Germany-based MorphoSys and Belgian firm Galapagos have announced that dosing of human monoclonal antibody MOR106 in healthy volunteers has started in a Phase 1 study.
MOR106 was jointly discovered by MorphoSys and Galapagos and has a new mode of action with potential application in inflammation.
The main objective in the randomised, double-blind, placebo-controlled study conducted in a single centre in Belgium is to assess the safety and tolerability of single doses of MOR106.
The study includes around 56 healthy volunteers and evaluates single ascending doses (SAD) administered as intravenous infusion.
The Phase 1 study is also characterised by its adaptive design, which allows the initiation of a subsequent multiple ascending dose (MAD) study in patients, depending on the outcome of the SAD study in healthy volunteers.
Secondary objective of the study is to characterise the pharmacokinetic profile of MOR106 and observe the occurrence of anti-drug antibodies as a measure of immunogenicity with MOR106.
Results of the complete study, including the potential subsequent MAD part in patients, are expected to come in the second half of next year.
MorphoSys chief development officer Arndt Schottelius said: "MOR106 is MorphoSys’s fifth proprietary antibody programme 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 programme also reflects the high value of our ongoing collaboration with Galapagos."
MorphoSys noted that while developing MOR106, it provided its Ylanthia antibody technology to generate fully human antibodies directed against the target and Galapagos provided the disease-related biology such as cellular assays.
Both Galapagos and MorphoSys expect to continue to equally share the research and development costs of MOR106, and all future revenues.