MoonLake Immunotherapeutics starts Phase
3 IZAR program of the Nanobody® sonelokimab in patients with active
psoriatic arthritis
- Two trials for
active psoriatic arthritis (PsA) with one focusing on
biologic-naïve patients and including evaluation of radiographic
progression (IZAR-1), and the other focusing on TNF-IR patients
while being the first trial to include risankizumab as an active
reference arm (IZAR-2)
- Program will
evaluate sonelokimab for a total of 52 weeks, across IZAR-1 and
IZAR-2, at sites in the United States, Europe and Latin America,
using a design informed by the Phase 2 ARGO trial
- The IZAR program
builds upon the Phase 3 VELA program for sonelokimab in
hidradenitis suppurativa (HS) which started in May
- The topline
primary endpoint readout at week 16 for the program is expected in
H1 2026
Zug, Switzerland, November 13,
2024 – MoonLake Immunotherapeutics (MoonLake; Nasdaq: MLTX), a
clinical-stage biotechnology company focused on creating next-level
therapies for inflammatory diseases, today announced that the first
patients have been screened at U.S. trial sites in its global Phase
3 clinical program, IZAR, evaluating sonelokimab, an
investigational Nanobody® designed to treat inflammatory disease,
in patients with active psoriatic arthritis (PsA).
PsA is a chronic, debilitating and progressive
inflammatory condition that not only affects the peripheral joints
and skin but also other domains such as entheses, nails and axial
joints. This multi-domain disease presents with significant unmet
needs, especially in managing inflammation and pain across multiple
domains simultaneously. Although the exact mechanisms underlying
PsA are not fully understood, evidence indicates that activation of
the IL-17 pathway plays a crucial role in its pathophysiology.
Sonelokimab, a Nanobody®, is designed to directly target sites of
inflammation by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F
dimers. Its smaller size as a Nanobody® compared to antibodies
allows it to better penetrate and treat difficult-to-reach inflamed
tissues.
Following the positive results from the Phase 2
ARGO trial, the Phase 3 IZAR program is expected to enroll
approximately 1,500 adult patients across two trials, IZAR-1
(NCT06641076) and IZAR-2 (NCT06641089). The global, randomized,
double-blind placebo-controlled IZAR trials are designed to
evaluate the efficacy and safety of the Nanobody® sonelokimab over
52 weeks. IZAR-1 will enroll biologic-naïve patients and include an
evaluation of radiographic progression, while IZAR-2 will enroll
patients with an inadequate response to tumor necrosis factor-α
inhibitors (TNF-IR) and will be the first to include risankizumab,
a monoclonal antibody that inhibits IL-23, as an active reference
arm. The primary endpoint (American College of Rheumatology (ACR)
50) compared to placebo, and key secondary endpoints for both
trials are expected to read out at Week 16. The IZAR program will
assess 60mg and 120mg doses of sonelokimab. The readout of the
primary endpoint for both IZAR-1 and IZAR-2 is anticipated in H1
2026.
Alan Kivitz, MD, MACR, ARGO and IZAR
Investigator commented: “I’m excited to be part of the
Phase 3 IZAR program as an investigator, focusing on the Nanobody®
sonelokimab for psoriatic arthritis. This initiative marks a
crucial advancement in addressing the urgent need for more
treatment options for those suffering from this complex and
debilitating multi-domain condition. The Phase 2 ARGO trial yielded
particularly promising results, with strong responses across
multiple domains including joints, skin, and nails. This robust
multi-domain efficacy resulted in up to 61% of patients achieving
Minimal Disease Activity – an important treatment goal that can
significantly improve patients’ quality of life – by Week
24. The IZAR program seeks to confirm the effectiveness of
sonelokimab in treating PsA, with the ultimate goal of helping more
patients reach their treatment goals across multiple domains.”
