BerGenBio started testing has started testing anti-AXL therapeutic monoclonal antibody BGB149 with healthy volunteers in its fully own Phase I clinical trial.
This is BerGenBio’s second clinical stage drug development programme targeting AXL. The The Norwegian drugmaker siad BGB149 is the first functional blocking anti-AXL monoclonal antibody to enter clinical development.
The Phase I healthy volunteer trial BGB149-101 will enrol up to 36 subjects andinvestigate the safety, tolerability and pharmacokinetics of BGB149 following single dose administration.
Richard Godfrey, Chief Executive Officer of BerGenBio, said that Phase I study goes as planned, with BGB149 having cleared all required regulatory pre-clinical evaluations.
He further explained that this AXL functional blocking antibody is BerGenBio’s second drug candidate to enter clinical trials. He said: “(This is) An important milestone in expanding our pipeline of first-in-class AXL targeting drug candidates positioned to treat aggressive diseases with severe unmet medical need. We are expecting results from this Phase I trial in 2019 and are looking forward to announcing BGB149’s further clinical development strategy in the coming months.”