MoonLake Immunotherapeutics to present
MIRA trial data of Nanobody®
sonelokimab in hidradenitis suppurativa as a late breaker
at the AAD Annual Meeting 2024
ZUG, Switzerland, March 4,
2024 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a
clinical-stage biotechnology company focused on creating next-level
therapies for inflammatory diseases, today announced that 24-week
data from its Phase 2 MIRA trial with the Nanobody sonelokimab in
moderate to severe hidradenitis suppurativa (HS), will be presented
in a late breaking oral session on March 10 at 14:00 PST at the
2024 American Academy of Dermatology (AAD) Annual Meeting, taking
place from March 8-12, in San Diego, California.
Kristian Reich, MD, PhD, Chief
Scientific Officer at MoonLake commented: “We are
pleased that the 24-week data from our Phase 2 MIRA trial has been
selected by the American Academy of Dermatology as an oral
late-breaking presentation. Hidradenitis suppurativa is a severely
debilitating chronic skin condition and the data will showcase the
therapeutic effect of maintenance treatment with our Nanobody®
sonelokimab.”
The oral presentation titled “Efficacy and
safety of the IL-17A- and IL-17F-inhibiting Nanobody® sonelokimab
in patients with moderate-to-severe hidradenitis suppurativa (HS):
Week 24 results from the Phase 2 MIRA trial” will be presented by
Professor Brian Kirby MD, FRCPI, Department of Dermatology, St.
Vincent’s University Hospital and Charles Institute of Dermatology,
University College Dublin, Dublin, Ireland. The presentation will
be held on Sunday 10 March at 14:00 PST / 17:00 EST / 23:00 CET
during the late breaking research session 2 (S050) in room 20B.
Key members of the MoonLake team, including the
executive leadership team, will attend AAD. In June 2023, MoonLake
announced that the MIRA trial achieved a landmark milestone with
positive top-line 12-week data using HiSCR75 as the primary
endpoint and later presented the data at a late-breaking session at
the European Academy of Dermatology and Venereology Congress in
October. This was followed by an announcement in October 2023,
reporting from the trial at 24 weeks, further establishing
sonelokimab as a highly promising and differentiated therapeutic
solution for HS.Sonelokimab is not yet approved for use in any
indication.
– Ends –
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 is being assessed in two trials, the
Phase 2 ARGO trial in PsA 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.
In November 2023, MoonLake 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 trial 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. All key secondary endpoints in the
trial were met for the 60mg and 120mg doses with induction.
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 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 .
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
patient enrollment in the MIRA and ARGO trials, 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, and our anticipated cash usage and the period of time we
anticipate such cash to be available. 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.
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
5700MoonLake@consilium-comms.com
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