MoonLake Immunotherapeutics announces the
full dataset from its 24-week MIRA clinical trial, establishing the
Nanobody® sonelokimab as a highly
promising and differentiated therapeutic solution for Hidradenitis
Suppurativa (HS)
- Maintenance
treatment with sonelokimab dosed every 4 weeks (Q4W), demonstrated
that 57% of patients achieved HiSCR75 at week 24, increasing the
landmark week 12 responses (primary endpoint) by over 10 ppt
(percentage points)
- The depth of
responses continued to increase from week 12 to week 24 across
several scores, including over 14 ppt increases in HiSCR90 and
IHS4-90 (to approximately 40% of patients) – 1 in every 4 patients
reached inflammatory remission with IHS4-100, reflecting 100%
reduction in abscesses, nodules and draining tunnels
- Rates of
complete resolution of inflammatory nodules and abscesses (AN 100)
and draining tunnels (DT 100) increased between week 12 and 24
- Clinical
responses translated to robust improvements in health related
quality of life (DLQI), skin pain (NRS30), and self-reported absent
or minimal disease (PGI-S)
- Maintenance
dosing, placebo cross-overs to sonelokimab 120mg or 240mg, as well
as pharmacokinetic data, confirm 120mg as the dose with optimal
benefit-risk profile
- For
non-responders to adalimumab at week 12 switching to sonelokimab
resulted in HiSCR75 response rates similar to those randomized to
sonelokimab at baseline
- Safety results
of sonelokimab were consistent with previously reported studies
with no new observed safety signals
- Topline data
will be discussed on 16 October, at 2pm CEST/ 8am
EDT, via webcast (registration link below)
ZUG, Switzerland, October
15 2023 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a
clinical-stage biotechnology company focused on creating next-level
therapies for inflammatory diseases, today announced positive
24-week top-line results from its global Phase 2 MIRA trial showing
that maintenance treatment with its Nanobody® sonelokimab led
to further improvements in HiSCR75 response rates and other
clinically relevant outcomes in patients with moderate-to-severe
hidradenitis suppurativa (HS).
Jorge Santos da Silva, PhD, Founder
and Chief Executive Officer at MoonLake,
said: “The overall data package created with the MIRA
trial establishes MoonLake’s position as a leading innovator in the
Immunology and Inflammation (I&I) and IL-17 space. We have
consistently observed best-in-class clinical activity with our
Nanobody® sonelokimab for hidradenitis suppurativa and these
results demonstrate its effect on a number of clinically meaningful
endpoints. In June we elevated the bar for clinical response to
HiSCR75 as the primary endpoint. We have now advanced to
demonstrating even deeper responses (such as HiSCR90, AN 100 and DT
100) and on scores that are important for patients, such as
complete inflammatory remission with IHS4-100 and absent or minimal
disease activity as reported by patients (PGI-S). Importantly, the
results have confirmed our view that 120mg is the optimal dose and
we are on track to discuss our Phase 3 development plans with the
FDA by the end of this year.”
The 24-week results follow the positive 12-week
results, announced in June 2023 and subsequently presented at the
European Academy of Dermatology and Venereology Congress in October
2023, in which the primary endpoint was met with 29 percentage
points delta versus placebo (p=0.0002) at week 12. The MIRA trial
set a landmark milestone as the first placebo-controlled randomized
trial in HS to use Hidradenitis Suppurative Clinical Response 75
(HiSCR75) as the primary endpoint.
The 24-week results show that ongoing treatment
with sonelokimab 120mg and 240mg dosed Q4W, further increased
HiSCR75 response rates compared to week 12. 57% of patients
continuously treated with 120mg achieved a HiSCR75 response (more
than 10 ppt improvement from Week 12) and 38% achieved HiSCR90
(more than 14ppt improvement versus week 12). The IHS4 score, which
encompasses changes in all active HS lesions (nodules, abscesses,
draining tunnels), decreased by 65% in patients treated with the
120mg maintenance dose.
Rates of complete resolution of inflammatory
nodules and abscesses (AN 100) together with complete resolution of
draining tunnels (DT 100) also increased between week 12 and 24
(31% and 49% of patients achieving this high level of response at
week 24 with 120mg respectively, an increase of up to 15 ppt).
