I-Mab a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced the completion of patient enrollment in a Phase 3 clinical trial (TALLER) of highly differentiated long-acting recombinant human growth hormone eftansomatropin alfa (also known as TJ101), which is being investigated as a weekly treatment for pediatric growth hormone deficiency (PGHD) in China. The primary endpoint is annual height velocity. In China, only a small percentage of children with growth hormone deficiency are receiving treatment, which presents a significant unmet medical need. It is a remarkable accomplishment by I-Mab for successfully completing the patient enrollment on schedule amid the covid pandemic," commented Professor Xiaoping Luo, a national thought leader in PGHD, principal investigator of the TALLER study and chairman of the Department of Pediatrics at Wuhan Tongji Hospital.
TALLER is a multi-center, randomized, open-label, active-controlled phase 3 clinical study (NCT04633057) that has enrolled 168 patients in China. The study aims to evaluate the efficacy, safety, and pharmacokinetics (PK) of eftansomatropin alfa in PGHD, as compared to Norditropin
