MoonLake Immunotherapeutics announces
landmark Phase 2 results for Nanobody®
sonelokimab in active psoriatic arthritis
- First
placebo-controlled randomized trial in active psoriatic arthritis
(PsA) using a Nanobody® to report positive topline results in
support of potential best-in-class profile
- Primary endpoint
ACR50 met with up to 47% (p<0.01 versus placebo) of patients on
sonelokimab achieving ACR50 as early as week 12
- All key
secondary endpoints met including up to 77% (p<0.001 versus
placebo) of patients on sonelokimab achieving PASI90 as early as
week 12
- Other secondary
endpoints also reached statistical significance at week 12,
including endpoints focused on deep tissue inflammation, Minimal
Disease Activity (MDA) and patient reported outcomes
- High threshold
outcomes, including ACR70 and PASI100, continue to improve beyond
week 12, consistent with previous studies of sonelokimab
- Discontinuation
rate below 4% and safety results of sonelokimab consistent with
previously reported studies with no new safety signals
- The top-line data will be discussed
on Monday 6 November, at 2pm CET/8am ET, via webcast (registration
link below)
ZUG, Switzerland, November 5,
2023 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a
clinical-stage biotechnology company focused on creating next-level
therapies for inflammatory diseases, today announced positive
top-line results from its global Phase 2 ARGO trial evaluating the
efficacy and safety of the Nanobody® sonelokimab in patients with
active psoriatic arthritis (PsA).
The ARGO trial (M1095-PSA-201), which enrolled
207 patients, met its primary endpoint with a statistically
significant greater proportion of patients treated with either
sonelokimab 60mg or 120mg (with induction) achieving an American
College of Rheumatology (ACR) 50 response compared to those on
placebo at week 12. Specifically, for the 60mg and 120mg doses with
induction, respectively, 46% and 47% of patients treated with
sonelokimab achieved ACR50 (p<0.01 versus placebo); 78% and 72%
of patients achieved ACR20; and 29% and 26% achieved ACR70. The
primary analyses were based on the most stringent type of analysis
for such trials, intention-to-treat with non-responder imputation
(ITT-NRI). As expected, the 60mg dose without induction did not
reach statistical significance, confirming the 60mg and 120mg with
induction as the potential dose regimens to carry forward into
Phase 3.
All key secondary endpoints were met for the
60mg and 120mg doses with induction. The key secondary endpoint
Psoriasis Area and Severity Index (PASI) 90 was met for all doses
with induction; 77% of patients responding at week 12 to the 60mg
dose (ITT-NRI, p<0.001 versus placebo). For this dose, 58% of
patients achieved complete skin clearance (PASI100) at week 12.
PASI responses across dose arms were consistent with the previously
reported Phase 2b data of sonelokimab in moderate-to-severe
plaque-type psoriasis, with the 120mg dose achieving the highest
responses for PASI100 (close to 60% of patients at week 12,
ITT-NRI) in patients with more severe skin lesions (PASI score ≥ 10
at baseline).
Other clinically relevant secondary endpoints,
such as Minimal Disease Activity (MDA), the modified Nail Psoriasis
Severity Index (mNAPSI), the Leeds Enthesitis Index (LEI) and the
patient self-reported Psoriatic Arthritis Impact of Disease
(PsAID-12), each show promising levels of response at week 12.
Jorge Santos da Silva, PhD, Founder and
Chief Executive Officer at MoonLake, said: “As part of our
efforts to elevate outcomes for patients, we set ambitious goals
for our Nanobody® sonelokimab. ARGO is MoonLake’s third Phase 2
trial and the first trial in psoriatic arthritis using a Nanobody®
to report positive topline results, setting another landmark
milestone. Again, we met the objectives we set out for ourselves,
in this case for PsA. As with our hidradenitis suppurativa program,
the preparation of our Phase 3 program in PsA is rapidly advancing
and expected timing of end-of-Phase 2 regulatory meetings will be
announced in due course.”
Adalimumab was used as an active reference to
validate responses across arms (not powered for statistical
comparisons to active treatment). Sonelokimab 60mg and 120mg (with
induction) numerically outperformed adalimumab on the primary
endpoint and all key secondary endpoints, with the observed deltas
further supporting the potential for sonelokimab as a future
leading therapy.
The patient discontinuation rate in the ARGO
trial was low at week 12 (less than 4%), similar to what was
observed in previous trials of sonelokimab in psoriasis and
hidradenitis suppurativa. The safety profile of sonelokimab in ARGO
was consistent with previously reported studies with no new safety
signals. Specifically, oral candidiasis was observed in less than
2% of patients on sonelokimab, with no case leading to
discontinuation. No cases of inflammatory bowel disease (IBD),
major adverse cardiovascular events (MACE) or suicidal ideation and
behavior (SI/B) were observed. Overall, sonelokimab continues to
show a favorable safety profile. Across the sonelokimab clinical
program to date, the company has not seen any signal of SI/B or
liver enzyme elevations related to sonelokimab treatment.
The results suggest that, as early as week 12,
the Nanobody® sonelokimab reaches levels of clinical response at or
above those seen with other therapies tested in similarly stringent
trials. The high performance of sonelokimab and its favorable
safety profile continue to support the potential of using a smaller
biologic with albumin-binding capacity to inhibit IL-17A and IL-17F
for the treatment of inflammatory diseases.
