MorphoSys AG, a late-stage, biopharmaceutical company, and Galapagos NV, a clinical-stage biotechnology company, announced that the first patient has been enrolled in IGUANA, a phase 2 study with MOR106, an investigational antibody directed against IL-17C, in atopic dermatitis patients.

At least 180 patients with moderate-to-severe atopic dermatitis (AD) are planned be treated over a 12-week period with one of three different doses of MOR106 (1, 3 or 10 mg/kg) or placebo using two different dosing regimens in this phase 2 trial in multiple centers across Europe. The placebo controlled, double-blind study will evaluate the efficacy, safety and pharmacokinetics (PK) of MOR106. Dosing at 2 or 4-week intervals will be evaluated over the 12-week treatment period, followed by a 16-week observation period. The primary objective will be assessed by the percentage change from baseline in Ecsema Area and Severity Index (EASI) score at week 12.

"Moderate-to-severe AD is a chronic, debilitating disease affecting millions of patients worldwide," said Dr. Malte Peters, chief development officer of MorphoSys AG. "We see a clear unmet medical need for additional safe and efficacious treatment options and we are looking forward to further developing MOR106 for these patients in the phase 2 trial we have now initiated together with our partner Galapagos."

"The IGUANA trial is aimed at providing a robustly supported data set on MOR106 in atopic dermatitis patients. We look forward to seeing what this IL-17C mechanism of action can bring to a larger trial population for longer treatment duration," said Dr. Piet Wigerinck, chief scientific officer of Galapagos.

MOR106 was generated using MorphoSys's Ylanthia antibody platform and is based on a target discovered by Galapagos. IL-17C is a cytokine expressed preferentially in the skin and which has been implicated in dermal inflammation and shown to be distinct from other members of the IL-17 cytokine family. MOR106 is the first publicly known human monoclonal antibody directed against IL-17C in clinical development worldwide. MOR106 is an investigational drug and its safety and efficacy are yet to be established.

Clinical data of a MOR106 phase 1 trial in AD patients were presented at the American Academy of Dermatology (AAD) conference in February 2018 in San Diego. After 4 infusions in weekly intervals, MOR106 showed preliminary signs of efficacy (5 out of 6 patients responded at the highest dose) and was generally well tolerated

Atopic dermatitis (AD), the most severe and common type of ecsema, is a chronic relapsing inflammatory skin disease that causes severe itch, dry skin and rashes, predominantly on the face, inner side of the elbows and knees, and on hands and feet. Scratching of the affected skin leads to a vicious cycle causing redness, swelling, cracking, scaling of the skin and an increased risk of bacterial infections. Lichenification, thickening of the skin, is characteristic in older children and adults. The National Ecsema Association estimates that AD affects over 30 million Americans or up to 25% of children and 2-3% of adults. 60% of AD patients are diagnosed in the first year of life, and 90% of patients have a disease onset before age five. Symptoms commonly fade during childhood, however, approximately 10-30% of the patients will suffer from AD for life. A smaller percentage first develop symptoms as adults.

MOR106 is an investigational fully human IgG1 monoclonal antibody designed to selectively target IL-17C, currently being developed for treatment of inflammatory diseases. MOR106 arises from the strategic discovery and co-development alliance between Galapagos and MorphoSys, in which both companies contribute their core technologies and expertise. Galapagos has provided the disease-related biology including cellular assays and targets discovered using its target discovery platform. MorphoSys has contributed its Ylanthia antibody technology to generate fully human antibodies directed against the target and contributes full CMC development of this compound. Galapagos and MorphoSys equally share research and development costs, as well as all future economics.