Incyte's JAK cream Opzelura proves its worth in treating hidradenitis suppurativa in midstage study

Clinical ResultPhase 3Phase 2Drug Approval
Incyte's JAK cream Opzelura proves its worth in treating hidradenitis suppurativa in midstage study
Source: FiercePharma
Opzelura is a cream version of Incyte's blockbuster Jakafi.
After a pair of approvals in recent years and as its sales continue to climb, Incyte's topical JAK inhibitorJAK inhibitor Opzelura is adding to its clinical case with trial results that demonstrate its benefits in patients with mild to moderate hidradenitis suppurativa (HS).
In a phase 2 study testing twice-daily Opzelura cream in patients with mild to moderate HS, investigators noted a “significantly greater” reduction in patients’ abscesses and inflammatory nodule (AN) count after 16 weeks compared with patients who received a control cream.
The disease is characterized by painful nodules and abscesses that can cause irreversible tissue destruction and scarring.
The results, which the company shared in a presentation at this year’s American Academy of Dermatology meeting, show “great potential” for patients with milder HS, Incyte's vice president of inflammation and autoimmunity, Jim Lee, M.D., Ph.D., said in a release.
“Despite its daily impact on the lives of patients, there are currently no approved therapies for mild-to-moderate HS and the current standard of care is often inadequate,” Lee added. “Today’s data represent an important step in progressing research for HS with the goal of being able to provide patients with an effective option to better manage their condition.”
The drug reduced total AN count by 50% or more in roughly 79% of patients, while more than 20% of patients who received the drug achieved complete clearance.
Plus, the majority of Opzelura patients met the criteria for Hidradenitis Suppurativa Clinical Response, a measure that includes a 50% or greater reduction in AN count without an increase in abscesses or draining fistulas.
Two patients did discontinue their participation in the study, but no serious treatment-emergent adverse events were reported, Incyte said.
Opzelura is a cream version of Incyte’s blockbuster Jakafi and scored its original approval in 2021 for atopic dermatitis, adding on an indication for vitiligo the following year.
The med is currently the only topical JAK inhibitorJAK inhibitor on the U.S. market, but Leo Pharma and its contender delgocitinib stand to put pressure on Incyte’s dominance. Recently, the company has been steadily reporting positive phase 3 studies of its JAK inhibitorJAK inhibitor cream in chronic hand eczema.
Elsewhere in Incyte’s JAK inhibitorJAK inhibitor arsenal is its oral povorcitinib, which just showed significant improvements in itch and disease severity in a phase 2 study in prurigo nodularis.
Opzelura is also being tested in prurigo nodularis and is proving to be a rising star for Incyte. The drug brought in $338 million in 2023 sales as “one of the best recent dermatology launches,” the company's North American general manager Barry Flannelly said on the company’s fourth-quarter and full-year earnings conference call.
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