Philip J. Mease, MD, Director of
Rheumatology Research at the Providence Swedish Medical Center and
Clinical Professor at the University of Washington School of
Medicine, Seattle, WA, U.S commented: “MoonLake’s
Nanobody®, Sonelokimab is designed to precisely target challenging
sites of inflammation by integrating Nanobody® innovation with the
dual inhibition of IL-17F and IL-17A – a novel and promising
clinical approach that may allow enhanced treatment of the multiple
domains of PsA compared with conventional
antibodies. Sonelokimab has already shown promising outcomes,
with robust clinical efficacy observed across key psoriatic
arthritis disease domains. The Phase 3 IZAR program is therefore an
exciting opportunity to determine whether the novel design of
sonelokimab can raise the current treatment bar in psoriatic
arthritis.”
Kristian Reich, Founder and Chief
Scientific Officer at MoonLake commented: “This is a major
milestone for MoonLake, marking the second Phase 3 program
independently initiated by the company this year. The launch of our
Phase 3 IZAR program underscores our dedication to advance the
field of inflammation and immunology not only in dermatology but
also in rheumatology and to provide novel treatment options for
patients with high unmet need. We are in full execution mode with
our late-stage clinical development plans and look forward to
reporting the primary endpoint in H1 2026.”
The initiation of this Phase 3 program follows
the announcement in June 2024 of the successful outcome of
MoonLake’s end-of-Phase 2 interactions with the U.S. Food and Drug
Administration (FDA), as well as positive feedback from its
interactions with the European Medicines Agency (EMA).
- Ends –
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic,
progressive and complex inflammatory disease that manifests across
multiple domains, leading to substantial functional impairment and
decreased quality of life. The clinical features of PsA are
diverse, comprising both musculoskeletal (peripheral arthritis,
spondylitis, dactylitis, and enthesitis) and non-musculoskeletal
(skin and nail disease) domains. PsA occurs in up to 30% of
patients with psoriasis, most commonly those aged between 30 and 60
years. Although the exact mechanism of disease is not fully
understood, evidence suggests that activation of the IL-17 pathway
plays an important role in the disease pathophysiology.
About IZAR
IZAR-1 (NCT06641076) and IZAR-2 (NCT06641089)
are global, randomized, double-blind, placebo-controlled Phase 3
trials designed to evaluate the efficacy and safety of sonelokimab
compared with placebo in a total of approximately 1,500 adults with
active PsA, with a primary endpoint of superiority to placebo in
ACR 50 response at Week 16. IZAR-1 will enroll biologic-naïve
patients and include an evaluation of radiographic progression,
while IZAR-2 will enroll patients with an inadequate response to
tumor necrosis factor-α inhibitors (TNF-IR) — reflecting patients
commonly seen in clinical practice — and will be the first PsA
trial to include a risankizumab active reference arm. Both trials
will also assess a range of secondary endpoints reflecting the
multiple disease manifestations characteristic of PsA. These
include skin and nail outcomes, multidomain outcomes, and
patient-reported outcome measures such as pain and quality of life
assessments.
About Sonelokimab
Sonelokimab (M1095) is an investigational ~40
kDa humanized Nanobody® consisting of three VHH domains covalently
linked by flexible glycine-serine spacers. With two domains,
sonelokimab selectively binds with high affinity to IL-17A and
IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F
dimers. A third central domain binds to human albumin, facilitating
further enrichment of sonelokimab at sites of inflammatory
edema.
Sonelokimab is being assessed in two lead
indications, HS and PSA, and MoonLake is pursuing other indications
in dermatology and rheumatology.
For HS, sonelokimab is being assessed in the
Phase 3 trials, VELA-1 and VELA-2, following the successful outcome
of MoonLake’s end-of-Phase 2 interactions with the FDA and as well
as positive feedback from its interactions with the EMA announced
in February 2024. In June 2023, topline results of the MIRA trial
(NCT05322473) at 12 weeks showed that the trial met its primary
endpoint, the Hidradenitis Suppurativa Clinical Response (HiSCR)75,
which is a higher measure of clinical response versus the HiSCR50
measure used in other clinical trials, setting a landmark
milestone. In October 2023, the full dataset from the MIRA trial at
24 weeks showed that maintenance treatment with sonelokimab led to
further improvements in HiSCR75 response rates and other high
threshold clinical and patient relevant outcomes. The safety
profile of sonelokimab in the MIRA trial was consistent with
previous trials with no new safety signals detected.
