- Randomized Phase 2 study met its primary and secondary
endpoints following 16 weeks of treatment across all dosing groups,
reinforcing povorcitinib’s potential role in treating prurigo
nodularis (PN)
- Results presented as a late-breaking oral presentation at the
American Academy of Dermatology (AAD) Annual Meeting marks Incyte’s
first presentation of data in PN
Incyte (Nasdaq:INCY) today announced results from a Phase 2
study evaluating the efficacy and safety of povorcitinib
(INCB54707), an oral JAK1 inhibitor, in adult patients with prurigo
nodularis (PN). These data were presented as a late-breaking oral
presentation (Session: S050 – Late-Breaking Research: Session 2) at
the American Academy of Dermatology (AAD) Annual Meeting, held from
March 8-12, 2024, in San Diego.
The study met its primary endpoint with a ≥4-point improvement
in itch Numerical Rating Scale (NRS4) score achieved by
significantly more patients who received povorcitinib across all
dosing groups (36.1% [P<0.01], 44.4% [P<0.001], 54.1%
[P<0.0001] for 15, 45, 75 mg, respectively) than those who
received placebo (8.1%) at Week 16. Median times to itch NRS4 were
58, 35 and 17 days for patients who received 15, 45 and 75 mg of
povorcitinib, respectively, and was not estimable for the placebo
arm.
“PN is a condition that can cause itchy bumps on the skin called
nodules, which appear after excessive scratching. Despite the
severity of the disease and the significant impact it can have on a
patient’s day-to-day life, there remains a significant need for
effective treatments,” said Kurt Brown, M.D., Vice President and
povorcitinib Global Program Head, Incyte. “These Phase 2 results,
particularly the demonstrated improvement in itch resolution after
just four weeks of treatment, are promising for patients around the
world living with this disease. We are excited to be expanding
research on povorcitinib into this new potential indication.”
The secondary endpoints of the study were also met. At Week 16,
13.9%, 30.6% and 48.6% of patients who received 15, 45 and 75 mg of
povorcitinib, respectively, achieved an Investigator’s Global
Assessment Treatment Success (IGA-TS) score of 0 or 1 with a
≥2-grade improvement from baseline, versus 5.4% of patients who
received placebo. Further, 8.3%, 22.2% and 35.1% of patients who
received 15, 45 and 75 mg of povorcitinib, respectively, achieved
both itch NRS4 and IGA-TS at Week 16, versus 2.5% of patients who
received placebo.
Povorcitinib was generally well-tolerated, and the safety
profile was consistent with previously reported data. The most
common treatment-emergent adverse events (TEAEs) among patients who
received povorcitinib were headache (11.1%), fatigue (9.3%) and
nasopharyngitis (7.4%). Grade ≥3 TEAEs and serious TEAEs occurred
in four (3.7%) and nine (8.3%) povorcitinib-treated patients,
respectively, and discontinuations due to AEs were infrequent
(povorcitinib, n=5 [4.6%]; placebo, n=1 [2.7%]).
“PN can often be difficult to treat due to the uncontrollable
itching and scratching, which can multiply the nodules that appear
on a patient’s skin,” said Dr. Martin Metz, Professor of
Dermatology and Allergy, Charité. “Breaking the itch-scratch cycle
is imperative when treating patients with PN, and I’m encouraged by
these results illustrating improvement in itch and also skin
clearance by Week 16 which shows promise for povorcitinib as a
potential novel treatment option for these patients.”
More information regarding the AAD Annual Meeting 2024 can be
found at https://www.aad.org/member/meetings-education/am24.
About Prurigo Nodularis
Prurigo nodularis (PN) is a chronic inflammatory skin disease
characterized by intense itch and thickened red bumps on the arms,
legs and trunk.1 Due to the result of persistent, intense
scratching and rubbing of the skin, PN results in itchy bumps on
the skin called “nodules”.2 PN appears to be more common in older
individuals, and the painful bumps and constant itch can have a
substantial impact on a patient’s sleep and overall quality of
life.1
About the Phase 2 Study (NCT05061693)
This randomized, double-blind, placebo-controlled Phase 2
clinical trial is designed to evaluate the safety and efficacy of
povorcitinib (INCB54707) in adult patients with prurigo nodularis
(PN), over 16 weeks, followed by a 24-week extension. The study
consists of 146 adult patients (age ≥ 18 years) diagnosed with PN
who have had inadequate response or are intolerant to prior PN
therapy.
The primary outcome measure of the study is proportion of
participants achieving ≥ 4-point improvement in itch Numerical
Rating Scale (NRS) score over 16 weeks. The secondary outcome
measures include proportion of participants achieving
Investigator's Global Assessment Treatment Success (IGA-TS) at Week
16, the proportion of patients achieving both IGA-TS and a ≥
4-point improvement from baseline in itch NRS score assessed up to
Week 16 and number of participants experiencing treatment-emergent
adverse events (TEAEs), assessed up to Week 16.
For more information about the study, please visit
https://classic.clinicaltrials.gov/ct2/show/NCT05061693.
About Povorcitinib (INCB54707)
Povorcitinib (INCB54707) is an oral small-molecule JAK1
inhibitor currently in Phase 3 clinical trials for hidradenitis
suppurativa (HS) and vitiligo. A Phase 3 trial is being planned for
prurigo nodularis (PN). Phase 2 studies of povorcitinib in PN,
asthma and chronic spontaneous urticaria 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
A global biopharmaceutical company on a mission to Solve On.,
Incyte follows the science to find solutions for patients with
unmet medical needs. Through the discovery, development and
commercialization of proprietary therapeutics, Incyte has
established a portfolio of first-in-class medicines for patients
and a strong pipeline of products in Oncology and Inflammation
& Autoimmunity. Headquartered in Wilmington, Delaware, Incyte
has operations in North America, Europe and Asia. For additional
information on Incyte, please visit Incyte.com or follow us on
social media: LinkedIn, X, Instagram, Facebook, YouTube.
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 our current
expectations and are 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 and the
ability to enroll subjects in accordance with planned schedules;
determinations made by the FDA and regulatory agencies outside of
the United States; the efficacy or safety of our products; the
acceptance of our products in the marketplace; market competition;
unexpected variations in the demand for our products and the
products of our collaboration partners; the effects of announced or
unexpected price regulation or limitations on reimbursement or
coverage for our products; sales, marketing, manufacturing, and
distribution requirements, including our ability to successfully
commercialize and build commercial infrastructure for newly
approved products and any additional new products that become
approved; and other risks detailed from time to time in our reports
filed with the U.S. Securities and Exchange Commission, including
our quarterly report on Form 10-Q for the quarter ended December
31, 2023. We disclaim any intent or obligation to update these
forward-looking statements.
1 National Organization for Rare Disorders. Prurigo Nodularis.
https://rarediseases.org/rarediseases/prurigo-nodularis/. Accessed
on February 7, 2024. 2 Yale Medicine. Prurigo Nodularis.
https://www.yalemedicine.org/conditions/prurigo-nodularis-overview.
Accessed February 7, 2024.
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