Entera Bio Completes Part 1 of a Phase 2 PK/PD Study in Hypoparathyroidism Patients
A second and final part of the study will evaluate selected dose regimens chosen based on part 1
“We are pleased to have completed the first part of the Phase 2 study for hypoparathyroidism on track with our timeline and look forward to announcing the results in the coming months,” stated Dr.
The Phase 2 trial is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of oral PTH (1-34) and Natpar®, an injectable PTH (1-84), in patients with hypoparathyroidism. In part 1 of the Phase 2 study, ten patients completed two treatment visits, including three overnight stays each during which patients were administered various EB612 regimens or Natpar. Throughout the treatment visits, patients were continuously monitored and various tests were performed, including blood and urine sampling. An analysis of the part 1 data is expected within two to three months.
The second and final part of the study will evaluate selected dose regimens chosen based on the results of the trial’s first part. The results from this Phase 2 PK/PD trial will provide input for the design of our anticipated pivotal clinical trial.
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Source: Entera Bio