Incyte details late-stage data on ruxolitinib cream for atopic dermatitis

Following up on its initial announcements in January and February, Incyte (NASDAQ:INCY) reports detailed results from two successful Phase 3 clinical trials, TRuE-AD1 and TRuE-AD2, evaluating a topical cream formulation of kinase inhibitor ruxolitinib in adolescents and adults with atopic dermatitis (AD). The data were presented at the Revolutionizing Atopic Dermatitis Virtual Symposium.

Both studies met the primary endpoint of a statistically significant proportion of treated patients achieving clear or almost clear skin at week 8 compared to vehicle cream (placebo). Specifically, 50.0% of patients in AD1 and 39.0% in AD2 who received twice daily applications of 0.75% ruxolitinib cream achieved clear/almost clear skin compared to 15.1% and 7.6%, respectively, in the vehicle arms. 53.8% and 51.3%, respectively, of patients receiving 1.5% ruxolitinib cream achieved clear/almost clear skin.

Treated patients also experienced statistically significant reductions in itching as measured by a scale called NRS score.

No new safety signals were observed.

The company markets an oral formulation of ruxolitinib under the brand name Jakafi.

The standard-of-care topical treatment of AD is corticosteroid creams, lotions or ointments.

The FDA approved Pfizer’s (NYSE:PFE) non-steroidal Eucrisa (crisaborole) ointment, which inhibits a pro-inflammatory enzyme called phosphodiesterase 4 (PDE4), in December 2016. In two pivotal studies, 32.8% and 31.4%, respectively, of treated patients achieved clear/almost clear skin at day 29.

The company plans to file a marketing application in the U.S. in Q4.

Management will host a conference call on Monday, April 6, at 8:00 am ET to discuss the data.

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https://seekingalpha.com/news/3558456-incyte-details-late-stage-data-on-ruxolitinib-cream-for-atopic-dermatitis