- Results from open-label extension period of
the Phase 2 trial demonstrate that longer-term treatment with
povorcitinib 75 mg resulted in sustained and durable efficacy
across all treatment arms
- Data featured as an oral presentation at the
European Hidradenitis Suppurativa Foundation conference
- Hidradenitis suppurativa (HS) is a chronic
and debilitating inflammatory skin condition characterized by
painful nodules and abscesses that can lead to irreversible tissue
destruction and scarring1
Incyte (Nasdaq:INCY) today announced new 52-week results from a
Phase 2 study evaluating the efficacy and safety of povorcitinib
(formerly INCB54707), an oral JAK1 inhibitor, in adult patients
with hidradenitis suppurativa (HS). These data were presented as an
oral presentation (Abstract #258) at the 12th Conference of the
European Hidradenitis Suppurativa Foundation, held from February
8-10, 2023, in Florence, Italy.
The study previously met its primary endpoint, demonstrating
that at Week 16 – the double-blind, placebo-controlled portion of
the study – patients receiving povorcitinib once daily (QD) had
significantly greater decreases from baseline in Abscess and
Inflammatory Nodule (AN) count versus placebo (least squares mean
change, −2.5 [0.9], placebo vs. −5.2 [0.9], P=0.0277, povorcitinib
15 mg; −6.9 [0.9], P=0.0006, povorcitinib 45 mg; −6.3 [0.9],
P=0.0021), povorcitinib 75 mg)2.
New results at Week 52, which include the 36-week open-label
extension period during which all patients received povorcitinib 75
mg once daily (QD), show that average efficacy was sustained for
all treatment arms following the switch to povorcitinib 75 mg QD
(mean change in AN count from Day 1 baseline at Week 52 was −5.7
[7.3], placebo→75 mg; −8.4 [5.6], 15→75 mg; −10.4 [14.6], 45→75 mg;
and −5.4 [5.6], 75 mg). Importantly, povorcitinib also demonstrated
durable efficacy at Week 52 in high-threshold outcomes, as
evidenced by 22-29% of patients achieving HS Clinical Response 100
(HiSCR100), which is defined as a 100% reduction from baseline in
total AN count with no increase from baseline in abscess or
draining tunnel count.
Povorcitinib was generally well tolerated and the safety profile
was consistent with previously-reported data. The most common
treatment-emergent adverse events (TEAEs) at Week 52 (n=174) were
COVID-19 (21.3%), acne (11.5%), upper respiratory tract infection
(10.9%), headache (5.7%), nasopharyngitis (5.7%), urinary tract
infection (5.7%) and increased blood creatine kinase (CK) (5.2%).
In total, six patients (3.4%) experienced a TEAE that led to
treatment discontinuation. No fatal TEAEs were observed.
“HS is a chronic, progressive and debilitating condition for
which there is no cure. We are encouraged by these Phase 2 data and
believe they reinforce the potential of povorcitinib to be a safe
and efficacious treatment for HS that is tolerable with longer-term
administration, even at the higher doses,” said Kurt Brown, M.D.,
Global Program Head, Povorcitinib, and Associate Vice President,
Drug Development, Inflammation & AutoImmunity, Incyte. “Despite
the available treatments for HS, no uniformly-effective therapy has
been found, underscoring the need for additional options. We look
forward to continuing to progress the development of povorcitinib
through our ongoing Phase 3 trial in patients with
moderate-to-severe HS.”
Additional 52-week efficacy results include:
Placebo → Povorcitinib
75 mg arm
Povorcitinib 15 → 75 mg
arm
Povorcitinib 45 → 75 mg
arm
Povorcitinib 75 mg arm
(Patients, %)
(Patients, %)
(Patients, %)
(Patients, %)
HiSCR
59.3
64.7
66.7
61.3
HiSCR75
40.7
50.0
50.0
51.6
HiSCR90
25.9
35.3
33.3
32.3
HiSCR100
22.2
29.4
23.3
29.0
(Patients, %)
(Patients, %)
(Patients, %)
(Patients, %)
ISH4-55
59.3
73.5
76.7
61.3
ISH4-75
51.9
55.9
60.0
45.2
ISH4-90
37.0
35.3
30.0
32.3
ISH4-100
22.2
29.4
20.0
25.8
HiSCR, HS Clinical Response – ≥50%
reduction from baseline in AN count with no increase in the number
of abscesses or draining tunnels; HiSCR75/90/100, ≥75%, ≥90%, and
100% reduction from baseline in AN count with no increase in the
number of abscesses or draining tunnels; ISH4, International
Hidradenitis Suppurativa Severity Score System; IHS455/75/90/100,
≥55%/75%/90%/100% reduction from baseline in IHS4 score.
