durobinet schreef op 13 september 2018 22:06:
Galapagos and MorphoSys announce start of a Phase 1 subcutaneous bridging study with MOR106
13 September 2018 at 22:01 CET
Mechelen, Belgium and Planegg/Munich, Germany; 13 September 2018; 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) and MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; NASDAQ: MOR) announced today the initiation of a Phase 1 bridging study testing a subcutaneous formulation of MOR106, an investigational antibody directed against IL-17C.
This bridging study is a parallel-design Phase 1 clinical trial conducted in two parts. Part 1 is a single center, randomized, open-label study in healthy volunteers who will be treated with different single dose levels of MOR106 administered subcutaneously or intravenously. Part 2 is a multiple center, randomized, placebo-controlled, multiple dose study in patients with moderate to severe atopic dermatitis who will be treated subcutaneously for 12 weeks.
Safety and tolerability, pharmacokinetics (PK) and occurrence of anti-drug-antibodies after administration of MOR106 will be assessed as endpoints. In addition, the efficacy of MOR106 will be explored in subjects with moderate to severe atopic dermatitis.
"The start of the bridging study together with Galapagos with a subcutaneous formulation of MOR106 is an important milestone in its clinical development," commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "This route of subcutaneous administration is widely used for the treatment of chronic skin diseases, and we intend to evaluate it in this study with the goal of providing support for the further clinical development of MOR106."
"This study represents the next important step in our strategy to progress MOR106 rapidly in the clinic and is expected to provide additional insights into patient response, while we await the results of our ongoing IGUANA Phase 2 trial with MOR106 in atopic dermatitis patients," said Dr. Walid Abi-Saab, Chief Medical 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 have not yet been established. Novartis Pharma AG owns the worldwide, exclusive license for the development and commercialization of MOR106 under an agreement with MorphoSys and Galapagos which became effective on September 10, 2018.