Mereo Biopharma Group (MREO) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Key program updates and clinical progress

• Setrusumab for Osteogenesis imperfecta (OI) showed a 67% reduction in fractures in phase II, with strong statistical significance and consistent results at 6 and 14 months.

• Bone mineral density (BMD) improvements were substantial, especially in younger patients, with a mean change of 22% overall and 30% in ages 5–12.

• Z-score improvements indicate normalization of bone health toward the general population.

• Phase III studies are well powered, with a high proportion of severe (Type III) patients, and are expected to yield more accurate fracture rates.

• Phase III data readout is anticipated in 2025, with interim analyses in late 2024 and early 2025.

Patient impact and broader benefits

• Patient-reported outcomes (PROs) on pain and mobility are being tracked, with updates expected at ASBMR.

• Survey data highlight pain, mobility, and hearing loss as key concerns for OI patients.

• Notable improvements in mobility observed, including patients moving from wheelchairs to walking and playing sports.

• Hearing loss, potentially due to microfractures, is being monitored in phase III.

Commercialization, partnerships, and market access

• Partnership with Ultragenyx includes $50M upfront, $9M milestone received, and up to $245M in future milestones, with EU rights retained and mutual royalties.

• Collaborative committees oversee development, regulatory, commercial, and manufacturing activities.

• Early groundwork for European reimbursement includes engagement with EUnetHTA, MoCA, G-BA (Germany), and NICE (UK), with constructive feedback received.

• Patient identification efforts found 5,000 pediatric and 5,000 adult eligible patients in key EU countries, expanding to Nordics and Benelux.