- Longer-term use of povorcitinib resulted in
further improvement in total body and facial repigmentation
- Results were presented in a late-breaking
news session at the European Academy of Dermatology and Venereology
(EADV) Congress 2023
Incyte (Nasdaq:INCY) today announced new 52-week 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. Results
showed that treatment with oral povorcitinib was associated with
substantial total body and facial repigmentation across all
treatment groups at Week 52. These data were presented today in a
late-breaking oral presentation (Abstract #6749 Session: D1T01.1A –
Late-Breaking News) at the European Academy of Dermatology and
Venereology (EADV) Congress 2023, held from October 11-14 in
Berlin.
Specifically, these results, which build on the previously
announced data, showed:
- Mean percentage total body depigmentation improvement from
baseline as measured by the Total Vitiligo Area Scoring Index
(T-VASI) at Week 52 for povorcitinib 15-to-75 mg, 45 mg, 75 mg and
placebo-to-75 mg were 40.7%, 42.7%, 41.3% and 18.1%,
respectively.
- Mean percentage facial depigmentation improvement from baseline
as measured by the facial Vitiligo Area Scoring Index (F-VASI) at
Week 52 for povorcitinib 15-to-75 mg, 45 mg, 75 mg and
placebo-to-75 mg were 63.6%, 63.8%, 64.4% and 54.8%,
respectively.
“These 52-week results further support earlier data and
reinforce the efficacy profile and potential of povorcitinib as an
oral treatment for patients with extensive nonsegmental vitiligo,”
said Kurt Brown, M.D., Vice President and Povorcitinib Global
Program Head, Incyte. “At Incyte, we are deeply committed to
addressing unmet needs in the vitiligo community and understanding
how this disease can affect patients’ lives. Today’s data highlight
exciting progress as we work to bring new potential treatment
options to patients living with this immune-mediated skin
condition.”
Key secondary endpoint findings include:
- More on-treatment patients achieved ≥50% reduction from
baseline in T-VASI (T-VASI50) at Week 52 compared to initial
findings at Week 24 (povorcitinib 15-to-75 mg arm, 45.2%; 45 mg
arm, 37.0%; 75 mg arm, 37.9%; placebo-to-75 mg arm, 15.2%).
- More on-treatment patients achieved ≥50% and >75% reduction from baseline in F-VASI
(F-VASI50 and F-VASI75, respectively) at Week 52 compared to
initial findings at Week 24 (povorcitinib 15-to-75 mg arm, 71.0%
and 48.4%; 45 mg arm, 77.8% and 55.6%; 75 mg arm, 69.0% and 58.6%;
placebo-to-75 mg arm, 63.6% and 45.5%, respectively).
- Povorcitinib was well tolerated at all doses.
Treatment-emergent adverse events (TEAEs) of any grade occurred in
89.2% of 83 patients who received 45 mg or 75 mg doses throughout
the study period; the most common were COVID-19 (36.1%), blood
creatine phosphokinase increased (13.3%), acne (12.0%), fatigue
(10.8%) and headache (9.6%).
- Among the 32 patients who completed the follow-up period
through Week 76, total body and facial repigmentation was
maintained, which suggests durability of response following
treatment discontinuation. Sample size during post-treatment was
small, limiting interpretation, and findings need to be confirmed
in a larger population.
“Vitiligo often has a significant impact on patients’ lives, and
there is a need for new treatment options that can offer solutions
to people with extensive disease who desire repigmentation,” said
Khaled Ezzedine, M.D., Ph.D., Professor, Department of Dermatology,
Henri Mondor Hospital and EpiDermE, Université Paris. “Today’s
results provide an encouraging update in support of a potential
oral option to treat extensive nonsegmental vitiligo. It is
exciting to see continued progress in this space that, until
recently, had limited options for patients.”
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.
More information regarding the EADV Congress 2023 can be found
at https://eadvcongress2023.org/.
About the Phase 2b Study (NCT04818346)
The Phase 2b randomized, double-blind, placebo-controlled, dose
ranging study evaluated 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 was a 24-week follow-up period.
The primary endpoint was the percentage change from baseline in
total body Vitiligo Area Scoring Index (T-VASI) at Week 24. The key
secondary endpoint was the percentage of patients achieving ≥50%
reduction from baseline in the T-VASI (T-VASI50) at Week 24.
Additional endpoints included the percentage of patients
achieving ≥50% reduction from baseline in facial Vitiligo Area
Scoring Index (F-VASI; F-VASI50), ≥75% reduction from baseline in
F-VASI (F-VASI75) 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/study/NCT04818346.
About Povorcitinib (INCB54707)
Povorcitinib (INCB54707) is an oral small-molecule JAK1
inhibitor currently in Phase 2 clinical trials for vitiligo,
hidradenitis suppurativa (HS), prurigo nodularis, chronic
spontaneous urticaria and asthma. 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, hidradenitis
suppurativa, 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, if so, whether it will provide a successful treatment option
for patients with vitiligo, and Incyte’s dermatology program
generally 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;
determinations made by the FDA, EMA and other regulatory
authorities; the efficacy or safety of Incyte’s products; the
acceptance of Incyte’s 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 and its quarterly report on Form 10-Q
for the quarter ended June 30, 2023. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231010468675/en/
Media media@incyte.com
Investors ir@incyte.com
Incyte (NASDAQ:INCY)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Incyte (NASDAQ:INCY)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024