Kristian Reich, MD, PhD,
Founder and Chief Scientific Officer at MoonLake,
commented: “The positive topline results from the
pivotal-like ARGO trial establish the Nanobody® sonelokimab as an
innovative potential treatment in another chronic inflammatory
disease, psoriatic arthritis. Importantly, the results confirm our
expectations in terms of dosing, clinical responses and safety
findings. We believe that we have elevated the therapeutic bar by
reaching important clinical outcomes at week 12. The data also
support sonelokimab’s unique molecule characteristics and mode of
action to effectively inhibit IL-17F in addition to IL-17A in deep
tissue inflammation. The positive outcome of the ARGO trial would
not have been possible without the support and participation of the
patients and investigators to whom we are grateful.”
Joseph F. Merola, MD, MMSc, Professor of
Dermatology, Medicine and Rheumatology, Distinguished Chair of
Dermatology at UT Southwestern Medical Center added:
“Psoriatic arthritis is a chronic, inflammatory, recurrent, and
debilitating multidomain disease that has profound and wide-ranging
impacts across many aspects of patients’ lives. As a physician, I
see tremendous need for new treatment options for people living
with PsA, particularly for therapies that reach high thresholds of
response (e.g., ACR70, PASI100) and that simultaneously improve the
disease domains that matter most for patients. The positive high
clinical responses across joint and skin endpoints and stringent
composite measures such as minimal disease activity observed with
sonelokimab as early as week 12 in the Phase 2 ARGO trial are
encouraging, demonstrating its promise as a potential future
treatment option.”
These topline data will be discussed on Monday
November 6, 2023 at 2pm CET/8am ET before the Nasdaq market opens,
via webcast at:
https://edge.media-server.com/mmc/p/bp43a4xr
A replay of the webcast and the presentation
document will be made available at https://ir.moonlaketx.com.
The ARGO trial proceeds to week 24, with a
4-week safety follow-up. Important data is being collected
regarding longer-term efficacy and safety of sonelokimab, as well
as results from the cross-over of patients treated with placebo or
adalimumab to sonelokimab and the continued monthly dosing of
sonelokimab.
Today’s top-line data announcement follows the
announcement in July 2023 that the ARGO trial successfully
completed randomization of its target 200 patients, several weeks
ahead of schedule (read more here). Full results from the ARGO
trial will be submitted for publication in a peer-reviewed medical
journal and for presentation at an upcoming scientific meeting.
The positive top-line12-week results from the
Phase 2 ARGO trial in PsA follows the positive top-line 12-week and
24-week results from the Phase 2 MIRA trial in hidradenitis
suppurativa (HS) as announced in June 2023 (read more here) and
October 2023 (read more here). The MIRA trial set a landmark
milestone as the first placebo-controlled randomized trial in HS to
report positive top-line results using HiSCR75 as the primary
endpoint.
Sonelokimab is not yet approved for use in any
indication.
- Ends -
About Psoriatic
Arthritis
Psoriatic arthritis (PsA) is a chronic and
progressive inflammatory arthritis associated with psoriasis
primarily affecting the peripheral joints. The clinical features of
PsA are diverse, involving pain, swelling, and stiffness of the
joints, which can result in restricted mobility and
fatigue. PsA occurs in up to 30% of patients with psoriasis,
most commonly those aged between 30 and 60 years. The symptom
burden of PsA can have a substantial negative impact on patient
quality of life. 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 the ARGO
trial
The ARGO trial
(M1095-PSA-201) is a global, randomized, double-blind,
placebo-controlled trial to evaluate the efficacy and safety of the
Nanobody® sonelokimab, administered subcutaneously, in the
treatment of adult patients with active PsA. The trial is designed
to evaluate different doses of sonelokimab, with placebo control
and adalimumab as an active reference arm. The primary endpoint of
the trial is the percentage of participants achieving ≥50%
improvement in signs and symptoms of disease from baseline,
compared to placebo, as measured by the American College of
Rheumatology (ACR) 50 response. The trial also evaluates a number
of secondary endpoints, including improvement compared to placebo
in ACR20, complete skin clearance as measured by at least a 100%
improvement in the Psoriasis Area and Severity Index (PASI),
physical function as measured by the Health Assessment
Questionnaire-Disability Index, enthesitis as measured by the Leeds
Enthesitis Index and pain as measured by the Patients Assessment of
Arthritis Pain. Further details are available on:
https://clinicaltrials.gov/ct2/show/NCT05640245
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 trials, the Phase 2 ARGO trial in PsA (trial
ongoing) and the Phase 2 MIRA trial in HS. 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 clinically relevant outcomes.
Sonelokimab has also
been assessed in a randomized, placebo-controlled Phase 2b trial
(NCT03384745) in 313 patients with moderate-to-severe plaque-type
psoriasis. Clinical response (considering the Investigator’s Global
Assessment Score 0 or 1, and the Psoriasis Area and Severity Index
90/100) was 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
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 IL-17F/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. The terms Nanobody® and Nanobodies® are
trademarks of Ablynx, a Sanofi company.
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 clinical trials and
research and development programs; and the anticipated timing of
the results from those trials, including completing the MIRA trial
and top-line data from the ARGO trial; and the efficacy of our
products, if approved, including in relation to other products. 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, and reliance on third
parties to conduct and support its 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, 2022 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
InvestorsMatthias Bodenstedt, CFOinfo@moonlaketx.com
MoonLake Immunotherapeutics
MediaPatricia Sousamedia@moonlaketx.com
ICR Consilium Mary-Jane
Elliott, Namrata Taak, Ashley TappTel: +44 (0) 20 3709
5700media@moonlaketx.comMoonLake@consilium-comms.com
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