Benzinga | May 11, 2021 08:17AM EDT

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

* 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.