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Incyte's Phase III Atopic Dermatitis Study Meets Primary Goal

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Incyte Corporation (INCY - Free Report) announced that its pivotal phase III TRuE-AD2 study, which is part of the TRuE-AD clinical program and evaluating the cream formulation of ruxolitinib for atopic dermatitis (AD), met its primary endpoint.

The TRuE-AD2 study evaluated the safety and efficacy of ruxolitinib cream in adolescent and adult patients aged at least 12 years and above with AD.

Significantly, more patients who were treated with ruxolitinib cream 0.75% and 1.5% achieved clear or almost clear skin with at least a two-point improvement from baseline at week 8 of the treatment regime compared to patients treated with vehicle control (non-medicated cream).

Notably, the overall efficacy and safety profile of ruxolitinib cream was similar to the previously released data while no new safety signals were observed.

This positive data from the TRuE-AD2 study will be submitted at an upcoming scientific conference.

The TRuE-AD clinical program includes two phase III studies, namely TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651) evaluating ruxolitinib cream for treating AD. Initial results from the TRuE-AD1 study are expected in the first quarter of 2020. Incyte is focused on developing a new first-line treatment option for the given patient population.

Shares of Incyte have lost 4.4% in the past year compared with the industry’s decline of 5.5%.

Apart from atopic dermatitis, the cream formulation of ruxolitinib is also being evaluated for the treatment of adolescents and adults with vitiligo, a chronic autoimmune disease. In September 2019, Incyte treated the first patient in the TRuE-V clinical program evaluating the cream formulation of ruxolitinib as a monotherapy for vitiligo.

We note that ruxolitinib, an oral JAK1 and JAK2 inhibitor, is marketed as tablets under the brand name Jakafi, Incyte’s lead drug for the treatment of adults with myelofibrosis besides treating adults with polycythemia vera, who have had an inadequate response to or are intolerant of hydroxyurea and both adult and pediatric patients aged 12 years or older suffering steroid-refractory acute graft-versus-host disease (GVHD).

While Incyte markets the drug in the United States, Novartis NVS sells it as Jakavi outside the country. In the first nine months of 2019, Jakafi recorded net sales of $1.2 billion, reflecting 21% growth year over year. A potential label expansion of the medicine will drive the company’s top line.

Zacks Rank & Stocks to Consider

Incyte currently carries a Zacks Rank #4 (Sell).

Better-ranked stocks in the biotech sector include PDL BioPharma, Inc. PDLI and Denali Therapeutics Inc. DNLI, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

PDL BioPharma’s earnings estimates have been revised 37.5% upward for 2020 over the past 60 days. The stock has inched up 0.9% in the past year.

Denali’s loss per share estimates have narrowed 0.4% for 2020 over the past 60 days. The stock has surged 31.4% in the past year.

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