MorphoSys and Galapagos have commenced a Phase II clinical trial, in alliance with Novartis Pharma, to assess subcutaneous MOR106 in combination with topical corticosteroids to treat moderate to severe atopic dermatitis.
MOR106 is a human monoclonal antibody that targets the IL-17C cytokine, which is preferentially expressed in the skin and linked to dermal inflammation.
As part of an agreement with MorphoSys and Galapagos, Novartis Pharma holds the exclusive licence to develop and commercialise MOR106 globally.
MorphoSys chief development officer Malte Peters said: “Moderate to severe atopic dermatitis is a chronic, debilitating disease affecting millions of patients worldwide. We see a clear unmet medical need for additional treatment options.
“We look forward to further expanding the development programme of MOR106 for these patients with the IND opening Phase II trial we have now initiated together with our partner Galapagos under the global licensing agreement with Novartis.”
Dubbed GECKO, the Phase II trial will evaluate the safety and tolerability of MOR106 plus topical steroids, compared to placebo, over eight weeks in a total of 60 patients.
The trial, which comprises a 16-week follow-up period, will track the incidence of treatment-emergent adverse and serious adverse events to day 169 as its primary endpoint.
Secondary endpoints of the study include pharmacokinetics (PK) and the occurrence of anti-drug antibodies following subcutaneous administration.
The trial will also assess the investigational drug’s efficacy. Patients will be enrolled at clinical sites across the US and Canada.
Galapagos chief scientific officer Piet Wigerinck said: “This IND opening study extends the development programme for MOR106 to the US and Canada, which complements the ongoing clinical evaluations in Europe.”