Incyte Announces Positive Results from a Phase 2 Study of Ruxolitinib Cream in Patients with Vitiligo
- 24-week results demonstrate significant improvement in repigmentation of facial vitiligo lesions after treatment with ruxolitinib cream
- Data presented at the
World Congress of Dermatologysupport the planned initiation of a pivotal Phase 3 program, for which preparations are currently underway
- Investor conference call and webcast scheduled for
Monday, June 17at 8 a.m. EDT
These results are being presented at the 24th
“The positive 24-week data presented at the
Key 24-week results include:
- Significantly more patients achieved F-VASI50 after 24 weeks of treatment with all ruxolitinib cream regimens compared to the vehicle control. The highest F-VASI50 response was achieved with ruxolitinib cream 1.5 percent QD and BID compared to vehicle control (50 percent and 45 percent vs. 3 percent, respectively; P<0.001).
- A ≥75 percent improvement from baseline in the facial vitiligo area severity index score was achieved by 17 percent, 30 percent, and 0 patients treated with ruxolitinib cream 1.5 percent QD, BID, and vehicle cream, respectively.
- Facial Physician Global Vitiligo Assessment (F-PhGVA) scores of clear (no signs of vitiligo) or almost clear (only specks of depigmentation present) skin were achieved by 13 percent, 9 percent, and 0 patients receiving ruxolitinib cream 1.5 percent QD, BID, and vehicle cream, respectively.
- Ruxolitinib cream was generally well-tolerated at all dosage strengths.
Over-activity of the JAK signaling pathway has been shown to drive inflammation involved in the pathogenesis and progression of vitiligo. These data on ruxolitinib cream, a JAK inhibitor, support the planned initiation of pivotal Phase 3 development later in 2019, for which preparations are already underway.
“As a physician, I am looking for safe and effective options that may
help my patients achieve their treatment goals,” said
Vitiligo is a chronic, immune-mediated skin disease that is estimated to affect between 2 and 3 million people in the U.S. and for which there is no known cure. It can occur at any age, although many people experience vitiligo symptoms before the age of 20.
Vitiligo is characterized by the progressive loss of pigmentation in patches of skin across the body, causing the skin to appear lighter. This occurs when pigment-producing cells known as melanocytes are destroyed or stop functioning. Vitiligo can affect any area of skin on the body and may also affect hair, eyes or the inside of the mouth. The exact cause of vitiligo is unknown, though recent research suggests that changes in the immune system may be responsible for the disease.
About the Study
The safety and efficacy of ruxolitinib cream were evaluated in an
Patients were equally randomized across five treatment arms, including: ruxolitinib cream 1.5 percent, 0.5 percent or 0.15 percent administered QD; ruxolitinib cream 1.5 percent administered BID; or vehicle control for 24 weeks.
The primary efficacy endpoint was the percentage of patients treated with ruxolitinib cream who achieved F-VASI50 score at Week 24, compared to patients treated with vehicle control. Key secondary endpoints included the proportion of patients who achieved a F-PhGVA score of 0 or 1 at Week 24 and the safety and tolerability of ruxolitinib cream.
For more information about the study, please visit: https://clinicaltrials.gov/ct2/show/NCT03099304
About Ruxolitinib Cream
Ruxolitinib cream is a proprietary formulation of Incyte’s selective
JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical
application. Ruxolitinib cream is currently in Phase 3 development for
the treatment of patients with mild to moderate atopic dermatitis
(TRuE-AD) with results expected in the first half of 2020, and is
expected to enter Phase 3 development for the treatment of certain
patients with vitiligo (TRuE-V) in the second half of 2019.
Conference Call Information
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Forward Looking Statements
Except for the historical information set forth herein, the matters set
forth in this press release, including statements regarding the
Company’s plans to initiate a Phase 3 program for ruxolitinib cream in
vitiligo, the timing and potential results of such a Phase 3 program,
the potential for ruxolitinib cream to be an effective treatment option
for patients with vitiligo and whether or when ruxolitinib cream will be
approved for the treatment of vitiligo, contain predictions, estimates
and other forward-looking statements. These forward-looking statements
are based on the Company’s current expectations and subject to risks and
uncertainties that may cause actual results to differ materially,
including unanticipated developments and the risks related to the
efficacy or safety of the Company’s development pipeline, the results of
further research and development, the high degree of risk and
uncertainty associated with drug development, clinical trials and
regulatory approval processes, other market or economic factors and
competitive and technological advances; and other risks detailed from
time to time in the Company’s reports filed with the
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Michael Booth, DPhil
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