South Korea's Genexine's Long-Acting Growth Hormone Meets Phase 3 Endpoint

31 August 2023 | Thursday | News

Genexine (KOSDAQ:095700, CEO Neil Warma), a publicly traded, clinical-staged Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, today announced positive topline results from the multi-center, randomized, open-label, active-controlled pivotal phase 3 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.
Image Source : Public Domain

Image Source : Public Domain

  • Phase 3 clinical trial in China meets primary endpoint
  • On track to file BLA in China in 2024

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.

“We are pleased with the results from this registration trial as this demonstrates clear safety and efficacy in this potential best-in-class drug to treat children with growth hormone deficiency,” said Neil Warma, Genexine President and CEO. “This is a significant milestone for Genexine as we demonstrate our ability to bring our novel products to market and the value of our proprietary long-acting hyFc® platform. We are excited to be preparing to submit the BLA in 2024 and advancing this product to market and to patients in China. We remain committed to our efforts to commercialize our leading products in various key markets.”

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