Ascendis Pharma A/S (NASDAQ: ASND) stock rose over 7% on November 29th, 2018 (as of 10:58 am GMT-5 ; Source: Google finance) after the company announced positive preliminary results from a phase 1 trial of TransCon CNP. These results showed TransCon CNP provided continuous exposure to C-type natriuretic peptide (CNP) with a pharmacokinetic profile designed to maximize efficacy with once-weekly dosing. Additionally, the mean resting blood pressure and heart rate were unchanged from predose levels at all time points in all cohorts. Based upon these results, the company plans to initiate a phase 2 program of TransCon CNP in pediatric subjects with achondroplasia in mid-2019.
ASND expanded the global footprint through the formation of VISEN Pharmaceuticals in Greater China. Earlier this month, the company had announced the VISEN partnership which provides ASND with a compelling upside opportunity in China. VISEN also expands the potential reach of the rare disease clinical programs into China, which has a larger population than the United States and Europe combined. And at the end of the third quarter, the company completed recruitment in the fliGHt trial, which brings the company up to more than 300 pediatric subjects enrolled in the TransCon Growth Hormone Phase 3 program. This was another key step to advance our long-acting growth hormone therapy towards patient as the company await readout of the Phase 3 heiGHt trial in the first quarter of 2019.
The company is on track to report top-line results in the first quarter of 2019 for the phase 3 heiGHt Trial, a randomized, open-label, active-control trial comparing once-weekly TransCon hGH with a daily growth hormone therapy in treatment-naïve pediatric subjects with growth hormone deficiency (GHD). Completed third independent safety committee review; to date, the observed aggregate data from the heiGHt Trial continue to indicate a safety profile for TransCon hGH that is consistent with the published safety profile of the active comparator.
Additionally, ASND has continued planning for initiation of a phase 2 trial in the first quarter of 2019 to evaluate TransCon PTH, a long-acting prodrug of parathyroid hormone (PTH), in subjects with hypoparathyroidism. Final results of a phase 1 trial reinforced the potential of TransCon PTH to replace and restore PTH to physiologic levels for 24 hours per day.
Meanwhile, for the third quarter, Ascendis Pharma reported a net loss of €34.0 million compared to a net loss of €33.9 million for the same period in 2017.