VISEN Pharmaceuticals announced positive top-line results from its pivotal phase 3 trial, a randomized, open-label, active-controlled trial that compared lonapegsomatropin, a once-weekly administered long-acting drug that delivers unmodified growth hormone, to a daily human growth hormone in children with growth hormone deficiency in China.
SHANGHAI, May 23, 2022 /PRNewswire/ -- VISEN Pharmaceuticals, an innovative biopharmaceutical company focused on endocrine diseases, today announced positive top-line results from its pivotal phase 3 trial, a randomized, open-label, active-controlled trial that compared lonapegsomatropin (TransCon hGH), a once-weekly administered long-acting drug that delivers unmodified growth hormone, to a daily human growth hormone (hGH) in children with growth hormone deficiency (GHD) in China.
“The trial met its primary objective, demonstrating that lonapegsomatropin was observed to be non-inferior and, additionally, superior to the daily growth hormone on the primary endpoint of annualized height velocity (AHV) at 52 weeks. The AHV for lonapegsomatropin was significantly greater than the daily hGH (p=0.0010).” said Pony LU, CEO and Board Member of VISEN Pharmaceuticals.
Top-line results from the trial indicate that lonapegsomatropin was well-tolerated and with comparable safety to daily growth hormone. The safety profile of lonapegsomatropin in Chinese children with GHD was consistent with global data reported previously.
VISEN Pharmaceuticals plans to submit clinical data as part of its Biologic License Application (BLA) to the National Medical Products Administration (NMPA) when all preparation works are completed.
VISEN Pharmaceuticals has exclusive rights to develop, manufacture and commercialize lonapegsomatropin in Greater China. The drug is globally developed by Ascendis Pharma A/S and has been approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for pediatric growth hormone deficiency in August 2021 and January 2022, respectively.
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