Complete inflammatory remission (IHS4-100) was achieved in 1 in 4
patients (24%) treated with 120mg at week 24. Clinical responses
translated to profound improvements in patient-reported outcomes at
24 weeks including quality of life (DLQI), pain (NRS30), and
patient global impression of severity. 43% of patients reached
self-reported absent or minimal disease activity on the PGI-S
scale.
Results obtained with placebo patients
re-randomized to sonelokimab 120mg or 240mg in Part B, after the
primary analysis, replicated the dose responses observed in Part A.
Difficult-to-treat subgroup analysis (e.g., in Hurley stage III
patients or those previously exposed to biologics) confirms the
advantage of the 120mg dose. Similarly, pharmacokinetics (PK)
analysis support the use of the monthly maintenance 120mg dose. For
patients who were inadequate responders to adalimumab at week 12
switching to sonelokimab resulted in HiSCR75 response rates similar
to responses in those randomized to sonelokimab at baseline.
Sonelokimab provided better durability of response compared to that
observed with adalimumab in other studies.
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.
Based on the efficacy and safety results, Q4W
maintenance dosing of sonelokimab 120mg has been confirmed in the
Company’s view as the optimal dose, in terms of speed and depth of
response, and overall benefit-risk profile, for progression into
Phase 3 development.
Kristian Reich, MD,
PhD, Founder and Chief Scientific Officer at
MoonLake, commented: “These positive results at
24 weeks, which build upon the initial 12-week results, show that
the clinical activity and responses with longer exposure of
sonelokimab deepen over time in patients with hidradenitis
suppurativa as we saw in psoriasis. It underscores the advantage of
treating patients with a smaller biologic with albumin-binding
capacity to inhibit IL-17A and IL-17F for the treatment of
inflammatory diseases and highlights the impact our Nanobody®
sonelokimab has on a breadth of outcomes that matter for patients
with HS, beyond HiSCR75. MIRA creates, in my opinion, a unique
Phase 2 data package, for a disease that has proven to be extremely
challenging to treat.”
Joslyn Kirby, MD, MEd, MS, Professor and
Vice Chair for Education, Department of Dermatology at Penn State,
and President of the Hidradenitis Suppurativa Foundation
added: “Hidradenitis suppurativa is a chronic,
inflammatory condition that has profound impacts on a patients'
lives. As a clinician who works with people with HS, there is an
urgent need for new treatment options that give patients high
levels of response and meaningful improvements in their condition.
The high clinical response rates observed with sonelokimab in the
Phase 2 MIRA trial, which are accompanied by critical improvements
in patient reported outcomes, are exciting, demonstrating its
promise as a potential future treatment option.”
These topline data will be discussed on
16 October 2023 at 2pm CEST/ 8am EDT before the Nasdaq
market opens, via webcast at:
Registration
Link:https://onlinexperiences.com/Launch/QReg/ShowUUID=172DFCAF-36D9-4C44-BF2C-982C999BE61F&LangLocaleID=1033&GroupID=Onyx
Login Link: (for those already
registered)https://onlinexperiences.com/Launch/Event/ShowKey=241209
A replay of the webcast and the presentation
document will be made available
at https://ir.moonlaketx.com.
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 also being evaluated in
a Phase 2 trial (NCT05640245), ‘ARGO’, in patients with active
psoriatic arthritis with the primary end-point readout expected in
early November this year.
Sonelokimab is not yet approved for use in any
indication.
- Ends –
About Hidradenitis
SuppurativaHidradenitis 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 trialThe 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 SonelokimabSonelokimab (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. In June 2023, 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. Following the
positive 12-week results, positive results at 24 weeks have now
been announced in October 2023.
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 MoonLake
ImmunotherapeuticsMoonLake 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.
Cautionary Statement Regarding Forward
Looking StatementsThis 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 commencing a phase
3 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 Consilium Mary-Jane Elliott, Namrata Taak,
Ashley TappTel: +44 (0) 20 3709
5700media@moonlaketx.comMoonLake@consilium-comms.com
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