Novartis cut an atopic dermatitis drug from the team—and it did it on the down low. Buried in its second-quarter financial report is a line revealing that the Swiss pharma is taking a $485 million impairment charge (PDF) for halting clinical development on an eczema program it picked up in its 2016 Ziarco buyout.
The drug, known as ZPL389 or adriforant, is a once-daily oral H4 receptor antagonist and was the center of the deal. Though the duo kept numbers under wraps, anonymous sources told Bloomberg in 2016 that a buyout could be worth upward of $1 billion when milestones and royalties were taken into account.
At the time, the drug had missed an itch-related endpoint in a phase 2a study involving 98 patients with moderate to severe atopic dermatitis, but it did beat placebo at reducing eczema symptoms such as inflammation, as measured by the Eczema Area and Severity Index. Ziarco was preparing to move the ZPL389 into phase 2b, with plans to enroll 300 patients and test three doses.
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When Novartis decided to ditch the drug, it was still in phase 2, with a planned regulatory submission in 2024, according to the second-quarter report. The news comes nine months after MorphoSys and Galapagos canned MOR106, an atopic dermatitis drug on which Novartis bet $110 million (€95 million) in 2018.
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The deal positioned Novartis to take the anti-IL-17C antibody forward in eczema and other indications, with a promise of up to €850 million in milestones. But in October, the partners called it quits because a futility analysis deemed the drug, once seen as a potential challenger to Sanofi and Regeneron’s Dupixent, likely to fail.
Meanwhile, Pfizer is pushing its own Dupixent rival. The JAK inhibitor, abrocitinib, has shown in multiple studies that it can clear patients’ skin and resolve eczema symptoms such as skin inflammation and itching, even logging a slight edge over Dupixent on an itch-related measure in one of the trials. That said, the drug has its own hurdles. It comes with side effects that could "give prescribers pause" and hamper its uptake, in the words of Jefferies analyst Biren Amin.