Amolyt Pharma to Initiate P-III Clinical Trial of Eneboparatide for the Treatment of Hypoparathyroidism
Shots:
- Following an end of the P-II meeting with the US FDA, the company will initiate the P-III trial (Calypso) of eneboparatide vs PBO in a ratio (2:1) in 165 patients. The results are expected at the end of 2024
- The study's primary efficacy EPs are the proportion of patients with albumin-adjusted serum calcium within the normal range & independence from SoC after 24wks. The 2EPs incl. the normalization of 24hr. urinary calcium in patients with hypercalciuria at baseline & evaluation of PROs that reflect symptoms related to physical & cognitive function & impact on QoL
- The exploratory EPs evaluate the quantity & quality of the bone using high-resolution peripheral quantitative CT scanning & DXA scanning. All patients will receive eneboparatide in an OLE phase for an additional 28wks, following the initial 24wks.
Ref: Globenewswire | Image: Amolyt Pharma
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