Incyte Treats First Patient in Phase III Vitiligo Study

Incyte INCY announced that the first patient has been treated in the TRuE-V clinical program evaluating the cream formulation of ruxolitinib as monotherapy for vitiligo.

The TRuE-V clinical program includes two phase III studies — TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573) — evaluating the safety and efficacy of ruxolitinib cream in patients with vitiligo, a chronic autoimmune disease.

Both studies will enroll approximately 300 patients (age either 12 years or above) who have been diagnosed with non-segmental vitiligo and have depigmented areas including at least 0.5% of the body surface area (BSA) on the face with a facial vitiligo area severity index [F-VASI] score of equal or greater than 0.5.  The patients who will be enrolled should also have at least 3% BSA on non-facial areas, a total body Vitiligo Area Scoring Index score of equal to or greater than 3 and total BSA involvement (facial and nonfacial) of up to 10%.

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

The cream formulation is currently in phase III development for the treatment of patients with mild to moderate atopic dermatitis (TRuE-AD), with initial results expected in the first half of 2020. It is also being evaluated for the treatment of adolescents and adults with vitiligo (TRuE-V).

There are currently no approved treatments in the United States and Europe for the treatment of vitiligo and potential label expansion will drive the top line.

Shares of the company have gained 18.1% in the year so far against the industry’s 3.8% decline.

Jakafi is Incyte’s lead drug. The company has a collaboration agreement with Novartis NVS for the same. It has a second JAK1 and JAK2 inhibitor, baricitinib, in collaboration with Eli Lilly LLY. Per the terms, Lilly owns exclusive worldwide development and commercialization rights to the compound for inflammatory and autoimmune diseases.

The company’s efforts to diversify its revenue base are impressive, but pipeline setbacks are a concern.

Zacks Rank & Stock to Consider

Incyte currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the biotech sector is Amgen, Inc. AMGN, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Earnings estimates for Amgen have increased 40 cents for 2019 in the past sixty days.

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