Mereo Biopharma's Setrusumab Shows Promising Outlook Amid Phase 3 Trial Advancements

Mereo Biopharma's Phase 3 trial for setrusumab is advancing, with a promising outlook despite the interim analysis not meeting predefined criteria. The potential market for the treatment is substantial, addressing an unmet need in osteogenesis imperfecta with a large patient population in the US and Europe. Analyst Julian Harrison maintains a Buy rating and $6.00 price target, expecting the net present value of Mereo's rights to setrusumab to exceed $1 billion.

Mereo Biopharma Group plc (NASDAQ: MREO) has announced that the randomized, placebo-controlled Phase 3 portion of the Orbit study evaluating UX143 (setrusumab) in pediatric and young adult patients with osteogenesis imperfecta (OI) is progressing toward a final analysis, expected around the end of the year [1]. The Data Monitoring Committee (DMC) met and informed the company that UX143 demonstrates an acceptable safety profile and that the study should continue to the final analysis.

The interim analysis did not meet the predefined criteria, but the study is continuing as planned. The threshold for the Phase 3 Orbit final analysis is p0.04. Consistent with the statistical analysis plan, data from the Cosmic study were not analyzed at this interim timepoint. The Cosmic study is an open-label, randomized, active-controlled study in patients aged 2 to 7 years, with a threshold for the Phase 3 Cosmic final analysis of p0.05.

The potential market for the treatment is substantial, addressing an unmet need in osteogenesis imperfecta with a large patient population in the US and Europe. Analyst Julian Harrison maintains a Buy rating and $6.00 price target, expecting the net present value of Mereo's rights to setrusumab to exceed $1 billion [2].

References:
[1] https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-and-mereo-biopharma-announce-ux143-phase-3-orbit
[2] https://www.meroeo.com