX143) has been granted Breakthrough Therapy Designation by the FDA to reduce fracture risk in osteogenesis imperfecta (OI) patients. • The FDA's decision was based on positive data from the Phase 2 Orbit study and Phase 2b ASTEROID study, demonstrating a significant reduction in fracture rates. • Setrusumab, a fully human monoclonal antibody, inhibits sclerostin to enhance bone formation, density, and strength in OI patients. • The Breakthrough Therapy Designation aims to expedite the development and review of setrusumab, offering hope for an approved treatment option for OI.
