Phase III Trial – BiotechReality – Information Intelligence System for Biopharma

In people with chronic hypoparathyroidism (HypoPT), eneboparatide (AZP-3601), an experimental parathyroid hormone (PTH) receptor 1 agonist, achieved its primary endpoint with statistical significance at 24 weeks when compared to a placebo, according to high-level results from the CALYPSO Phase III trial. Normalization of albumin-adjusted blood calcium levels and independence from oral calcium treatment and active vitamin D constitute the main objective. HypoPT is an uncommon endocrine condition marked by poor control of blood calcium and phosphate levels that is brought on by a PTH shortage. Clinical symptoms, such as adverse effects on the kidney and bone, may result from this dysregulation of PTH's physiological function. One One of the most prevalent uncommon disorders, hypoPT affects about 200,000 persons in the US and the EU, with about 80% of those affected being women. People living with HypoPT, a rare endocrine disease, are often at increased risk of hypercalciuria, osteopenia and osteoporosis, and these results from the CALYPSO trial underscore eneboparatide’s potential to be another option for these patients. We look forward to reviewing clinical results at 52 weeks to fully characterise the risk-benefit profile. Marc Dunoyer The tolerance to eneboparatide was good. All patients receive eneboparatide for the ongoing long-term extension period, which lasts for 52 weeks, following the 24-week randomized treatment period. At 52 weeks, all safety and efficacy data will be examined. Alexion intends to submit these findings at upcoming medical conferences and distribute them to international health authorities. Hypoparathyroidism The underactivity of the four tiny parathyroid glands, which are situated behind the thyroid and produce parathyroid hormone (PTH), is an uncommon symptom of hypoparathyroidism. PTH is essential for controlling blood levels of calcium and phosphorus. The delicate balance of these minerals is upset when these glands generate insufficient PTH, causing calcium levels to fall (hypocalcemia) and phosphorus levels to rise (hyperphosphatemia). Numerous symptoms, such as tingling, cramping in the muscles, exhaustion, and in extreme situations, seizures, can result from this imbalance. CALYPSO An international Phase III, double-blind, randomised, placebo-controlled, multicenter trial called CALYPSO was established to assess the safety and effectiveness of eneboparatide in treating adults with chronic hypoparathyroidism. Eneboparatide or a placebo was randomly assigned to 202 patients who were receiving standard therapy, which included active vitamin D and oral calcium supplements, in a 2:1 ratio. After 24 weeks of treatment, the percentage of patients who attain albumin-adjusted serum calcium within the normal range and independence from standard of care constitutes the primary efficacy outcome. Normalization of 24-hour urine calcium in patients with hypercalciuria at baseline and evaluation of patient-reported outcomes that include physical symptoms and quality of life impact are the main secondary efficacy objectives. Also Read: Amgen Released Phase 3 MINT Trial Data Evaluating the Efficacy and Safety of UPLIZNA® (inebilizumab-cdon) Eneboparatide (AZP-3601) An experimental parathyroid hormone (PTH) receptor 1 agonist called eneboparatide (AZP-3601) is used to treat persistent hypoparathyroidism (HypoPT). In order to control the symptoms of HypoPT, it is made to bind with high affinity to a particular conformation of the PTH receptor 1 and restore PTH function while maintaining bone and kidney health. For the treatment of HypoPT, eneboparatide has received orphan status from the European Medicines Agency and fast track designation from the US Food and Drug Administration. Source: AstraZeneca Last Modified:

Tag: Phase III Trial

AstraZeneca Released Satisfactory Results of 24 Weeks CALYPSO Phase III Trial for Eneboparatide

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