06 Sep 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Generon (Shanghai)has initiated phase I clinical trial for F-652 in Australia. F-652 is a recombinant protein containing a human interleukin-22 (IL-22) dimer. The current phase I study is to evaluate the safety and pharmacokinetics (PK) profile and identify biomarkers for F-652 in healthy volunteers.
In pre-clinical studies, F-652 demonstrated expected bioactivity in vitro and in vivo with excellent PK and safety profile. The company is conducting a first-in-man (FIM) trial in healthy volunteers to evaluate the safety and PK properties of F-652. F-652 could potentially address unmet medical needs in several inflammatory diseases. For example, F-652 (IL-22) helps liver regenerate after injury by promoting hepatocyte survival and proliferation.
"There is a tremendous amount of published research regarding IL-22. I am very pleased to see Generon developing F-652 therapeutically for clinical use," said Dr Gregory Gores, Chair of Gastroenterology and Hepatology at the Mayo Clinic, Rochester, MN, USA.
Commenting on the initiation of the phase I trial, Dr Yu-Liang Huang (CEO of Generon) says, "We are extremely excited about the F-652 program. Neither IL-22 nor IL-22-related recombinant protein has been studied in human clinical trials, either as agonist or antagonist. This is another important milestone for our science and innovation. We are very proud that we have established a platform in China for developing a first-in-class biological drug from the bench-side to the bed-side."