- Patients treated with povorcitinib
experienced improvements in total body and facial repigmentation;
investigational therapy was well tolerated
- Results were featured as an oral presentation
in a late-breaking abstract session at the 2023 American Academy of
Dermatology (AAD) Annual Meeting
Incyte (Nasdaq:INCY) today announced new data from a Phase 2b
clinical trial evaluating the safety and efficacy of povorcitinib
(INCB54707), an investigational oral JAK1 inhibitor, in adult
patients with extensive nonsegmental vitiligo. These data were
presented today in a late-breaking oral presentation (Session: S042
– Late-Breaking Research: Session 2) at the 2023 American Academy
of Dermatology (AAD) Annual Meeting, held from March 17-21 in New
Orleans.
Results from the study demonstrate that treatment with oral
povorcitinib was associated with substantial total body
repigmentation in patients with extensive nonsegmental vitiligo, as
measured by total Vitiligo Area Scoring Index (T-VASI) scores.
Specifically, the study met its primary endpoint and patients
receiving povorcitinib experienced statistically superior
improvements in T-VASI at Week 24 compared to placebo (povorcitinib
15 mg, –19.1%; 45 mg, –17.8%; 75 mg, –15.7% vs. placebo, +2.3%;
least squares mean [LSM] difference, P<0.01). Additionally, more
patients who received povorcitinib achieved the key secondary
endpoint of T-VASI50 (≥50% reduction from baseline in the T-VASI)
at Week 24 (10.5%, 15 mg arm; 15.2%, 45 mg arm; 5.6%, 75 mg arm vs.
3.0%, placebo arm) and continued to improve during an open-label
extension period through Week 36 of treatment (28.6%, povorcitinib
15 → 75 mg arm; 17.2%, 45 mg arm; 15.2%, 75 mg arm; and 3.0%,
placebo → 75 mg arm), following dose adjustment.
“Vitiligo is a chronic, immune-mediated disease which, until
recently, had limited treatment options available to patients. We
are proud to have brought to market the first and only U.S. Food
and Drug Administration (FDA) approved pharmacologic therapy for
vitiligo, and continue to develop additional treatments for
patients with vitiligo,” said Kurt Brown, M.D., Global Program
Head, Povorcitinib, and Associate Vice President, Drug Development,
Inflammation & Autoimmunity, Incyte. “These data suggest the
potential of povorcitinib as an oral treatment for patients with
extensive nonsegmental vitiligo and its potential versatility
across multiple autoimmune and inflammatory conditions, including
hidradenitis suppurativa for which we recently announced 52-week
Phase 2 results.”
Additional key findings from the study include:
- Treatment with povorcitinib also resulted in facial
repigmentation in patients with extensive nonsegmental vitiligo, as
measured by facial Vitiligo Area Scoring Index (F-VASI) scores. At
Week 24, patients receiving povorcitinib experienced statistically
superior improvements in F-VASI compared to placebo (15 mg, –27.7%;
45 mg, –36.4%; 75 mg, –29.4% vs. placebo, –5.1%; LSM difference,
P<0.01).
- At Week 24, 18.4% (15 mg), 45.5% (45 mg) and 27.8% (75 mg) of
patients treated with povorcitinib achieved ≥50% reduction from
baseline in F-VASI (F-VASI50) compared to 9.1% in the placebo
group.
- Additionally at Week 24, 13.2% (15 mg), 18.2% (45 mg) and 13.9%
(75 mg) of patients treated with povorcitinib achieved ≥75%
reduction from baseline in F-VASI (F-VASI75) compared to 3.0% in
the placebo group.
- Continued improvement of total body and facial repigmentation
with povorcitinib was seen through 36 weeks of treatment.
- At Week 36, T-VASI/F-VASI scores were –30.3%/–38.4%
(povorcitinib 15 → 75 mg arm), –28.4%/–51.1% (45 mg arm),
–28.8%/–54.3% (75 mg arm) and –5.3%/–26.1% (placebo → 75 mg
arm).
Povorcitinib was generally well tolerated. The most common
treatment-emergent adverse events (TEAEs) during the 24-week
placebo-controlled period (n=126) were COVID-19 (16.7%), headache
(10.3%), fatigue (9.5%), blood creatine phosphokinase increased
(7.9%), and acne (7.1%). No serious TEAEs were considered related
to povorcitinib treatment. Additionally, no new safety signals were
observed after Week 24.
"Vitiligo is a chronic autoimmune condition that can be
difficult to manage, particularly for patients with extensive
disease that manifests across a significant portion of their body,”
said Amit G. Pandya, M.D., Staff Dermatologist, Department of
Dermatology, Palo Alto Foundation Medical Group and Adjunct
Professor, Department of Dermatology, University of Texas
Southwestern Medical Center. “As vitiligo can impact patients in
different ways, I am encouraged by the continued focus on expanding
medical treatment options, and I believe these data highlight the
potential of this investigational oral treatment for patients with
extensive nonsegmental vitiligo.”