For PsA, sonelokimab is being assessed in the
Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in
March 2024 of the full dataset from the global Phase 2 ARGO trial
(M1095-PSA-201) evaluating the efficacy and safety of the Nanobody®
sonelokimab over 24 weeks in patients with active PsA. Significant
improvements were observed across all key outcomes, including up to
61% of patients treated with sonelokimab achieving an American
College of Rheumatology (ACR) 50 response and Minimal Disease
Activity (MDA) at week 24. This followed the positive top-line
results in November 2023, where the trial met its primary endpoint
with a statistically significant greater proportion of patients
treated with either sonelokimab 60mg or 120mg (with induction)
achieving ACR50 response compared to those on placebo at week 12.
All key secondary endpoints in the trial were met for the 60mg and
120mg doses with induction. The safety profile of sonelokimab in
the ARGO trial was consistent with previous trials with no new
safety signals detected.
A Phase 2 trial is expected to be initiated in
2024 for palmo-plantar pustulosis (PPP), a debilitating
inflammatory skin condition affecting a significant number of
patients. In addition, in 2024, a Phase 3 trial is expected to be
initiated in adolescent HS, a condition that typically manifests at
this early stage of a patient’s life, and the period in which
irreversible damage and inflammatory remission is most
critical.
Sonelokimab will also be assessed in
seronegative spondyloarthritis with Phase 2 trials in radiographic
and non-radiographic axial spondyloarthritis (axSpA) and PsA. The
trials are set to incorporate innovative designs that enhance
traditional clinical outcomes with contemporary tissue and cellular
imaging techniques.
Sonelokimab has also been assessed in a
randomized, placebo-controlled Phase 2b trial (NCT03384745) in 313
patients with moderate-to-severe plaque-type psoriasis. High
threshold clinical responses (Investigator’s Global Assessment
Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were
observed in patients with moderate-to-severe plaque-type psoriasis.
Sonelokimab was generally well tolerated, with a safety profile
similar to the active control, secukinumab (Papp KA, et al. Lancet.
2021; 397:1564-1575).
In an earlier Phase 1 trial in patients with
moderate-to-severe plaque-type psoriasis, sonelokimab has been
shown to decrease (to normal skin levels) the cutaneous gene
expression of pro-inflammatory cytokines and chemokines (Svecova D.
J Am Acad Dermatol. 2019;81:196–203).
About Nanobodies®
Nanobodies® represent a new generation of
antibody-derived targeted therapies. They consist of one or more
domains based on the small antigen-binding variable regions of
heavy-chain-only antibodies (VHH). Nanobodies® have a number of
potential advantages over traditional antibodies, including their
small size, enhanced tissue penetration, resistance to temperature
changes, ease of manufacturing, and their ability to be designed
into multivalent therapeutic molecules with bespoke target
combinations.
The terms Nanobody® and Nanobodies® are
trademarks of Ablynx, a Sanofi company.
About Hidradenitis
Suppurativa
Hidradenitis suppurativa is a severely
debilitating chronic skin condition resulting in irreversible
tissue destruction. HS manifests as painful inflammatory skin
lesions, typically around the armpits, groin, and buttocks. Over
time, uncontrolled and inadequately treated inflammation can result
in irreversible tissue destruction and scarring. The disease
affects 0.05–4.1% of the global population, with three times more
females affected than males. Real-world data in the US indicates
that at least 2 million unique patients have been diagnosed with
and treated for HS between 2016 and 2023 alone, highlighting a
significant unmet need and impact on healthcare systems, and a
market opportunity exceeding $10bn by 2035. Onset typically occurs
in early adulthood and HS has a profound negative impact on quality
of life, with a higher morbidity than other dermatologic
conditions. There is increasing scientific evidence to support
IL-17A- and IL-17-mediated inflammation as a key driver of the
pathogenesis of HS, with other identified risk factors including
genetics, cigarette smoking, and obesity.
