Incyte hits endpoint in 2nd pivotal atopic dermatitis trial

Incyte CEO Hervé Hoppenot
Incyte CEO Hervé Hoppenot (Business Wire)

A second phase 3 trial of Incyte’s ruxolitinib cream in atopic dermatitis has met its primary endpoint. The back-to-back pivotal successes tee Incyte up to talk to regulators about bringing the JAK inhibitor to market.

Ruxolitinib is the small molecule JAK1/2 inhibitor found in Jakafi, Incyte’s myelofibrosis treatment. By reformulating ruxolitinib as a topical cream, Incyte has positioned itself to generate more cash from the molecule by establishing it as a treatment option for patients with atopic dermatitis. That effort took a step forward late last month when Incyte revealed its first phase 3 trial hit its primary goal.

Now, Incyte has reported top-line data from the second phase 3 trial. The second trial also met its primary endpoint, with more than 50% of patients on the higher dose of ruxolitinib achieving success on an investigator assessment compared to 8% in the placebo group.

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The second trial also met a key secondary endpoint. More than 60% of patients taking the ruxolitinib cream achieved a 75% or greater improvement on a measure of atopic dermatitis severity. Around 14% of patients in the control group experienced a comparable improvement.

Those results are in line with findings shared to date from the first clinical trial. With patients in the control arms experiencing more treatment-emergent adverse events than their peers on either dose of ruxolitinib, Incyte thinks it has the data to support talks with regulators about approval.

If Incyte gets to market, it will join a growing number of companies pushing atopic dermatitis drugs. Regeneron and Sanofi beat their would-be rivals to market with Dupixent and quickly began racking up blockbuster sales. However, Dupixent is aimed at a slightly different population than ruxolitinib, as shown by the lower body surface area (BSA) of atopic dermatitis Incyte used in its inclusion criteria.

With Incyte enrolling patients with BSA as low as 3%, compared to upward of 10% in Dupixent trials, it studied ruxolitinib in patients with less severe forms of the disease. As a topical cream, rather than an injectable biologic, ruxolitinib may be preferable to Dupixent for patients with milder conditions. 

However, Incyte will still face competition even if it targets patients with less severe forms of the disease. Pfizer’s Eucrisa, which had a 5% minimum BSA in its pivotal trial inclusion criteria, is a topical ointment that won FDA approval in mild to moderate atopic dermatitis in 2016, although the drug has so far failed to live up to commercial expectations.

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