Phase III CTJ101PGHD301 study of GX H9 meets primary endpoint in growth hormone deficiency
Genexine announced positive topline results from the multi-center, randomized, open-label, active-controlled pivotal phase III study (CTJ101PGHD301) being conducted in China to evaluate the efficacy and safety of eftansomatropin alfa (Genexine’s proprietary long-acting growth hormone, also known as GX-H9) in children with growth hormone deficiency
The study being conducted by Genexine’s partner in China, I-Mab, met its primary endpoint of annualized height velocity (AHV) at week 52 and demonstrated that eftansomatropin alfa was non-inferior to Norditropin. Eftansomatropin alfa was given by weekly injection vs. Norditropin given by daily injection. The mean AHV was 10.76 (cm/year) for eftansomatropin alfa vs. 10.28 (cm/year) for Norditropin, with a difference of 0.47 [95% CI -0.06,1.00] and non-inferiority p-value <0.0001. eftansomatropin alfa was well tolerated and no drug discontinuation was reported due to treatment related adverse events. the safety profile of eftansomatropin alfa was comparable to norditropin. the company is planning to file a bla submission in china in 2024.
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