MoonLake Immunotherapeutics Announces
Positive Feedback from both FDA and EMA on Regulatory Path for the
Phase 3 Program of the Nanobody®
sonelokimab (SLK) in Hidradenitis Suppurativa
(HS)
-
Clarified path for HS Phase 3 program with study design, patient
population and endpoints agreed
-
One dose of SLK (120mg) to be tested with a similar protocol as in
Phase 2
-
Total Phase 3 population of 800 patients to be complemented by
Phase 2 population for registration
-
Phase 3 trial has similar design to validated Phase 2 trial and in
line with the Company’s communications and expectations
-
First patient expected to be randomized in Q2 2024, primary
endpoint readout expected mid-2025
-
Further details to be provided in upcoming R&D Day
ZUG, Switzerland,
February 26, 2024 – MoonLake Immunotherapeutics (NASDAQ:MLTX)
(“MoonLake”), a clinical-stage biotechnology company focused on
creating next-level therapies for inflammatory diseases, today
announced the successful outcome of its end-of-Phase 2 interactions
with the U.S. Food and Drug Administration (FDA), as well as
positive feedback from its interactions with the E.U. European
Medicines Agency (EMA), with both regulatory bodies unanimously
supporting MoonLake’s proposed approach for advancing its Phase 3
program of the Nanobody® sonelokimab (SLK) in hidradenitis
suppurativa (HS).
The Phase 3 program, named VELA, is expected to
enroll 800 patients and in combination with the data from Phase 2
MIRA trial will support both a Biologics License Application (BLA)
and E.U. Marketing Authorization Application. The Phase 3 trial
design will compare a single SLK dose (120mg) to placebo over a
16-week period, with the placebo group subsequently transitioning
to SLK 120mg. The primary endpoint (HiSCR75) and key secondary
endpoints read out at week 16. The VELA trial program is designed
to run for 52 weeks followed by an open-label extension (OLE).
The number of patients, the straightforward trial design,
the similarity of protocol to the Phase 2 trial, and
the identification of the HS dose, collectively, enhance
the clarity of SLK’s clinical
development and displays promise for the HS
franchise. The readout of the primary endpoint is anticipated in
mid-2025.
Dr. Jorge Santos da Silva, Chief
Executive Officer of MoonLake Immunotherapeutics, said:
“The favorable response from both the FDA and EMA aligns with the
strengths we have consistently highlighted in our trial programs
and outlines a clear regulatory path for sonelokimab in
hidradenitis suppurativa. We deeply appreciate the support from
both agencies and continue to work swiftly to ramp up the Phase 3
program in HS, named VELA. This represents a crucial step in
offering a potential innovative treatment option to patients and
their dedicated physicians, addressing a condition that is often
under-recognized, under-treated and significantly impacts patients’
lives.”
Additionally, MoonLake plans to have an
end-of-Phase 2 meeting with the FDA regarding its psoriatic
arthritis (PsA) program in Q2 2024 and begin the Phase 3 program in
Q4 2024.
Moonlake will provide more information relating
to the plans for both the HS and PsA programs during an upcoming
R&D Day.
- 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
on 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 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 ( the Investigator’s Global Assessment
Score 0 or 1, and the 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).
Sonelokimab is not yet approved for use in any
indication.
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: anticipated support from regulatory agencies with
respect to the Company’s development plans, anticipated size and
timing of enrollment for the VELA trial, the sufficiency of data
from the VELA trial to support regulatory filings in the US and EU,
the anticipated trial design for the VELA trial and the timing of
expected readouts, 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, and the Company’s
plans with respect to FDA meetings for its PsA program and the
commencement of a Phase 3 trial in PsA. 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, unknown future interactions with
regulatory agencies, 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.
CONTACT:MoonLake Immunotherapeutics
Investors
Matthias Bodenstedt, CFOir@moonlaketx.com
MoonLake Immunotherapeutics Media
Patricia Sousa, Director Corporate
Affairsmedia@moonlaketx.com
ICR ConsiliumMary-Jane Elliott,
Ashley Tapp, Namrata Taak
Tel: +44 (0) 20 3709
5700media@moonlaketx.comMoonLake@consilium-comms.com
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