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Ascendis Pharma's TransCon PTH Provides Durable Benefit, Is Well Tolerated Even After One Year Treatment In Hypoparathyroidism

05/11/2021 08:17
  • Ascendis Pharma A/S (NASDAQ: ASND) has announced preliminary 58-week results from the continuing open-label extension (OLE) portion of the Phase 2 PaTH Forward Trial evaluating TransCon PTH in adult subjects with hypoparathyroidism (HP).
  • Key Findings of the Preliminary OLE Results:
    • Fifty-eight subjects continue in the open-label extension beyond 58 weeks as of May 7.
    • Data showed established physiologic calcium metabolism based upon normalization of 24-hour urine calcium excretion and a downward trend toward mid-normal levels in bone markers without using therapeutic calcium and vitamin D supplementation.
    • No treatment-related serious or severe adverse events occurred, and no treatment-emergent adverse events led to discontinuation of the study drug.
  • In addition to PaTH Forward, Ascendis Pharma is conducting the PaTHway Phase 3 trial in North America and Europe, evaluating the safety, tolerability, and efficacy of TransCon PTH.
  • Topline results are expected by the end of this year.
  • TransCon PTH is an investigational once-daily long-acting prodrug of parathyroid hormone (PTH[1-34]) designed to restore PTH at physiologic levels 24 hours each day.
  • Price Action: ASND shares closed 2% lower at $130.07 on Monday.