Incyte Halts Urticaria Drug Trial After Toxicology Findings, Scraps Liver Disease Program
Key Insights
Incyte paused enrollment for INCB000262, a drug being tested for chronic urticaria (search), due to concerning toxicology results from an animal study.
The company discontinued development of INCB000547 after Phase 2 results showed it was ineffective for treating itching associated with liver disease.
These setbacks impact Incyte's strategy to diversify beyond its top-selling drug, Jakafi, and could affect a potential $1.8 billion revenue opportunity.
Incyte has encountered significant setbacks in its efforts to expand its drug portfolio, pausing a Phase 2 trial for INCB000262, an urticaria (search) treatment, and discontinuing the development of INCB000547 for liver disease-related itching. The decision to halt the urticaria trial follows concerning results from a toxicology study in animals, the details of which have not been disclosed. Incyte is collaborating with the FDA to determine the next steps for the program.
Urticaria Drug Development Paused
INCB000262, acquired as part of Incyte's $750 million acquisition of Escient Pharmaceuticals, is an oral treatment targeting MRGPRX2 (search), a protein expressed on mast cells believed to drive urticaria (search). The drug was seen as a potentially transformative treatment for chronic hives, a common condition attracting interest from several drugmakers. RBC Capital Markets analyst Brian Abrahams noted the uncertainty surrounding the future of INCB000262, estimating that the study pause puts a significant $1.8 billion revenue opportunity at risk.
Incyte has completed enrollment in other proof-of-concept studies of INCB000262 in atopic dermatitis (search) and inducible urticaria (search). Data from those trials will guide future development of the drug as well as “back-up molecules,” the company said. Should development continue, results from all three proof-of-concept studies could come in early 2025. If not, Incyte won’t disclose data, though backup drugs could enter human testing “relatively shortly” thereafter, he wrote.
Liver Disease Program Abandoned
Incyte also announced the discontinuation of INCB000547, a drug being developed for itching associated with liver disease, after Phase 2 results failed to support further development. The company did not elaborate on the specific reasons for this decision.
Broader Implications for Incyte
These setbacks highlight the challenges Incyte faces in reducing its reliance on Jakafi, which accounts for nearly 80% of the company's revenue. Jakafi faces increasing competition and potential patent expiration later this decade. Incyte has been actively pursuing diversification through in-house research, partnerships, and acquisitions, including the acquisition of Villaris and Escient Pharmaceuticals. Investors are now closely watching the Phase 3 readout for povorcitinib in hidradenitis suppurativa (search), expected next year, as a critical indicator of Incyte's pipeline strength. Incyte shares fell more than 10% in early trading Tuesday.