On January 17, Weisheng Pharmaceutical (VISEN Pharmaceuticals) announced the first release of the major research data for its phase 3 key clinical trial of long-acting growth hormone (weekly preparation). The test targeted Chinese children with growth hormone deficiency (GHD), a prodrug administered once a week and releases unmodified growth hormone.
The results showed that the annualized growth rate (AHV) was 10.66 cm / year and 9.75 cm / year (0.91,95% confidence interval: 0.37-1.45, p=0.0010, respectively), achieving the main endpoint of the study, that is, growth propin was non-inferior to GH daily. According to the preset statistical test, the analysis of the main endpoint also confirmed that auxin is superior to growth hormone day preparation. Multiple preset sensitivity analyses confirmed the robustness of the results. The safety results showed that auxin was well tolerated and the safety characteristics were comparable to GH Day.
At present, most of the growth hormone marketed in China are short-acting preparations injected daily. Autoptropin is a new long-acting growth hormone introduced from Ascendis Pharma and developed based on the innovative "TransCon temporary connection" technology, which is only administered once a week. Following injection, the junctional structure was automatically cleaved at a specific rate and released from unmodified GH in a controlled manner. Weisheng's phase 3 key clinical trial is a randomized, open and positive controlled clinical trial for the treatment of growth hormone deficiency in children in China, led by Professor Luo Xiaoping, vice chairman of the Branch of Pediatrics of the Chinese Medical Association and director of the Pediatrics Department of Tongji Hospital of Huazhong University of Science and Technology.
When further interpreting the main research data, Professor Luo Xiaoping said: " From week 13, AHV was significantly higher in the lung culture auxin group than in the GH day preparation group. Week 52 (SDS) increased by 1.01 and 0.83 (p. = 0.0015), respectively, and the height SDS improvement in the group was more pronounced at week 13. The mean insulin-like growth-factor-1 (IGF-1) SDS was increased to the normal range and was relatively high in the 52 weeks of treatment group. IGF-1 is a polypeptide produced in the liver in response to growth hormone. Its physiological effects are mainly to stimulate chondrocyte proliferation, differentiation, and collagen synthesis. The enhancing / antagonistic system of GH-IGF enhances the anabolic effects of GH while attenuated the potential adverse effects of GH from gluconeogenesis and adipolysis."
Sheng pharmaceutical chief executive and executive director Mr Lu Anbang said: " according to the public data of listed products, culture autropin is the only confirmed contrast growth hormone day preparation superior long-acting products, announced today of the China phase 3 clinical trial of 52 weeks of key data, 'head to head' confirmed once a week culture aupin not inferior and superior in growth hormone day preparation, safety and growth hormone day preparation. This study is consistent with the results of the global critical phase 3 study (heiGHt study), showing that perprotropin has significant efficacy and good safety in children with GHD, and it is expected to provide a new long-acting growth hormone treatment option for Chinese pediatric patients."
The global clinical development of autropin outside Greater China is handled by Ascendis Pharma A / S, which has been approved by the US Food and Drug Administration (FDA) and the European Commission (EC) in August 2021 and January 2022, respectively.
