- 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.
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