MREO - Ultragenyx Mereo gain on Phase 2 data for bone disorder therapy

2023-06-06 08:23:18 ET

Shares of Ultragenyx Pharmaceutical ( NASDAQ: RARE ) and Mereo BioPharma ( MREO ) gained in the pre-market Tuesday after the biotechs announced mid-stage data for setrusumab, a monoclonal antibody targeted at the bone disorder osteogenesis imperfecta (OI).

Citing data from the dose-selection Phase 2 portion of the Phase 2/3 Orbit study, the companies said that setrusumab led to a statistically significant increase in serum P1NP, an indicator of bone formation, and a sharp rise in bone mineral density (BMD) in three months.

There are no approved therapies for OI, which represents a group of hereditary disorders affecting bone metabolism.

At the 20 mg/kg dose selected for Phase 3 development, the mean serum P1NP increase stood at 57% from baseline compared to no significant mean serum P1NP changes seen in patients on placebo over one month.

Meanwhile, the lumbar spine BMD has risen 9.4% and 9.8% from baseline after receiving setrusumab for three months at 20 mg/kg (n=10) and 40 mg/kg (n=7) doses, respectively. Those on placebo (n=2) indicated no significant change in BMD from baseline at that timepoint.

There were no treatment-related serious adverse events at the time of the data cut. Ultragenyx ( RARE ) and Mereo ( MREO ) are collaborating in the global development of setrusumab. The companies have started screening for the Phase 3 portion of the trial.

More on setrusumab

• Mereo BioPharma, Ultragenyx report secondary endpoint data in trial for bone disorder
• Mereo BioPharma +8% on rare pediatric disease tag for setrusumab

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