MoonLake
Immunotherapeutics achieves
landmark milestone with positive
Phase 2 results for Nanobody®
sonelokimab in hidradenitis suppurativa
- First
placebo-controlled randomized trial in HS to report positive
topline results using HiSCR75 as the primary endpoint
- Primary endpoint
HiSCR75 met with 29 percentage points (ppt) delta vs placebo
(p=0.0002) at week 12, setting a new bar in HS
- HiSCR50 met with
38 ppt delta vs placebo (p<0.0001), greater delta than observed
for any other molecules
- Other secondary
endpoints also reached statistical significance with clinically
meaningful improvements at week 12, including HiSCR90, IHS4 and
various patient reported outcomes
- Safety results
of sonelokimab consistent with previously reported studies with no
new observed safety signals
- These topline
data will be discussed on Monday 26th June, at 2pm CEST/8am EDT,
via webcast (registration link below)
ZUG, Switzerland, June 25, 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 MIRA trial evaluating the
efficacy and safety of the Nanobody® sonelokimab in patients with
moderate-to-severe hidradenitis suppurativa (HS).
The MIRA trial (M1095-HS-201), which recruited
234 patients, is the first randomized, double-blind,
placebo-controlled trial to use Hidradenitis Suppurativa Clinical
Response (HiSCR) 75 as its primary endpoint, a higher measure of
clinical response versus the HiSCR50 measure used in other clinical
trials, therefore representing a landmark milestone in HS clinical
development.
The trial met its primary endpoint with a
significantly greater proportion of patients treated with both
sonelokimab 120mg and 240mg achieving HiSCR75 compared to those on
placebo at week 12. The primary analysis was based on the most
stringent type of analysis for such trials, intent-to-treat
non-responder imputation (ITT-NRI). Both doses performed similarly,
with the 120mg dose providing the highest delta on HiSCR75 and
HiSCR50. The 120mg dose achieved a 29 ppt delta to placebo on
HiSCR75 (p=0.0002) and a 38ppt delta to placebo on HiSCR50
(p<0.0001). The results suggest that, as early as week 12, the
Nanobody® sonelokimab, relative to placebo, reaches the highest
clinical activity among all other therapies tested in similarly
stringent pivotal-like trials.
In addition, other clinically relevant secondary
endpoints, such as HiSCR90, improvements in International
Hidradenitis Suppurativa Severity Score System (IHS) 4,
abscess/nodule and draining tunnel counts as well as patient
reported pain and quality of life outcomes also reached statistical
significance at week 12. The high performance of the Nanobody® at
120mg, the dose found to be optimal in psoriasis, demonstrates the
advantage of using a smaller biologic with albumin-binding capacity
to inhibit IL-17A and IL-17F for the treatment of inflammatory
diseases.
The safety profile of sonelokimab was consistent
with previously reported studies with no new safety signals
observed. Overall, sonelokimab continues to show a favorable safety
profile, in line with the known profile of IL-17 inhibitors.
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 an ambitious goal for our Nanobody®
sonelokimab to ‘meet or beat’ the best results shown in
pivotal-like trials of competitors. We have achieved our ‘beat’
goal with the positive outcome of the Phase 2 MIRA trial. In doing
so, we have raised the bar for what can be accomplished for HS and
these positive topline data provide us with even greater confidence
as we look forward to our next steps and our aspiration to become a
leader in the inflammation and immunology space.”
Kristian
Reich, MD, PhD,
Founder and Chief Scientific Officer at MoonLake,
commented: “The positive topline results from the
MIRA trial establish a new era in the treatment of chronic
inflammatory diseases, as our Nanobody® sonelokimab indicates a new
bar versus what was achieved previously with monoclonal antibodies.
Importantly, the results confirm the advantage of the Nanobody’s
smaller size versus traditional antibodies in the treatment of
diseases in which high-level improvements depend on optimal tissue
penetration such as hidradenitis suppurativa and likely psoriatic
arthritis. The data also validate sonelokimab’s unique mode of
action to efficiently inhibit IL-17F in addition to IL-17A. The
positive outcome of the MIRA trial would not have been possible
without the support and participation of the patients and
investigators to whom we are grateful.”
