Core results of TransCon parathyroid global Phase II clinical study announced

Ascendis Pharma announced on April 19, 2020 that positive results were achieved in a 4-week fixed-dose double-blind phase of a global Phase II clinical study (PaTH Forward Study) that assessed the safety, tolerance and effectiveness of TransCon parathyroid ism in adult patients with parathyroid degeneration (HP)TransCon parathyroidin, a pre-drug-based long-acting parathyroid (PTH), is planned to develop an alternative treatment for adult parathyroid degenerative degenerative disorder, which is designed to provide physiological replacement PTH 24 hours a day to address both short-term symptoms and long-term complications of HPa total of 59 subjects, using ready-to-use pre-filled injection pens (planned for use after marketing), were randomly double-blinded for 4 weeks with a fixed dose of TransCon parathyroid or placebo treatment of 15, 18 or 21 micrograms per dayTransCon parathyroidin was well tolerated in all dose groups and there were no serious or severe adverse events in any dose groupNo treatment-related adverse events (TEAEs) caused the study drug to be discontinued, and the overall incidence of TEAEs between TransCon parathyroid and placebo was comparableIn addition, there was no loss of subjects during the 4-week fixed dose of treatmentin the protocol analysis set (n s 57), in the 100% maximum dose group (21 micrograms/day) and 82% of all dose groups of subjects, TransCon parathyroidism can be an alternative to conventional treatment, resulting in active vitamin D deactivation and calcium supplementation less than 500 mg per dayResults from the fixed dose phase of PaTH Forward show edgyendin can increase blood calcium levels within 4 weeks, making it possible to discontinue active vitamin D and reduce the persistence of calcium supplementsWhile raising blood calcium, TransCon parathyroid itcane also reduces calcium excretion in the urine (by measuring calcium excretion score FECa) and can sustainably reduce the product of blood and calcium phosphorusIn the protocol analysis set, there was a significant statistical difference in the dose group of 21 micrograms per day per day at week 4 and all TransCon parathyroid dosing groups compared to the placebo group at the main compound endpoint (p 0.05)58 subjects continued to enter the open expansion phase of the study and were treated with an individualized TransCon parathyroid parathyroid maintenance dose (6 to 30 micrograms per day)Ascendis Pharma plans to report data on the six-month follow-up point sqin the third quarter of 2020Ascendis Pharma plans to work with global regulators to develop TransCon parathyroidin next step and file a regulatory filing to launch a Global Phase III clinical trial in North America, Europe and Asia in the fourth quarter of 2020Note: The original text has a limitation