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
For further details see:
Ultragenyx, Mereo gain on Phase 2 data for bone disorder therapy