I-Mab Biopharma (IMAB) Reports First Patient Dosed in China Phase 3 Study of Eftansomatropin Alfa in Pediatric Patients with Growth Hormone Deficiency
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I-Mab (NASDAQ: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the first patient has been dosed in the phase 3 pivotal trial (TALLER) for eftansomatropin alfa (also known as TJ101) as a weekly treatment for pediatric growth hormone deficiency (PGHD) in China.
Eftansomatropin alfa is an innovative long-acting recombinant human growth hormone (rhGH) with a novel molecular format utilizing Genexine's patented half-life extension hyFc® fusion technology. Most rhGHs have to be injected daily, which often hampers patient compliance and can adversely affect the clinical outcomes. Because of its unique features, eftansomatropin alfa may have long-term safety advantages over the conventional pegylated rhGH drugs, and its longer-acting regimen may offer advantages over daily injections. In the previous clinical trials, including a phase 2 study in Europe, eftansomatropin alfa was demonstrated to be safe and well-tolerated, and the clinical efficacy of weekly or biweekly regimens was comparable to that of the daily injected rhGH (genotropin).
"We look forward to the start of this pivotal trial. A successful result would have significant implications in the quality of life of the patients," said Professor Xiaoping Luo, a national thought leader in PGHD, principal investigator of the study and chairman of the Department of Pediatrics at Wuhan Tongji Hospital.
"In China where there are more than 3.4 million children with growth hormone deficiency and only a small percentage of them receiving treatment. I-Mab is well positioned to address this significant unmet need," said Dr. Joan Shen, CEO of I-Mab. "With the initiation of this pivotal trial, we hope to bring a highly differentiated growth hormone replacement therapy to our children."
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