VISEN growth hormone deficiency trial results announced

growth hormone deficiency

VISEN Pharmaceuticals has published detailed clinical data from its pivotal phase 3 study of lonapegsomatropin, a long-acting prodrug of unmodified somatropin being investigated as a once-weekly injection in children with growth hormone deficiency (GHD) in China.

The data showed that lonapegsomatropin demonstrated an annualized height velocity (AHV) of 10.66 cm/year compared to 9.75 cm/year for the daily hGH at 52 weeks (treatment difference at 0.91 cm/year.

Further analysis showed that lonapegsomatropin had superior efficacy to the daily hGH. Multiple pre-set sensitivity analyses validated the robustness of these results.

During this trial, lonapegsomatropin was well tolerated with a safety profile comparable to daily hGH.

Currently, most of the commercially available growth hormone therapies in China are in the form of short-acting daily injections.

Lonapegsomatropin is in development in Greater China through license from Ascendis Pharma and uses Ascendis Pharma’s TransCon (transient conjugation) technology.

When injected, physiologic conditions in the body initiate the release of the active, unmodified somatropin in a predictable manner at a predetermined rate, releasing predictable levels of somatropin over the course of the week.

VISEN Pharmaceuticals’ pivotal Phase 3 trial was a randomized, open-label, active-controlled trial with children suffering from growth hormone deficiency in China led by Luo Xiaoping as the principal investigator. Xiaoping is the deputy director of the Pediatrics Commission of China Medical Association and director of the Pediatrics Department at Tongji Hospital affiliated to the Huazhong University of Science and Technology.

Pony LU, CEO and executive director of VISEN Pharmaceuticals, said: “According to publicly available data of marketed products in China, lonapegsomatropin is currently the only long-acting growth hormone demonstrated superiority to the daily treatment with the growth hormone somatropin. The pivotal 52-week data released today from the China phase 3 clinical trial demonstrated head-to-head that once-weekly lonapegsomatropin is non-inferiority and superior to daily hGH. The results are consistent with Ascendis Pharma’s global pivotal Phase 3 heiGHt Trial, and we look forward to offering a new long-acting growth hormone treatment option for Chinese patients.”

Lonapegsomatropin is globally developed by Ascendis Pharma A/S, who received U.S. Food and Drug Administration (FDA) and the European Commission (EC) approval for lonapegsomatropin in pediatric growth hormone deficiency in August 2021 and January 2022, respectively.

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