Phase 2 MIRA primary analysis trial
results (12-week) for MoonLake’s
Nanobody® sonelokimab in
hidradenitis suppurativa to be presented at a late-breaking session
at the European Academy of Dermatology and Venereology
Congress
ZUG, Switzerland, October 4,
2023 – MoonLake Immunotherapeutics AG (“MoonLake”; Nasdaq: MLTX), a
clinical-stage biotechnology company focused on creating next-level
therapies for inflammatory diseases, today announces that 12-week
Phase 2 MIRA trial data for the Nanobody® sonelokimab in
hidradenitis suppurativa will be presented at the European Academy
of Dermatology and Venereology Congress taking place from October
11-14 in Berlin, Germany.
In June 2023, MoonLake
announced positive topline 12-week Phase 2 MIRA trial results,
achieving a landmark milestone as the first placebo-controlled
randomized trial in HS to report positive top-line results using
HiSCR75 as the primary endpoint.
Professor Brian Kirby MD, FRCPI, Charles
Department of Dermatology, St. Vincent’s University Hospital and
Charles Institute of Dermatology, University College Dublin,
Dublin, Ireland will be presenting the results in a late-breaking
news presentation, details of which are included below.
Session code and title:
D1T01.1: Late breaking newsLocation: Hall
BDate and time: Wednesday, 11
October; session 14.15 - 17.30 CEST, presentation
16.15 - 16.30 CESTPresentation title: Efficacy and
safety of the IL-17A- and IL-17F-inhibiting Nanobody® sonelokimab
in patients with active, moderate-to-severe hidradenitis
suppurativa: Results from the global, randomized, double-blind,
placebo-controlled Phase 2 MIRA trial
The 24-week Phase 2 MIRA trial data for
Nanobody® sonelokimab in hidradenitis suppurativa is anticipated
imminently.
In addition, top-line 12-week results for
MoonLake’s Phase 2 ARGO trial with Nanobody® sonelokimab in
psoriatic arthritis (PsA) are expected in the first half of
November 2023, ahead of the American College of Rheumatology
Conference, November 10-15.
- 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 HS. The trial recruited 234 patients, with the
aim to evaluate two 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
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 evaluates 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 on:
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 also been assessed in a
randomized, placebo-controlled Phase 2b trial 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 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). Recently, a global phase 2
trial in psoriatic arthritis (NCT05640245, M1095-PSA-201, “ARGO”)
including multiple arms and over 200 patients has been
initiated.
Sonelokimab is not yet approved for use in any
indication.
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 the ability to design
multivalent therapeutic molecules with bespoke target
combinations.
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 and timing of clinical trials, including
expectations regarding the timing and outcome of the MIRA and ARGO
trials, and clinical trials and the anticipated timing of the
results from those 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 regarding the timing and outcome of the
MIRA and ARGO trials; positive results from a clinical trial may
not necessarily be predictive of the results of future or ongoing
clinical studies; 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 Consilium Mary-Jane
Elliott, Ashley Tapp, Namrata TaakTel: +44 (0) 20 3709
5700media@moonlaketx.comMoonLake@consilium-comms.com
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