– Data from subjects with available dual energy x-ray absorptiometry (DXA) scans demonstrated stabilization of BMD, in alignment with observed bone turnover markers previously reported –
COPENHAGEN, Denmark, Sept. 22, 2021 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (NASDAQ:ASND), a biopharmaceutical company using its innovative TransCon™ technologies to potentially create new treatments to make a meaningful difference in patients’ lives, today announced 58-week BMD data from central lab reading in the PaTH Forward Trial, a global phase 2 trial of its investigational product candidate TransCon PTH in adult subjects with hypoparathyroidism (HP).
“HP patients, compared to people with normal parathyroid function, have insufficient parathyroid hormone (PTH) levels and low rates of PTH-driven skeletal remodeling, resulting in above-average bone mineral density and potentially an increased risk of fractures and other negative health effects,” said Aimee Shu, M.D., Ascendis Pharma’s Vice President of Clinical Development, Endocrine Medical Sciences. “We designed TransCon PTH as a once daily injection to restore physiologic levels of PTH, 24-hours a day. In PaTH Forward, mean BMD Z-scores, which parallel serum markers of bone turnover, trended towards stabilization and continued normalization at 58 weeks. We believe this is an indicator that TransCon PTH has the potential to be able to normalize calcium metabolism in the body over time.”
About the Week 58 Analysis
BMD was measured with non-invasive DXA, a low-radiation exposure technology widely used to identify individuals with bone fracture risk. Results were read and reported by a central lab.
| Mean Bone Mineral Density Z-scores by DXA* | ||||
| Anatomic region | n | Baseline | Week 26 | Week 58 |
| Lumbar spine (L1-L4) | 42 | 1.6 | 1.0 | 0.9 |
| Femoral neck | 43 | 1.0 | 0.5 | 0.5 |
| Total hip | 43 | 1.0 | 0.6 | 0.5 |
| Forearm/ 1/3 radius | 41 | 0.3 | 0.3 | 0.3 |
*From central lab reading