“Given the nature of HS, which presents with persistent, painful
nodules and abscesses, this immune-mediated skin condition often
has a severe impact on a patient’s quality of life,” said Joslyn
Kirby, M.D., M.S., M.Ed., Associate Professor and Vice Chair for
Education, Department of Dermatology at Penn State Health. “I am
encouraged by these promising results suggesting that povorcitinib
may be a favorable oral treatment option that could provide
substantial relief from common HS symptoms for patients.”
This presentation will be made available for registered
participants on the EHSF website at
https://www.eventclass.org/contxt_ehsf2023/scientific/online-program/session?s=S-09#e268
and can be accessed until August 31, 2023.
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic inflammatory skin
condition characterized by painful nodules and abscesses that can
lead to irreversible tissue destruction and scarring.1
Over-activity of the JAK/STAT signaling pathway is believed to
drive inflammation involved in the pathogenesis and progression of
HS3. More than 150,000 patients in the U.S. are estimated to have
moderate to severe HS4. Given the debilitating nature of condition,
it can have a profoundly negative effect on patients’ quality of
life5.
About the Phase 2 Study (NCT04476043)
This Phase 2, randomized, double-blind, placebo-controlled,
dose-ranging study is evaluating the efficacy and safety of
povorcitinib (formerly INCB54707) in adult patients with
hidradenitis suppurativa (HS).
The first part of the study spanned 16 weeks and enrolled 209
adults (aged 18-75 years) who were randomized 1:1:1:1 to
povorcitinib 15 mg once daily (QD; n=52), 45 mg QD (n=52), 75 mg QD
(n=53) or placebo (n=52). Eligible patients had an HS (Hurley stage
I, II or III) disease duration of ≥3 months prior to screening, and
active HS in at least two distinct anatomical areas. The primary
efficacy endpoint is mean change from baseline in Abscess and
Inflammatory Nodule (AN) count at Week 16. The key secondary
endpoint is percentage of patients achieving HS Clinical Response
(HiSCR; ≥50% reduction from baseline in AN count with no increase
in number of abscesses or draining tunnels) at Week 16.
The second part of the study, the open-label extension (OLE)
period, spanned an additional 36 weeks (52 weeks total) and
included patients enrolled in the first part of the study. All OLE
patient participants (n=174) received treatment with povorcitinib
75 mg QD. After Week 52, patients who completed baseline, Week 16
and Week 52 assessments could continue to receive open-label
treatment with povorcitinib 75 mg QD for an additional 48
weeks.
Endpoints at Week 52 include mean change from baseline in AN
count, HiSCR and HiSCR75/90/100 (≥75%/90%/100% reduction from
baseline in AN count with no increase in the number of abscesses or
draining tunnels), HS flare occurrence, mean change from baseline
in International Hidradenitis Suppurativa Severity Score System
(IHS4) and IHS455/75/90/100 (≥55%/75%/90%/100% reduction from
baseline in IHS4 score). Safety of povorcitinib was assessed by the
frequency and severity of treatment-emergent adverse events
(TEAEs).
For more information about this Phase 2 study, please visit
https://clinicaltrials.gov/ct2/show/NCT04476043.
About Povorcitinib (INCB54707)
Povorcitinib (INCB54707) is an oral small-molecule JAK1
inhibitor currently in Phase 2 clinical trials for hidradenitis
suppurativa (HS), vitiligo and prurigo nodularis. A Phase 3 study
in HS is also ongoing.
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 National Center for Advancing
Translational Science Genetic and Rare Diseases Information Center.
“Hidradenitis suppurativa.” Available at:
https://rarediseases.info.nih.gov/diseases/6658/hidradenitis-suppurativa
2 Kirby J, et al. Efficacy and Safety of the Janus Kinase 1
Inhibitor Povorcitinib (INCB054707) in Patients with Hidradenitis
Suppurativa: Results from a Randomized, Placebo-Controlled, Phase 2
Dose-Ranging Study. Presented at the 31st European Academy of
Dermatology and Venereology (EADV) Congress, September 7-10, 2022.
3 Solimani, F., Meier, K., & Ghoreschi, K. (2019). Emerging
topical and systemic JAK inhibitors in dermatology. Frontiers in
immunology, 10, 2847. 4 McMillan, K. Hidradenitis suppurativa:
number of diagnosed patients, demographic characteristics, and
treatment patterns in the United States. Am J Epidemiol. 2014 Jun
15;179(12):1477-83. doi: 10.1093/aje/kwu078. Epub 2014 May 8. 5
Sabat, R., Jemec, G. B., Matusiak, Ł., Kimball, A. B., Prens, E.,
& Wolk, K. (2020). Hidradenitis suppurativa. Nature reviews
Disease primers, 6(1), 18.
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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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