MorphoSys Receives CTA Approval to Initiate Phase 1 Clinical Study for MOR103 Program
MorphoSys AG has announced that the regulatory authorities in the Netherlands have approved the clinical trial application (CTA) to initiate a phase 1 study of the HuCAL-derived antibody MOR103.
MorphoSys had submitted the clinical trial application in December 2007. In parallel, MorphoSys has received a manufacturing license from the Bavarian Government, allowing MorphoSys to release clinical trial material for MOR103 clinical studies as a sponsor.
MOR103 is a fully human HuCAL antibody directed against GM-CSF (granulocyte macrophage-colony stimulating factor), being developed in the area of inflammatory diseases, such as rheumatoid arthritis, where current treatment options are inadequate. Due to its diverse functions in the immune system, GM-CSF can be considered a target for a broad spectrum of anti-inflammatory therapies.
The phase 1 trial is a randomized, double-blind, placebo-controlled, single-ascending dose trial and will be conducted in healthy volunteers. The study will evaluate the safety and tolerability as well as pharmacokinetics of escalating doses of MOR103.
"We are very pleased to see our first proprietary drug candidate advance quickly into the clinic," commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG. "The smooth process and quick approval by the Dutch authorities illustrate the quality of our clinical trial application process and the strength of the underlying data package."