Mereo BioPharma’s Phase II ASTEROID study with setrusumab in osteogenesis imperfecta (OI) failed to achieve its primary endpoint, but the overall data was compelling. The gold standard for measuring bone mineral density (BMD) and indirectly bone strength, DXA, was a secondary endpoint and this achieved clear positive outcomes. There were significant increases in BMD in various bones, which were materially greater than that seen with teriparatide or bisphosphonates. Consistent with the total BMD data, there was a trend of reduction in fractures (trial not powered for significance). Mereo is now advancing with its plans for the pivotal trial programme, subject to financing. It should also be remembered that there is currently no approved medication for OI. Our valuation is 506p/share or $25.59/ADS.
25 Nov 2019
Setrusumab ready to advance into pivotal studies
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Setrusumab ready to advance into pivotal studies
- Published:
25 Nov 2019 -
Author:
Mick Cooper PhD -
Pages:
10
Mereo BioPharma’s Phase II ASTEROID study with setrusumab in osteogenesis imperfecta (OI) failed to achieve its primary endpoint, but the overall data was compelling. The gold standard for measuring bone mineral density (BMD) and indirectly bone strength, DXA, was a secondary endpoint and this achieved clear positive outcomes. There were significant increases in BMD in various bones, which were materially greater than that seen with teriparatide or bisphosphonates. Consistent with the total BMD data, there was a trend of reduction in fractures (trial not powered for significance). Mereo is now advancing with its plans for the pivotal trial programme, subject to financing. It should also be remembered that there is currently no approved medication for OI. Our valuation is 506p/share or $25.59/ADS.