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Amolyt Pharma to Initiate P-III Clinical Trial of Eneboparatide for the Treatment of Hypoparathyroidism

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Amolyt Pharma

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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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