MorphoSys and Galapagos said they are halting development of MOR106—an atopic dermatitis candidate the companies licensed to Novartis last year for potentially more than $1 billion—after an interim futility analysis of the Phase II IGUANA trial (NCT03568071) showed the drug was unlikely to meet the study’s primary endpoint.
“We are obviously disappointed with this result with MOR106 in atopic dermatitis,” Galapagos CSO Piet Wigerinck, PhD, said in a statement. “Together with our collaboration partners, we will explore the future strategy with MOR106.”
Launched in May 2018, IGUANA was designed to assess the efficacy, safety, tolerability, and pharmacokinetic/pharmacodynamics (PK/PD) of MOR106 in atopic dermatitis. The trial’s primary endpoint was defined as the percentage change in the eczema area and severity index (EASI) score.
IGUANA was one of two Phase II trials within the clinical development program for MOR106 in atopic dermatitis. The candidate was also being assessed in the Phase II GECKO trial (NCT03864627), designed to investigate the safety and tolerability of repeated subcutaneous doses of MOR106 administered concomitantly with topical corticosteroids in subjects with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy. GECKO was launched in April.
The clinical program for MOR106 also included a Phase I bridging study assessing a subcutaneous formulation of the drug (NCT03689829); and a Japanese ethno-bridging study.
All studies in atopic dermatitis will end, with MorphoSys, Galapagos, and Novartis to assess a future strategy for MOR106, a fully human, IgG1 monoclonal antibody designed to target interleukin 17C (IL-17C).
“We see great potential for MOR106, which is, to the best of our knowledge, the first program against IL-17C in clinical development,” MorphoSys’ then-CEO Simon Moroney, PhD, told analysts May 8 on the company’s quarterly conference call following the release of first-quarter 2019 results. Moroney has since retired and has been succeeded by Jean-Paul Kress, MD, effective September 1.
According to the companies, MOR106 is the first publicly known human monoclonal antibody in worldwide clinical development that is directed against IL-17C, 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.
“Unfortunately, the results from the interim analysis for futility do not support the continuation of the current clinical development of MOR106 in atopic dermatitis,” added MorphoSys CSO Markus Enzelberger, PhD. “While we are clearly disappointed, we remain committed to the development of MorphoSys’ proprietary early and late-stage drug candidates.”
Those candidates, Enzelberger said, include MOR202, a human monoclonal HuCAL antibody directed against CD38 in clinical development for the treatment of multiple myeloma (MM) and potentially autoimmune diseases; and “especially” tafasitamab (MOR208/TJ302), a humanized monoclonal antibody directed against CD19 in clinical development for the treatment of B cell malignancies. MorphoSys is partnering with I-Mab Biopharma to develop tafasitamab for multiple myeloma in the Greater Chinese market (China, Hong Kong, Taiwan, Macao).
Galapagos and MorphoSys jointly discovered MOR106 using MorphoSys’ Ylanthia antibody platform, based on a target discovered by Galapagos.
In July 2018, Galapagos and MorphoSys signed an exclusive worldwide development and commercialization collaboration through which they licensed the drug to Novartis for up to $1 billion-plus.
Novartis agreed to pay MorphoSys and Galapagos €95 million ($105 million) upfront; up to approximately €850 million ($943 million) in payments tied to achieving developmental, regulatory, commercial, and sales-based milestones; plus royalties of up to low-teens to low-twenties. Novartis also agreed to bear all research, development, manufacturing and commercialization costs.
Novartis agreed to explore the potential of MOR106 in additional indications beyond atopic dermatitis, Moroney told analysts in May.