Clinical Trials

Date: 2018-09-13

Type of information: Initiation of the trial

phase: 1

Announcement: initiation of the trial

Company: Galapagos (Belgium) Morphosys (Germany)

Product: MOR106

Action mechanism:

• monoclonal antibody. MOR106 is a human monoclonal antibody designed to selectively target IL-17C. IL-17C has been shown to be distinct from other members of the IL-17 cytokine family and to play an important and pro-inflammatory role in certain skin disorders.
• MOR106 was generated using MorphoSys's Ylanthia antibody platform and is based on a target discovered by Galapagos.. 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.

Disease: atopic dermatitis

Therapeutic area: Autoimmune diseases - Dermatological diseases

Country:

Trial details:

Latest news:

• • On September 13, 2018, Galapagos and MorphoSys announced 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.

     

Is general: Yes