MoonLake Immunotherapeutics starts Phase
2 trial of the Nanobody®
Sonelokimab in patients with moderate-to-severe
hidradenitis suppurativa
- First Phase 2
trial in hidradenitis suppurativa using the higher clinical
response level of HiSCR75 as the primary endpoint
- Trial evaluates
sonelokimab, an investigational Nanobody® with an innovative mode
of action designed to treat and elevate patient outcomes for
inflammatory disease
ZUG, Switzerland, May 12, 2022
– MoonLake Immunotherapeutics AG (MoonLake; Nasdaq: MLTX), a
clinical-stage biotechnology company focused on creating next-level
therapies for inflammatory diseases, today announced that the first
patient has been randomized and dosed, in a U.S. site, in its
global Phase 2 clinical trial evaluating sonelokimab, an
investigational Nanobody® designed to treat inflammatory disease,
in patients with moderate-to-severe hidradenitis suppurativa
(HS).
HS is a severely debilitating chronic skin
condition, with a prevalence of approximately 1% globally, that
results in irreversible tissue destruction. Sonelokimab (M1095)
inhibits the naturally occurring IL-17A/A, IL-17A/F, and IL-17F/F
dimers that drive inflammation. In addition, sonelokimab is
designed to directly target sites of inflammation and penetrate
difficult-to-reach inflamed tissues.
The MIRA trial (M1095-HS-201) is a global,
randomized, double-blind, placebo-controlled trial to evaluate the
efficacy and safety of different doses of sonelokimab, compared
with placebo, with adalimumab as an active control reference arm,
in over 200 patients with HS.
This trial represents a landmark milestone in HS
clinical development as it is the first to use Hidradenitis
Suppurativa Clinical Response (HiSCR) 75 as its primary endpoint.
HiSCR75 is 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. Using an at least 75%
improvement of HiSCR as the primary endpoint reflects
MoonLake’s goal to revolutionize patient outcomes by seeking a
greater reduction in disease markers than is typically tested in
clinical trials.
The trial will also include a range of secondary
endpoints reflecting the heterogeneous clinical phenotypes of the
disease, including inflammatory lesions and tunnels, as well as a
number of patient-reported outcome measures such as pain and
quality of life assessments. The first sites of this global trial
have been initiated in the United States.
Kristian Reich, Founder and Chief
Scientific Officer at MoonLake, commented: “There remains an urgent
need for novel treatments for hidradenitis suppurativa, a
devastating skin disease that impacts approximately 1% of people
globally. The commencement of our Phase 2 trial with sonelokimab is
a landmark moment for HS as it is the first to use an endpoint that
aims for a higher clinical response level. We believe that
sonelokimab has the potential to elevate patient outcomes due to
its ability to inhibit the naturally occurring IL-17A/A, IL-17A/F,
and IL-17F/F dimers that drive inflammation in HS, and its
Nanobody® characteristics should improve its tissue penetration,
helping the molecule to target difficult-to-reach inflammatory
lesions such as deep abscesses and tunnels.”
The initiation of this Phase 2 trial follows the
announcement in March 2022 that approval of trial protocol was
obtained from the central Institutional Review Board as part of
MoonLake’s Investigational New Drug (IND) filing with the U.S. Food
and Drug Administration. The trial is expected to complete by the
end of 2023.
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 will
comprise over 200 patients, and will evaluate two different doses
of sonelokimab, with placebo control and adalimumab as an active
control 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
will also evaluate 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 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 naturally occurring
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, psoriatic arthritis, and
ankylosing spondylitis (also known as radiographic axial
spondyloarthritis), 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 the ability to design
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 naturally occurring 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 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). Sonelokimab is not yet
approved for use in any indication.
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 anticipated
markets for products, if approved. 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 Current
Report on Form 8-K filed on April 11, 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
MediaMatthew Cole, Mary-Jane ElliottConsilium Strategic
CommunicationsTel: +44 (0) 20 3709
5700media@moonlaketx.comMoonLake@consilium-comms.com
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