I-Mab has concluded subject enrolment in the Phase III TALLER clinical trial to analyse eftansomatropin alfa (TJ101) a weekly therapy to treat pediatric growth hormone deficiency (PGHD) in China.
The company expects final results from the trial next year and will submit an application seeking a Biologics License Application (BLA).
The multicentre, randomised, open-label, active-controlled trial enrolled 168 participants in China.
It will analyse the safety, efficacy and pharmacokinetics (PK) of eftansomatropin alfa in PGHD patients versus Norditropin, a daily rhGH available in the Chinese market.
The annual height velocity is the primary endpoint of the trial.
A highly differentiated long-acting recombinant human growth hormone, eftansomatropin alfa elicits the production of insulin-like growth factor 1 (IGF-1) in the liver.
IGF-1 has growth-stimulating effects on various tissues, including osteoblast and chondrocyte activities that induce bone growth.
I-Mab president Dr Andrew Zhu said: “We are excited by having achieved this important milestone as we are now so close to offering this differentiated therapy to patients.
“Eftansomatropin alfa provides a convenient weekly treatment option in the current growth hormone market that is dominated by daily injectables.
“We look forward to advancing this study at full speed towards registration.”
In various priorly concluded clinical trials, the safety, tolerability and efficacy of eftansomatropin alfa were well demonstrated.
In November last year, the company entered a strategic partnership with Jumpcan Pharmaceutical to expedite the development, production and marketing of eftansomatropin alfa in mainland China.
