Novartis' $111M bet on IL-17C drug turns sour — but MorphoSys, Galapagos will explore options
Just a year after Novartis bought its way into MorphoSys’ and Galapagos’ development pact for MOR106, the partners are writing off the atopic dermatitis treatment and extinguishing hopes for $1 billion in milestones.
MOR106 did not pass an interim analysis for futility during the Phase II IGUANA trial, the two European biotechs (MorphoSys in Munich and Galapagos in Mechelen, Belgium) disclosed. Novartis was apparently also involved in the decision after it was determined that the study had a low probability of meeting the primary endpoint on the eczema area and severity index, or EASI, score.
“We are obviously disappointed with this result with MOR106 in atopic dermatitis,” Galapagos CSO Piet Wigerinck said in a statement. “Together with our collaboration partners, we will explore the future strategy with MOR106.”
They emphasized that the drug’s fault was entirely in lack of efficacy and not about safety.
Before the atopic dermatitis program was terminated, MOR106 was being tested in two Phase II studies, a Phase I bridging study for a subcutaneous formulation, and a Japanese ethno-bridging study.
Novartis paid $111 million upfront — and committed to footing the R&D, manufacturing and commercialization bills — last July to gain development and marketing rights to the IL-17C inhibitor, which also allowed them to explore additional indications.
Jumping into the atopic dermatitis arena meant facing Big Pharma rivals already fielding their blockbuster contenders, most notably Dupixent from Regeneron and Sanofi. The drug, a monoclonal antibody that targets IL-4 and IL-13, has racked up $920 million in the first half of the year. Pfizer is mounting a challenge with its heavyweight JAK1 inhibitor abrocitinib, posting strong Phase III results (including EASI) against Dupixent and Eli Lilly’s Olumiant just days ago.
The Swiss pharma giant’s hopes will now be on ZPL389, acquired in the Ziarco buyout late 2016. In its latest quarterly update Novartis indicated Phase IIb enrollment has begun, and the first regulatory submissions are planned for 2022.