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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 Dermatology support the
    planned initiation of a pivotal Phase 3 program, for which
    preparations are currently underway
  • Investor conference call and webcast scheduled for Monday, June 17
    at 8 a.m. EDT

WILMINGTON, Del.–(BUSINESS WIRE)–$INCY #wcd2019–Incyte (Nasdaq:INCY) today announces 24-week results from its
randomized, double-blind, dose-ranging, vehicle-controlled, Phase 2
study evaluating ruxolitinib cream, a nonsteroidal, anti-inflammatory,
JAK inhibitor therapy, in adult patients (18 to 75 years of age) with
vitiligo. The study met its primary endpoint, demonstrating that
significantly more patients treated with ruxolitinib cream for 24 weeks
achieved a ≥50 percent improvement from baseline in the facial vitiligo
area severity index (F-VASI50) score compared to patients treated with a
vehicle control (non-medicated cream). F-VASI50 response was most
notably achieved with ruxolitinib cream 1.5 percent administered once
daily (QD) and twice daily (BID) vs. vehicle control (50 percent and 45
percent vs. 3 percent, respectively; P<0.001).

These results are being presented at the 24th World Congress
of Dermatology (WCD) in Milan, Italy, during a late-breaking research
session today, June 15, 2019, from 9:25 a.m. CET to 9:35 a.m. CET (3:25
a.m. EDT to 3:35 a.m. EDT). (Location: Room Yellow 3).

“The positive 24-week data presented at the World Congress of
Dermatology support the potential of ruxolitinib cream to offer a novel
treatment option for patients with this chronic autoimmune disease,”
said Steven Stein, M.D., Chief Medical Officer, Incyte. “For patients
who choose to seek treatment for their vitiligo, current options are
often limited by inadequate efficacy or potential side effects. We look
forward to advancing ruxolitinib cream into Phase 3 development for
vitiligo in the hope that it may become the first approved treatment for
what can be a life-altering disease.”

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 David Rosmarin,
M.D., Assistant Professor at the Tufts University School of Medicine. “I
am encouraged by these clinical trial results and the potential of
ruxolitinib cream to become an important treatment option for the
repigmentation of vitiligo lesions.”

About Vitiligo

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
Incyte-sponsored randomized, double-blind, dose-ranging,
vehicle-controlled, Phase 2 study (NCT03099304), which began in April
2017. The Phase 2 study program is comprised of three parts spanning 104
weeks. The first part of the study – the findings for which are being
presented at the 24th WCD – spanned 24 weeks and enrolled 157 adults
(aged 18-75 years) diagnosed with vitiligo and with depigmented areas of
at least 0.5 percent of the body surface area (BSA) on the face and at
least 3 percent of the total BSA on nonfacial areas.

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. Incyte has
worldwide rights for the development and commercialization of
ruxolitinib cream.

Conference Call Information

Incyte will host an investor conference call and webcast at 8:00 a.m.
EDT on Monday, June 17, 2019—the call and webcast can be accessed via
the Events and Presentations tab of the Investor section of www.incyte.com.

To access the conference call on Monday, June 17, 2019, please dial
877-407-3042 for domestic callers or +1-201-389-0864 for international
callers. When prompted, provide the conference identification number,
13689599.

If you are unable to participate, a replay of the conference call will
be available for 30 days. The replay dial-in number for the United
States is 877-660-6853 and the dial-in number for international callers
is +1-201-612-7415. To access the replay you will need the conference
identification number, 13689599.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte, please
visit the Company’s website at www.incyte.com.

Follow @Incyte on Twitter at https://twitter.com/Incyte.

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 Securities and
Exchange Commission, including its Form 10-Q for the quarter ending
March 31, 2019. Incyte disclaims any intent or obligation to update
these forward-looking statements.

Contacts

Media
Catalina Loveman
+1 302 498 6171
[email protected]

Investors
Michael Booth, DPhil
+1 302 498 5914
[email protected]

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