Galapagos and MorphoSys announce initiation of the IGUANA Phase 2 clinical trial with MOR106 in atopic dermatitis patients
01 May 2018 at 22:01 CET
Mechelen, Belgium and Planegg/Munich, Germany; 1 May 2018; 22.01 CET - Galapagos NV (Euronext & NASDAQ: GLPG) and MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that the first patient has been screened in IGUANA, a Phase 2 study with MOR106, an investigational antibody directed against IL-17C, in atopic dermatitis patients.
IGUANA - A MOR106 Phase 2 trial
At least 180 patients with moderate-to-severe atopic dermatitis (AD) are planned to 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 Eczema 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 robust dataset 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' 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 have not yet been established.
About MOR106 results of a Phase 1 study in atopic dermatitis (AD)
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, an improvement of at least 50% in the Eczema Area and Severity Index (EASI-50) was observed in 83% of patients (5 out of 6) at week 4 at the highest dose level of MOR106. The onset of activity occurred within two to four weeks, depending on the dose administered. Pooled data across all dose cohorts showed that AD patients treated with MOR106 achieved an EASI improvement compared to baseline of 58%, 62%, 72%, and 64% at week 4, 8, 12, and 14, respectively. For patients receiving placebo, the EASI improvement was 32%, 40%, 38%, and 50%. MOR106 was generally well tolerated in this trial. Any adverse drug reactions observed in relation to MOR106 were mild-to-moderate and transient in nature. No serious adverse events or infusion-related reactions were recorded (Thaçi et al., 2018, AAD).