Galapagos and MorphoSys initiate Phase 1 study
News Apr 08, 2016
Galapagos NV and MorphoSys AG have announced that dosing of MOR106 has been initiated in healthy volunteers in a Phase 1 study. MOR106 was jointly discovered by Galapagos and MorphoSys under their collaboration, and has a novel mode of action with potential application in inflammation.
The primary objective of the Phase 1 study is to evaluate the safety and tolerability of single doses of MOR106. The study is randomized, double-blind, placebo-controlled and conducted in a single center in at least 56 healthy volunteers in Belgium, evaluating single ascending doses (SAD) administered as intravenous infusion.
This Phase 1 study is characterized by its adaptive design, which enables the initiation of a subsequent multiple ascending dose (MAD) study in patients, depending on the outcome of the SAD study in healthy volunteers. The study’s secondary objective is to characterize the pharmacokinetic profile of MOR106 as well as monitor the occurrence of anti-drug antibodies as a measure of immunogenicity with MOR106.
Topline results of the complete study, including the potential subsequent MAD part in patients, are
expected in the second half of 2017. “The alliance with MorphoSys has produced a first-in-class candidate human monoclonal antibody,” said Piet Wigerinck, CSO of Galapagos. “MOR106 is the 10th Galapagos candidate with a new mode of action to be brought into the clinic.”
“We are delighted to see the first antibody program from our alliance with Galapagos entering the
clinical development stage. MOR106 is MorphoSys’s fifth proprietary antibody program in clinical
development and the first from our novel Ylanthia technology platform.
We are excited about the growing value and maturity of our development pipeline. The start of this very innovative clinical development program also reflects the high value of our ongoing collaboration with Galapagos”, commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.