MorphoSys Licensing Partner GSK Starts Phase II Study

MorphoSys AG recently announced its licensing partner GlaxoSmithKline (GSK) has initiated a Phase II clinical study to investigate the effectiveness and safety of GSK3196165 (previously known as MOR103) in patients with inflammatory hand osteoarthritis (HOA). GSK3196165 is a monoclonal antibody against GM-CSF (granulocyte-macrophage colony-stimulating factor) cytokine, a target molecule for a broad range of inflammatory diseases. The antibody was discovered and engineered by MorphoSys using its HuCAL technology and outlicensed to GSK in 2013.

The European multi-center Phase II double-blind, placebo-controlled study will investigate the efficacy and safety of subcutaneous injections of GSK3196165 in 40 adult subjects with inflammatory hand osteoarthritis. The main objective of the study is to assess the efficacy potential of GSK3196165 on pain in inflammatory HOA. Secondary objectives include the assessment of safety and pharmacokinetics of GSK3196165.

Osteoarthritis is a condition that causes damage to the surface of joints in the body leading to joint pain and stiffness. In some patients it can adversely affect work and normal daily activities.

“We are delighted to see our licensing partner GSK moving GSK3196165 into a clinical Phase II study designed to assess its efficacy and safety in inflammatory hand osteoarthritis, a chronic disease with high medical need,” said Arndt Schottelius, Chief Development Officer of MorphoSys AG. “In addition to an ongoing Phase II study in rheumatoid arthritis, this is GSK’s second clinical study with GSK3196165 in a therapeutically highly relevant indication. We are excited that our partner is further broadening the clinical development program with this HuCAL antibody discovered by MorphoSys.”

In 2013, MorphoSys outlicensed MOR103 (now: GSK3196165) to GSK. Under the terms of the agreement, GSK assumed responsibility for all subsequent development and commercialization activities of the drug candidate. MorphoSys received an immediate upfront payment of EUR 22.5 million. On achievement of certain developmental, regulatory, commercial, and sales-based milestones, MorphoSys will be eligible to receive additional payments from GSK of up to EUR 423 million to total, in addition to tiered, double-digit royalties on net sales. GSK3196165 is a HuCAL-derived antibody against GM-CSF (granulocyte-macrophage colony-stimulating factor) cytokine, a target molecule for a broad range of inflammatory diseases. GSK is currently developing GSK3196165 in two clinical trials in two indications – a Phase IIb study in rheumatoid arthritis (initiated in Q3 2015) and a phase IIa study in inflammatory hand osteoarthritis (started now). MorphoSys has concluded a Phase I study in healthy volunteers, a Phase I/II study in mild-to-moderate rheumatoid arthritis as well as a Phase Ib study in multiple sclerosis.

MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare.

Together with its pharmaceutical partners, MorphoSys has built a therapeutic pipeline of more than 100 human antibody drug candidates for the treatment of cancer, rheumatoid arthritis, and Alzheimer’s disease, to name just a few. With its ongoing commitment to new antibody technology and drug development, MorphoSys is focused on making the healthcare products of tomorrow. For more information, visit http://www.morphosys.com.