Incyte’s decision to scrap work on its BET inhibitor program has not surprised analysts, who pointed to safety concerns overshadowing the drug class.
The biopharma, which markets Novartis-partnered blockbuster myelofibrosis drug Jakafi in the U.S., revealed this morning that it has paused development of INCB57643, a BET inhibitor Incyte had been evaluating in a phase 2 myelofibrosis study in combination with Jakafi.
William Blair analysts noted this morning that the BET inhibitor had been due to enter a phase 3 study for myelofibrosis this year but added that they were “not surprised by the program’s discontinuation due to safety concerns for the class.”
Novartis was stung by these concerns last year when it detected an imbalance in the rate of acute myeloid leukemia in a phase 3 study of myelofibrosis drug pelabresib, which it acquired as part of its buyout of MorphoSys. It led the Swiss pharma to delay its approval plans for the BET inhibitor, resulting in an $800 million impairment in the pharma’s finances.
Earlier this year, the FDA slapped a clinical hold on a phase 1b plaque psoriasis study of Vyne Therapeutics’ BET inhibitor after testicular toxicity was reported in dogs from a separate, nonclinical test.
Incyte didn’t allude to any safety concerns in relation to its decision to drop INCB57643, instead attributing the move to its “ongoing pipeline prioritization efforts.” The company is also halting work on an anti-CD122 drug dubbed INCA034460, it said in its third-quarter earnings document. Incyte had been assessing the asset in a phase 1 study for vitiligo.
Those same prioritization efforts mean the biopharma will also stop developing povorcitinib in chronic spontaneous urticaria (CSU), according to the release. Despite narrowing the focus for the JAK1 inhibitor, Incyte is still planning to submit the drug to European regulators for approval as a treatment for moderate to severe hidradenitis suppurativa (HS) before the end of the year, with an application to the FDA to follow in early 2026.
The company arrived at the European Association of Dermatology and Venereology conference last month armed with longer-term HS data showing nearly 60% of patients who received povorcitinib achieved a 50% reduction in inflammatory lesions at Week 24.
While Incyte is no longer considering povorcitinib as a CSU treatment, the company is expecting a phase 3 readout in prurigo nodularis—as well as data from a phase 2 trial in asthma—to arrive next year.
Anchored by blockbuster Jakafi, Incyte’s array of approved meds include fast-growing JAK cream Opzelura, lymphoma med Monjuvi and PD-1 inhibitor Zynyz, among others.