New post hoc analysis showed substantial improvement in observed estimated glomerular filtration rate (eGFR), in TransCon PTH-treated adults with hypoparathyroidism

TransCon PTH (palopegteriparatide) is an investigational prodrug of parathyroid hormone (PTH 1-34) administered once daily designed to provide sustained release of active PTH within the physiological range for 24 hours per day in adult patients with hypoparathyroidism.

“Chronic kidney disease is one of the most consequential complications of chronic hypoparathyroidism and its treatment with conventional therapy. Diminished kidney function is associated with its own set of complications, including hypertension, edema, and weakness,” said Dr. Aliya Khan, M.D., Clinical Professor of Medicine at McMaster University and Director of the Calcium Disorders Clinic at McMaster University Medical Center. “The observations in the post hoc analysis of the PaTHway Trial, suggesting that treatment with TransCon PTH reverses impaired kidney function in patients with hypoparathyroidism, further substantiating the promise for a major improvement in treatment opportunities and outcomes for people living with hypoparathyroidism.”

In the Phase III PaTHway Trial, mean baseline eGFR was 67.3 and 72.7 mL/min/1.73m for subjects randomized to TransCon PTH and placebo, respectively. At Week 26, patients treated with TransCon PTH experienced a mean increase in eGFR of 7.9 mL/min/1.73m compared to baseline (p<0.0001) while those on placebo experienced a mean decrease in egfr of -1.9 ml min 1.73m2 compared to baseline (p="0.3468)." by week 52, patients treated with transcon pth, including those crossing over from placebo, experienced a mean increase in egfr of 8.9 ml min 1.73m compared to baseline (p><0.0001). the improvement at week 52 was even greater, with patients with egfr lrss then 60 at baseline, the threshold for kidney dysfunction, experiencing a mean increase in egfr of 11.5 ml min 1.73m. among subjects with baseline egfr less then 60 ml min m (considered the threshold for impaired kidney function), approximately 50% were able to improve their egfr to greater than 60 ml min with transcon pth therapy.></0.0001).></0.0001)>

"We will continue to study this important data and topic, which suggests the potential of TransCon PTH to address physician and patient concerns about soft-tissue calcifications and decreased kidney function associated with conventional therapy,” said Aimee Shu, M.D., Vice President, Clinical Development, Endocrine & Rare Diseases at Ascendis Pharma. “In addition to reducing risk for patients, this could also help significantly reduce the healthcare burden associated with hypoparathyroidism. We look forward to presenting detailed results at an upcoming medical conference.”.