Incyte Gets Phase II Win, Targets Blockbuster Dupixent in Skin Disease
11 Mar 2024
Clinical ResultPhase 3Phase 2Drug Approval
Pictured: Incyte building in Wilmington, Delaware/iStock, Bo Shen
Incyte is on target to potentially challenge Sanofi and Regeneron’s blockbuster injectable Dupixent with its oral JAK1 inhibitor for prurigo nodularis. The biopharma presented positive Phase II results at the American Academy of Dermatology annual meeting Sunday.
Povorcitinib helped a significant number of patients in the study to achieve a four point or greater improvement on the itch Numerical Rating Scale (NRS4). Across the three dosing groups, 36% to 54% of patients had itch improvement compared to the 8% on placebo at week 16 of the study. Those in the highest dosage group of 75 mg achieved the NRS4 within a median time of 17 days.
The drug also performed well in its secondary endpoint to achieve Investigator’s Global Assessment Treatment Success scores of 0 or 1 with a greater than 2-grade improvement from baseline. The treatment was considered well-tolerated with few discontinuations due to adverse events. Although cross-trial comparisons are not always accurate, the data suggests povorcitinib could be a comparable treatment for PN to Sanofi and Regeneron’s already-approved Dupixent.
Prurigo nodularis (PN) is a chronic inflammatory disease of the skin characterized by intense itching and thickened bumps on the extremities and trunk. The itchy nodules are often the worst aspect of the condition. Stopping the itch is “imperative” to treat PN patients as the itching multiplies the nodules, Martin Metz, a professor of dermatology, said in a statement.
A Phase III trial is in its planning stages for PN. The candidate is already in a late-stage trial for hidradenitis suppurative and vitiligo. Additional indications in Phase II studies include asthma and chronic spontaneous urticaria.
If the oral JAK inhibitorJAK inhibitor is approved, it’ll enter the market to challenge Sanofi and Regeneron’s blockbuster. Already approved for PN plus four other conditions, Dupixent sales in 2023 reached nearly $11.6 billion. The drug is an injectable, compared to Incyte’s oral formulation for povorcitinib.
In the company’s fourth quarter of 2023 earnings call last month, Incyte CMO Steven Stein said Dupixent’s prior approval provided the regulatory pathway “in terms of itch resolution and skin change resolution.” Stein also touted the once-daily oral convenience of povorcitinib.
Incyte currently has a JAK inhibitorJAK inhibitor cream on the market—Opzelura—for eczema and nonsegmental vitiligo.
Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.
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