After Futility Analysis, MorphoSys, Galapagos and Novartis Halt Dermatitis Program
MorphoSys, with Mechelen, Belgium-based Galapagos, and Basel, Switzerland-based Novartis made a joint decision to end the clinical development program of MOR106 based on an interim analysis for futility for the Phase II IGUANA clinical trial. The interim analysis found a low likelihood of meeting the primary endpoint of the trial, which was percent change in the eczema area and severity index (EASI) score.
The companies indicate that the decision was based on lack of efficacy, not any safety concerns.
The MOR106 atopic dermatitis clinical development program included two Phase II trials, IGUANA and GECKO, in addition to a Phase I bridging study for subcutaneous formulation. There was also a Japanese ethno-bridging study. All trials were shuttered. The companies expect to discuss what to do with MOR106 moving forward.
The drug was jointly discovered by Galapagos and MorphoSys. They entered into an exclusive global development and commercialization pact with Novartis in July 2018. It was created using MorphoSys’s Ylanthia antibody platform. It was developed based on a target discovered by Galapagos. MOR106 is a human monoclonal antibody directed against IL-17C, which is a cytokine expressed in the skin and has been associated with dermal inflammation.
Novartis Pharma AG owns the worldwide, exclusive license to develop and commercialize MOR106 under a deal with MorphoSys and Galapagos that activated on September 10, 2018.
“We are obviously disappointed with the result of MOR106 in atopic dermatitis,” said Piet Wigerinck, Galapagos’ chief scientific officer. “Together with our collaboration partners, we will explore the future strategy with MOR106.”
According to Reuters, MorphoSys is using funds raised from a second listing in the U.S. in 2018 to develop a U.S. sales force in preparation of the launch of its most advanced compound, MOR208 for relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). MOR208 (tafasitamab) is a monoclonal antibody directed against the antigen CD19, which is expressed on the surface of B-cells. The company expects to complete its BLA to the U.S. Food and Drug Administration (FDA) by year-end and submit to the European Medicines Agency (EMA) by mid-2020.
Of the MOR106 program, Markus Enzelberger, chief scientific officer of MorphoSys stated, “Unfortunately, the results from the interim analysis for futility do not support the continuation of the current clinical development of MOR106 in atopic dermatitis. While we are clearly disappointed, we remain committed to the development of MorphoSys’ proprietary early and late-stage drug candidates, such as MOR202 and especially tafasitamab.”
MOR202 is another human monoclonal antibody, this one directed against CD38 on the surface of multiple myeloma cells. On October 14, MorphoSys announced that the company and I-Mab Biopharma received Investigational New Drug (IND) clearances from the National Medical Products Administration (NMPA) of China to expand the ongoing Phase II and III clinical trials of MOR202 for multiple myeloma to mainland China. I-Mab is a China-based clinical stage biopharma company focused on immuno-oncology and autoimmune diseases. I-Mab owns exclusive rights to develop and commercialize MOR202/TJ202 in China, Taiwan, Hong Kong and Macao.