MoonLake Immunotherapeutics presents
positive 12-week data from the Phase 2 MIRA trial
with Nanobody® Sonelokimab for
Hidradenitis Suppurativa at the European Academy of Dermatology and
Venereology Congress
- Peer reviewed data presented during
a late-breaking session at the European Academy of Dermatology and
Venereology Congress (EADV) confirms the strong profile of
sonelokimab in HS announced at MLTX’s R&D Day on June 26,
2023
- HiSCR75 primary
endpoint met with a significantly higher proportion of patients on
sonelokimab 120mg (43.3%) compared to placebo (14.7%) achieving
HiSCR75 at week 12; a 29 percentage points (ppt) delta
(p<0.001)
- HiSCR50
secondary endpoint met with a significantly higher proportion of
patients on sonelokimab 120mg (65.7%) compared to placebo (27.9%)
achieving HiSCR50 at week 12; a 38 ppt delta (p<0.001)
- Sonelokimab
rapidly achieved high levels of response across HiSCR thresholds,
including HiSCR 90 and IHS4, and significant resolution of draining
tunnels (DT 100) compared to placebo
- Sonelokimab also
led to significant improvements in patient-reported quality of
life, skin pain, and HS symptoms compared with placebo, with
additional depth of response reported following additional analysis
after the June R&D Day
- Safety results
of sonelokimab were consistent with previously reported studies
with no new observed signals, and included additional insight
following further analysis after the June R&D Day
- 24-week data from the Phase 2 MIRA
trial is anticipated imminently
ZUG, Switzerland, October
11, 2023 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX),
a clinical-stage biotechnology company focused on creating
next-level therapies for inflammatory diseases, announced that
positive 12-week 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”) were presented today during a
late-breaking session at the European Academy of Dermatology and
Venereology Congress (“EADV”) held in Berlin, Germany.
The EADV presentation follows the announcement,
in June 2023, of the positive topline 12-week results from the
trial in 234 patients, which marked a landmark milestone as the
first placebo-controlled randomized trial in HS to report results
using HiSCR75 as the primary endpoint. The primary analysis was
based on the most stringent type of analysis for such trials,
intent-to-treat non-responder imputation (“ITT-NRI”).
The MIRA trial met its primary endpoint with a
significantly higher proportion of patients treated with both
sonelokimab 120mg (43.3%) and 240mg (34.8%) achieving HiSCR75
compared to those on placebo (14.7%) at week 12. Sonelokimab also
met the key secondary endpoint with a significantly higher
proportion of patients treated with both sonelokimab 120mg (65.7%)
and 240mg (53.0%) achieving HiSCR50 compared to those on placebo
(27.9%) at week 12. Both doses performed similarly, with the 120mg
dose providing the highest delta on HiSCR75 and HiSCR50. The 120mg
dose achieved a 29 percentage points (ppt) delta to placebo on
HiSCR75 (p<0.001) and a 38 ppt delta to placebo on HiSCR50
(p<0.01). As early as week 8, a significant difference in
response between sonelokimab and placebo was observed across HiSCR
thresholds, including HiSCR90.
In addition, other clinically relevant secondary
endpoints also reached statistical significance at week 12 with
sonelokimab compared with placebo. This included improvements in
International Hidradenitis Suppurativa Severity Score System
(“IHS") 4, significantly greater complete resolution of draining
tunnels (DT 100) as well as significant improvements in patient
reported quality of life, skin pain, and HS symptoms.
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.
Professor Brian Kirby MD, FRCPI, Charles
Department of Dermatology, St. Vincent’s University Hospital and
Charles Institute of Dermatology, University College Dublin,
Dublin, Ireland, commented: “Hidradenitis
suppurativa is a severely debilitating chronic skin condition
resulting in irreversible tissue destruction and scarring. Patients
often suffer great pain and become socially isolated. There is an
urgent need for effective new treatments to help patients manage
their disease. The positive 12-week data presented at EADV today
with sonelokimab are highly encouraging and I look forward to
seeing further data and the start of the Phase III clinical
program.”
Kristian Reich, MD,
PhD, Founder and Chief Scientific Officer at
MoonLake, added: “We observed maximum clinical
responses of our Nanobody® sonelokimab at the lower 120mg dose
tested, demonstrating the advantage of using a smaller biologic
with albumin-binding capacity to inhibit IL-17A and IL-17F. We now
look forward to reporting the 24-week data imminently which will
provide important insights on the depth and breadth of efficacy of
sonelokimab and further data on safety.”
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. The top-line 12-week results are expected in
the first half of November 2023, ahead of the American College of
Rheumatology Conference, November 10-15.
Sonelokimab is not yet approved for use in any
indication.
- Ends –
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.
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 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 currently being assessed in two
ongoing trials, the Phase 2 MIRA trial in HS and the Phase 2 ARGO
trial in PsA. The MIRA 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. A significantly greater proportion of
patients treated with both sonelokimab 120mg and 240mg achieved
HiSCR75 compared to those on placebo at week 12. The positive
results suggest that, as early as week 12, sonelokimab, relative to
placebo, reaches the highest clinical activity among all other
therapies tested in similarly stringent pivotal-like trials. The
trial proceeds to week 24, with a 4-week safety follow-up.
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
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.
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 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 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
ICR ConsiliumMary-Jane Elliott, Namrata Taak,
Ashley TappTel: +44 (0) 20 3709
5700media@moonlaketx.comMoonLake@consilium-comms.com
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