More information regarding the 2023 AAD Annual Meeting can be
found at https://www.aad.org/member/meetings-education/am23.
About Vitiligo
Vitiligo is a chronic autoimmune disease characterized by
depigmentation of skin that results from the loss of
pigment-producing cells known as melanocytes. Overactivity of the
JAK signaling pathway is believed to drive inflammation involved in
the pathogenesis and progression of vitiligo. In the United States,
more than 1.5 million people are diagnosed with vitiligo1. The
overall prevalence of the condition is estimated to be
approximately 2-3 million2, with the majority of patients
(approximately 85%) suffering from nonsegmental vitiligo3. Vitiligo
can occur at any age, although many patients with vitiligo will
experience initial onset before the age of 304.
About the Phase 2b Study (NCT04818346)
The Phase 2b randomized, double-blind, placebo-controlled, dose
ranging study is evaluating the efficacy and safety of povorcitinib
(formerly INCB54707) in adult patients with extensive nonsegmental
vitiligo.
The study enrolled 171 patients (age 18 to 75 years) diagnosed
with nonsegmental vitiligo affecting ≥8% of their body surface area
and randomized them 1:1:1:1 to receive once-daily (QD) povorcitinib
15 mg (n=43), 45 mg (n=41), 75 mg (n=42), or placebo (n=42) for 24
weeks during the placebo-controlled period. Of the 171 randomized
patients, 168 patients were treated as part of the 24-week
placebo-controlled period. During the 28-week extension period
(n=138), patients originally randomized to receive povorcitinib 45
mg QD continued with the same dose (n=32). Patients originally
randomized to receive povorcitinib 15 mg QD, 75 mg QD or placebo
each received 75 mg povorcitinib QD for the duration of the 28-week
extension period (n=37, 34 and 35, respectively). Following the
extension period is a 24-week follow-up period.
The primary endpoint is the percentage change from baseline in
total body Vitiligo Area Scoring Index (T-VASI) at Week 24. The key
secondary endpoint is the percentage of patients achieving T-VASI50
(≥50% reduction from baseline in the T-VASI) at Week 24.
Additional endpoints include the percentage of patients
achieving F-VASI50 (≥50% reduction from baseline in facial Vitiligo
Area Scoring Index [F-VASI]), F-VASI75 (≥75% reduction from
baseline in F-VASI) and T-VASI50 at each visit. Safety of
povorcitinib was assessed by the frequency and severity of
treatment-emergent adverse events (TEAEs).
For more information about this Phase 2b study, please visit:
https://clinicaltrials.gov/ct2/show/NCT04818346.
About Povorcitinib (INCB54707)
Povorcitinib (INCB54707) is an oral small-molecule JAK1
inhibitor currently in Phase 2 clinical trials for vitiligo,
hidradenitis suppurativa (HS) and prurigo nodularis. Phase 3
studies in HS are also ongoing.
About Incyte Dermatology
Incyte’s science-first approach and expertise in immunology has
formed the foundation of the company. Today, we are building on
this legacy as we discover and develop innovative dermatology
treatments to bring solutions to patients in need.
Our research and development efforts in dermatology are
initially focused on leveraging our knowledge of the JAK-STAT
pathway. We are exploring the potential of JAK inhibition for a
number of immune-mediated dermatologic conditions with a high unmet
medical need, including atopic dermatitis, vitiligo, lichen planus,
lichen sclerosus and prurigo nodularis.
To learn more, visit the Dermatology section of Incyte.com.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding the presentation of data from Incyte’s clinical
development pipeline, whether or when povorcitinib will be approved
or commercially available for use in humans anywhere in the world
and Incyte’s goal of improving the lives of patients, contain
predictions, estimates and other forward-looking statements.
These forward-looking statements are based on Incyte’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to: unanticipated delays; further
research and development and the results of clinical trials
possibly being unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; the ability
to enroll sufficient numbers of subjects in clinical trials; the
effects of the COVID-19 pandemic and measures to address the
pandemic on Incyte and its partners’ clinical trials, supply chain,
other third-party providers and development and discovery
operations; determinations made by the U.S. FDA and other
regulatory authorities outside of the United States; the efficacy
or safety of Incyte and its partners’ products; the acceptance of
Incyte and its partners’ products in the marketplace; market
competition; sales, marketing, manufacturing and distribution
requirements; and other risks detailed from time to time in
Incyte’s reports filed with the Securities and Exchange Commission,
including its annual report for the year ended December 31, 2022.
Incyte disclaims any intent or obligation to update these
forward-looking statements.
_______________________ 1 Bergqvist C, Ezzedine K. Vitiligo: A
Review. Dermatology. 2020;236:571-592. 2 Gandhi K, et al.
Prevalence of vitiligo among adults in the United States. JAMA
Dermatol. 2022;158(1):43-50. 3 Ezzedine K, et al. Seminar:
Vitiligo. Lancet. 2015;386:74–84. 4 Frisoli M, et al. Vitiligo:
mechanisms of pathogenesis and treatment. Annu. Rev. Immunol.
2020;38(1):621-648.
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Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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