— 52-week results from the Phase 3 PaTHway Trial showed that the skeletal dynamics of adult patients with chronic hypoparathyroidism treated with TransCon PTH trended toward a new steady state closer to age-appropriate norms
— Bone turnover markers trended toward the normal reference ranges for sex and menopausal status and corresponded to smaller changes in bone mineral density (BMD) through Week 52
— Results were similar to trends in bone turnover markers and changes in BMD previously reported through Week 110 in the Phase 2 PaTH Forward Trial
COPENHAGEN, Denmark I October 16, 2023 I Ascendis Pharma A/S (Nasdaq: ASND) shared 52-week data from the open-label extension period of its ongoing Phase 3 PaTHway Trial of TransCon PTH (palopegteriparatide) showing that adults with chronic hypoparathyroidism, whose bones tend to be over-mineralized due to insufficient parathyroid hormone (PTH) exposure, trended toward a new skeletal steady state closer to age-appropriate norms with continued use of TransCon PTH. The results were consistent regardless of sex, menopausal status, or duration of disease and were consistent with results previously reported through Week 110 in the Company’s Phase 2 PaTH Forward Trial.
An oral presentation of the data was given today by Aliya Khan, M.D., Clinical Professor of Medicine at McMaster University and Director of the Calcium Disorders Clinic at McMaster University Medical Center, during ASBMR 2023, the annual meeting of the American Association of Bone & Mineral Research in Vancouver, BC, Canada.
Reflecting on the clinical data and its potential impact, Dr. Khan said “Treatment with TransCon PTH in this clinical trial showed the positive physiological effects on bone, in patients treated for the full year as well as in those switching from placebo after the 26-week blinded period. These results underscore the importance of providing the missing hormone to address the significant impacts of hypoparathyroidism, including decreased bone remodeling leading to a dense, over-mineralized bone structure.”
TransCon PTH (palopegteriparatide) is an investigational prodrug with sustained release of active parathyroid hormone (PTH [1-34]) administered once daily. On September 14, 2023, TransCon PTH received a positive CHMP opinion recommending approval in the European Union for the treatment of adults with chronic hypoparathyroidism. TransCon PTH is also in development in the United States and Japan.
PaTHway is an ongoing Phase 3 double-blind, placebo-controlled trial of 82 dosed adults with chronic hypoparathyroidism randomized 3:1 (TransCon PTH:placebo) treated for 26 weeks, followed by a 156-week open-label extension period.
Registered attendees of ASMBR 2023 conference can access the abstract, poster, and presentation (#1114) through the conference organizer’s website.
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Germany (Heidelberg and Munich) and the United States (Palo Alto and Redwood City, California, and Princeton, New Jersey). Please visit ascendispharma.com to learn more.
SOURCE: Ascendis Pharma
Post Views: 389
— 52-week results from the Phase 3 PaTHway Trial showed that the skeletal dynamics of adult patients with chronic hypoparathyroidism treated with TransCon PTH trended toward a new steady state closer to age-appropriate norms
— Bone turnover markers trended toward the normal reference ranges for sex and menopausal status and corresponded to smaller changes in bone mineral density (BMD) through Week 52
— Results were similar to trends in bone turnover markers and changes in BMD previously reported through Week 110 in the Phase 2 PaTH Forward Trial
COPENHAGEN, Denmark I October 16, 2023 I Ascendis Pharma A/S (Nasdaq: ASND) shared 52-week data from the open-label extension period of its ongoing Phase 3 PaTHway Trial of TransCon PTH (palopegteriparatide) showing that adults with chronic hypoparathyroidism, whose bones tend to be over-mineralized due to insufficient parathyroid hormone (PTH) exposure, trended toward a new skeletal steady state closer to age-appropriate norms with continued use of TransCon PTH. The results were consistent regardless of sex, menopausal status, or duration of disease and were consistent with results previously reported through Week 110 in the Company’s Phase 2 PaTH Forward Trial.
An oral presentation of the data was given today by Aliya Khan, M.D., Clinical Professor of Medicine at McMaster University and Director of the Calcium Disorders Clinic at McMaster University Medical Center, during ASBMR 2023, the annual meeting of the American Association of Bone & Mineral Research in Vancouver, BC, Canada.
Reflecting on the clinical data and its potential impact, Dr. Khan said “Treatment with TransCon PTH in this clinical trial showed the positive physiological effects on bone, in patients treated for the full year as well as in those switching from placebo after the 26-week blinded period. These results underscore the importance of providing the missing hormone to address the significant impacts of hypoparathyroidism, including decreased bone remodeling leading to a dense, over-mineralized bone structure.”
TransCon PTH (palopegteriparatide) is an investigational prodrug with sustained release of active parathyroid hormone (PTH [1-34]) administered once daily. On September 14, 2023, TransCon PTH received a positive CHMP opinion recommending approval in the European Union for the treatment of adults with chronic hypoparathyroidism. TransCon PTH is also in development in the United States and Japan.
PaTHway is an ongoing Phase 3 double-blind, placebo-controlled trial of 82 dosed adults with chronic hypoparathyroidism randomized 3:1 (TransCon PTH:placebo) treated for 26 weeks, followed by a 156-week open-label extension period.
Registered attendees of ASMBR 2023 conference can access the abstract, poster, and presentation (#1114) through the conference organizer’s website.
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Germany (Heidelberg and Munich) and the United States (Palo Alto and Redwood City, California, and Princeton, New Jersey). Please visit ascendispharma.com to learn more.
SOURCE: Ascendis Pharma
Post Views: 389