About MoonLake
Immunotherapeutics
MoonLake Immunotherapeutics is a clinical-stage
biopharmaceutical company unlocking the potential of sonelokimab, a
novel investigational Nanobody® for the treatment of inflammatory
disease, to revolutionize outcomes for patients. Sonelokimab
inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F,
and IL17F/F dimers that drive inflammation. The company’s focus is
on inflammatory diseases with a major unmet need, including
hidradenitis suppurativa and psoriatic arthritis – conditions
affecting millions of people worldwide with a large need for
improved treatment options. MoonLake was founded in 2021 and is
headquartered in Zug, Switzerland. Further information is available
at www.moonlaketx.com.
Cautionary Statement Regarding Forward
Looking Statements
This press release contains certain
“forward-looking statements” within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995. Forward-looking
statements include, but are not limited to, statements regarding
MoonLake’s expectations, hopes, beliefs, intentions or strategies
regarding the future including, without limitation, statements
regarding: plans for and timing of clinical trials, including the
topline primary endpoint readout for the Phase 3 IZAR program, the
trial design and patient enrollment across the IZAR-1 and IZAR-2
trials, and the initiation of Phase 2 trials for PPP, adolescent
HS, axSpA and PsA, the efficacy and safety of sonelokimab for the
treatment of HS and PsA, including in comparison to existing
standards or care or other competing therapies, clinical trials and
research and development programs and the anticipated timing of the
results from those studies and trials. In addition, any statements
that refer to projections, forecasts, or other characterizations of
future events or circumstances, including any underlying
assumptions, are forward looking statements. The words
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“intend,” “may,” “might,” “plan,” “possible,” “potential,”
“predict,” “project,” “should,” “would” and similar expressions may
identify forward-looking statements, but the absence of these words
does not mean that statement is not forward looking.
Forward-looking statements are based on current
expectations and assumptions that, while considered reasonable by
MoonLake and its management, as the case may be, are inherently
uncertain. New risks and uncertainties may emerge from time to
time, and it is not possible to predict all risks and
uncertainties. Actual results could differ materially from those
anticipated in such forward-looking statements as a result of
various risks and uncertainties, which include, without limitation,
risks and uncertainties associated with MoonLake’s business in
general and limited operating history, difficulty enrolling
patients in clinical trials, state and federal healthcare reform
measures that could result in reduced demand for MoonLake’s product
candidates and reliance on third parties to conduct and support its
preclinical studies and clinical trials and the other risks
described in or incorporated by reference into MoonLake’s Annual
Report on Form 10-K for the year ended December 31, 2023 and
subsequent filings with the Securities and Exchange Commission.
Nothing in this press release should be regarded
as a representation by any person that the forward-looking
statements set forth herein will be achieved or that any of the
contemplated results of such forward-looking statements will be
achieved. You should not place undue reliance on forward-looking
statements in this press release, which speak only as of the date
they are made and are qualified in their entirety by reference to
the cautionary statements herein. MoonLake does not undertake or
accept any duty to release publicly any updates or revisions to any
forward-looking statements to reflect any change in its
expectations or in the events, conditions or circumstances on which
any such statement is based.
MoonLake Immunotherapeutics
InvestorsCarla Bretes, Director IR &
BDir@moonlaketx.com
MoonLake Immunotherapeutics
MediaPatricia Sousa, Director Corporate
Affairsmedia@moonlaketx.com
ICR Healthcare Mary-Jane
Elliott, Ashley Tapp, Namrata TaakTel: +44 (0) 20 3709
5700MoonLake@ICRHealthcare.com
- 2024.11.13 MLTX - Phase 3 IZAR program PsA start
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