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VISEN Pharmaceuticals, an innovative biopharmaceutical company focused on endocrine-related therapeutics, announced on January 6 that its Phase 3 clinical trial (PaTHway China trial), an innovative drug in research, has completed a double-blind treatment period on January 4, 2023, and will soon undergo primary endpoint analysis
。 Paroperteitriparatide is administered once daily to restore 24-hour physiological levels
of parathyroid hormone (PTH [1-34]) in adult patients with hypoparathyroidism (hypoparathyroidism, HP).
The PaTHway China trial is a randomized, double-blind, placebo-controlled, parallel-design, multicenter Phase 3 clinical trial designed to evaluate the potential
of paropeitriparatide as parathyroid hormone replacement therapy.
To assess the safety, tolerability, and efficacy of once-daily subcutaneous paropeiparatide in adults with hypoparathyroidism, the primary efficacy endpoint was to assess the effectiveness
of serum calcium (sCa) in the normal range (8.
3 to 10.
6 mg/dL) in patients with paraparathyroid hypothyroidism receiving paroperteiparatide when conventional calcium and active vitamin D therapy were discontinued.
The trial was approved by the National Medical Products Administration (NMPA) of China to conduct research in China on May 31, 2021, and all subjects were successfully enrolled
on June 16, 2022.
Hypoparathyroidism is the last endocrine hormone deficiency disorder
for which true hormone replacement therapy has not been achieved.
This is a rare endocrine disorder characterized by insufficient or impaired activity of parathyroid hormone (PTH) and disruption of calcium-phosphorus homeostasis, resulting in low blood calcium (sCa) and elevated
blood phosphorus (sP).
Conventional calcium and active vitamin D therapy is not effective in addressing the short-term symptoms, long-term complications, and quality of life of hypoparathyroidism, and may result in impaired
renal function.
The once-daily dosing design of paroperteiparatide can provide continuous exposure of parathyroid hormone within the normal physiological concentration range, and if approved, it is expected to become the first hormone replacement therapy
for parathyroidism in China.
Mr.
Anbang Lu, CEO and Executive Director of Veson Pharmaceutical, said, "The end of the double-blind phase 3 clinical trial of paroperteiparatide in China means that we are one step
closer to the success of the first hormone replacement therapy research for parathyroid hypothyroidism in China.
At present, Weisheng Pharmaceutical will proceed with the main endpoint analysis of the study and submit a marketing application
to the NMPA as soon as possible after completing all preparatory work.
We look forward to bringing new treatment options to Chinese patients with parathyroidism as soon as possible and alleviating their long-term suffering
.
"
Vestion Pharma introduced and developed paropetide from Ascendis Pharma, which was granted priority review status by the US FDA in 2022, and Ascendis said that the US FDA expects to complete the review on April 30, 2023 [1].
In addition, Ascendis Pharma has submitted a marketing application for paroperteitriparatide to the European Medicines Agency (EMA) [2].
[1] https://investors.
ascendispharma.
com/news-releases/news-release-details/fda-accepts-priority-review-ascendis-pharmas-nda-transcontm-pth?fbclid=IwAR3eEnJy3Udn5_-x5yGvmb2FpIzQM_jSin7RJjHmtfK8Uw34VsAs2HMnAmA
[2] https://investors.
ascendispharma.
com/news-releases/news-release-details/ascendis-pharma-submits-marketing-authorisation-application