Alexa B. Kimball, MD, MPH,
lead investigator of the MIRA trial, investigator
at Beth Israel Deaconess Medical Center, Massachusetts, US, and
Professor of Dermatology at Harvard Medical School,
added: “Hidradenitis suppurativa is a
chronic, inflammatory, recurrent, and debilitating skin disease
that has profound and wide-ranging impacts across many aspects of
patient’s lives. As a physician, I see tremendous need for new
treatment options for people living with HS, particularly for
treatments to reach high thresholds of response in clinical trials
(e.g., HiSCR75 and beyond). The positive high clinical responses
observed with sonelokimab in the Phase 2 MIRA trial are
encouraging, demonstrating its promise as a potential future
treatment option.”
These topline data will be discussed on Monday
June 26, 2023 at 2pm CEST/8am EDT before the Nasdaq market opens,
via webcast at:
https://onlinexperiences.com/Launch/QReg/ShowUUID=AF1A77F1-F560-4D58-AE3B-00698698C741&LangLocaleID=1033&GroupID=Onyx
A replay of the webcast and the presentation
document will be made available at https://ir.moonlaketx.com.
The MIRA 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 switching to sonelokimab from the placebo and the
adalimumab arms. Full results from the MIRA trial will be submitted
for publication in a peer-reviewed medical journal and for
presentation at an upcoming scientific meeting.
Sonelokimab has already been successfully
assessed in a randomized, placebo-controlled, Phase 2b trial
(NCT03384745) in 313 patients with moderate-to-severe plaque-type
psoriasis in which it demonstrated a rapid and durable skin
clearance (PASI100) with no unexpected safety findings.
Sonelokimab is currently being evaluated in a
Phase 2 trial (NCT05640245), ‘ARGO’, in patients with active
psoriatic arthritis with the primary end-point readout expected in
Q4 this year.
Sonelokimab is not yet approved for use in any
indication.
- Ends
-
About the MIRA
trial
The MIRA trial (M1095-HS-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
moderate-to-severe hidradenitis suppurativa. The trial recruited
234 patients, with the aim to evaluate two different doses of
sonelokimab (120mg and 240mg) with placebo control and adalimumab
as an active reference arm. The primary endpoint of the trial is
the percentage of participants achieving Hidradenitis Suppurativa
Clinical Response 75 (HiSCR75), defined as a ≥75% reduction in
total abscess and inflammatory nodule (AN) count with no increase
in abscess or draining tunnel count relative to baseline. The trial
also evaluated a number of secondary endpoints, including the
proportion of patients achieving HiSCR50, the change from baseline
in International Hidradenitis Suppurativa Severity Score System
(IHS4), the proportion of patients achieving a Dermatology Life
Quality Index (DLQI) total score of ≤5, and the proportion of
patients achieving at least 30% reduction from baseline in
Numerical Rating Scale (NRS30) in the Patient’s Global Assessment
of Skin Pain (PGA Skin Pain). Further details are available at:
https://www.clinicaltrials.gov/ct2/show/NCT05322473 .
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.
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 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 has been assessed in a randomized,
placebo-controlled Phase 2b study in 313 patients with
moderate-to-severe plaque-type psoriasis. Sonelokimab demonstrated
a rapid and durable clinical response (Investigator’s Global
Assessment Score 0 or 1, Psoriasis Area and Severity Index 90/100)
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 study 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). Currently, a
global phase 2 trial in psoriatic arthritis (NCT05640245,
M1095-PSA-201, “ARGO”) including multiple arms and over 200
patients is ongoing (announced on Dec 14, 2022).
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. 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-17F-mediated inflammation as a key driver of the pathogenesis of
HS, with other identified risk factors including genetics,
cigarette smoking, and obesity.
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 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 such 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
Consilium Strategic
CommunicationsMary-Jane Elliott, Namrata Taak, Genevieve
WilsonTel: +44 (0) 20 3709
5700media@moonlaketx.comMoonLake@consilium-comms.com
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