Ascendis' Hypoparathyroidism Candidate Shows Durable Benefit At 84 Weeks

Ascendis' Hypoparathyroidism Candidate Shows Durable Benefit At 84 Weeks
  • Ascendis Pharma A/S ASND announced topline results from Week 84 of its Phase 2 PaTH Forward Trial of its TransCon PTH candidate hypoparathyroidism (HP). 
  • Hypoparathyroidism is a condition in which the body produces abnormally low levels of PTH, the key to regulating and maintaining a balance of two calcium and phosphorus.
  • TransCon PTH is an investigational once-daily prodrug of parathyroid hormone (PTH) designed to restore physiologic levels of PTH 24 hours a day. 
  • The week 84 data showed that subjects treated with TransCon PTH had mean serum calcium levels and urinary calcium excretion that remained stable and normal.
  • Most subjects (93%) continued to be free from taking active vitamin D and were taking less than 600 mg/day of calcium supplements.
  • TransCon PTH was well-tolerated at all doses administered. 
  • No treatment-related severe adverse events occurred, and no treatment-emergent adverse events led to the discontinuation of the study drug.
  • The Company will share topline Phase 3 data in Q1 of 2022 and, if positive, plan to complete a marketing application submission to the FDA in mid-2022.
  • Related: See Why Ascendis Pharma Stock Is Shining On Thursday.
  • Price Action: ASND shares closed at $148.64 on Thursday.

Posted In: BriefsPhase 2 TrialBiotechNewsHealth CareFDAGeneral