MoonLake completes patient randomization ahead
of schedule for its
Phase 2 trial in active psoriatic arthritis (PsA) and provides
calendar of next readouts
- Randomization target of 200 patients completed ahead of
schedule in the ARGO PsA trial
- Top-line 12-week results of the ARGO trial in PsA for the novel
IL-17A and IL-17F inhibiting Nanobody® sonelokimab, are now
expected in the first half of November 2023, ahead of the American
College of Rheumatology Conference, November 10-15th
- A Capital Markets Day will be held on September 11th 2023 to
discuss the PsA market and share expectations on the ARGO readout
and an update on the MIRA trial in Hidradenitis Suppurativa (HS)
top-line 24-week data readout, now expected in mid-October 2023,
following the recent successful top-line 12-week data readout
- The Company also announces a calendar of upcoming events and
data readouts
ZUG, Switzerland, July 25, 2023
– MoonLake Immunotherapeutics AG (“MoonLake”; Nasdaq: MLTX), a
clinical-stage biotechnology company focused on creating next-level
therapies for inflammatory diseases, today announced that it has
successfully completed randomization of the target 200 patients,
several weeks ahead of schedule, in its global Phase 2 ARGO
clinical trial evaluating Nanobody® sonelokimab in active psoriatic
arthritis (PsA).
MoonLake also announced a Capital Markets Day to
be held in New York at NASDAQ, including a virtual webcast format,
on September 11th 2023. This session will be used to discuss
the PsA market and share expectations on the top-line 12-week ARGO
data readout, as well as an update on the MIRA trial in
Hidradenitis Suppurativa (HS) 24-week data readout, expected in
mid-October 2023, following the successful top-line 12-week data
readout.
Jorge Santos da Silva, PhD, Founder and
Chief Executive Officer at MoonLake, said: “ARGO is
MoonLake’s second trial to have achieved faster completion of
recruitment and randomization than expected. Reaching this stage
well ahead of schedule for active psoriatic arthritis is an
encouraging reflection of the interest in our clinical development
programs. We are looking forward to all of the upcoming key
MoonLake readouts and events and are excited about updating
investors with our progress in due course.”
The ARGO trial in PsAThe ARGO
trial (NCT05640245) commenced patient screening in December 2022
with the aim to evaluate the clinical efficacy and safety of
Nanobody® sonelokimab at 120mg and 60mg dosed every 4 weeks (after
bi-weekly induction dosing) and 60mg dosed every 4 weeks (with no
induction dosing) compared with placebo. The trial also includes
adalimumab, the current standard of care for PsA, as an active
reference arm. The purpose of including this arm, which is not
statistically powered, was to validate the study and to guide the
design of the Phase 3 trial.
PsA is a complex, chronic and progressive
inflammatory disease. The clinical features of PsA are diverse,
comprising both musculoskeletal (such as enthesitis, a type of
inflammation of the joints) and non-musculoskeletal (skin and nail
psoriasis) manifestations. Patient burden is high with many
patients presenting with more than one clinical manifestation. Both
IL-17F and IL-17A are implicated in disease pathophysiology and
inhibition shows promise for patients and their treating physicians
in concurrently elevating treatment outcomes for joint and skin
inflammation.
Sonelokimab (M1095) is an investigational
Nanobody® designed to inhibit IL-17F in addition to IL-17A and
therefore could potentially represent a major improvement in
treating PsA. The Nanobody’s® smaller size versus traditional
antibodies and albumin-binding domain provide an opportunity for
further efficacy as determined by American College of Rheumatology
(ACR)50 and Psoriasis Area and Severity Index (PASI)90. These and
other clinically relevant endpoints are being tested in the ARGO
trial.
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.
Kristian Reich, Founder and Chief
Scientific Officer at MoonLake, commented: “We are looking
forward to announcing top-line data from the psoriatic arthritis
trial ahead of the American College of Rheumatology meeting this
year and hope to demonstrate elevation of treatment outcomes across
various facets of this complex and debilitating disease. Our
programs aim to develop an improved treatment option for patients
with chronic inflammatory diseases. Considering the type of
inflammation in PsA with involvement of penetration-sensitive
tissues, such as the peripheral and spinal entheses, we consider
our IL-17A and F inhibiting Nanobody® sonelokimab a promising
potential therapeutic option, both from a mode of action as well as
from a molecule perspective. PsA patients also have psoriasis and
our Nanobody® has previously shown leading clinical activity in
reaching complete skin clearance with a favorable benefit-risk
profile.”
Status update on the MIRA trial in HS
In February 2023, the Phase 2 MIRA trial
(NCT05322473) of the Nanobody® sonelokimab in
moderate-to-severe hidradenitis suppurativa (HS) completed its
target enrollment ahead of schedule (to a total of 234 patients).
Following this, in June 2023, MoonLake announced positive top-line
results from the trial which met its primary endpoint with a
significantly greater proportion of patients treated with both
sonelokimab 120mg and 240mg achieving HiSCR75 compared to those on
placebo at week 12. The 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. Further data on the trial can be
found online in the press release here and in the R&D Day
presentation and webcast on our website here.
The trial continues beyond week 12, and week 24
results (including a subsequent 4-week safety follow-up period)
will be available in mid-October 2023. These will include data on
the additional duration of response across all endpoints,
improvement of response over time with maintenance dosing, as well
as additional information on dose selection for Phase 3. An
update on the top-line 24-week data readout from the MIRA trial in
Hidradenitis Suppurativa (HS) will be discussed at the September
2023 Capital Markets Day, including sharing expectations on the
results.
Important upcoming events and next data readouts for
MoonLake: September:
- Capital Markets Day in New York in person at NASDAQ, and
virtually via webcast, on September 11th from 11:30 am – 13:00pm
EDT/17:30 – 19:00 pm CEST to discuss the PsA market and
expectations ahead of the top-line 12-week results for the ARGO
trial and an update on the 24-week data readout from the MIRA trial
in Hidradenitis Suppurativa (HS), now expected in mid-October
2023
October:
- MIRA trial top-line 12-week data will be presented at a
scientific meeting
- R&D Day virtual webcast in mid-October 2023, where the
top-line 24-week data of the MIRA trial will be first unveiled,
together with Phase 3 trial plans in HS
November:
- R&D Day virtual webcast in early November, ahead of the
American College of Rheumatology (ACR) Conference where top-line
results for the PsA ARGO trial will be first presented
December:
- End of Phase 2 meeting with the FDA is expected in mid-December
2023, to discuss Phase 2 HS data and define plan for Phase 3
clinical trial final designs and clinical operations
Early 2024:
- R&D Day to communicate the final Phase 3 plans as well as
other clinical and business catalysts in 2024 and beyond
Sonelokimab is not yet approved for use in any
indication.
- ends -
About the ARGO trialThe ARGO
trial (M1095-PSA-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 PsA. The trial is designed
to evaluate 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 ≥50%
improvement in signs and symptoms of disease from baseline,
compared to placebo, as measured by the American College of
Rheumatology (ACR) 50 response. The trial will also evaluate a
number of secondary endpoints, including improvement compared to
placebo in ACR70, complete skin clearance as measured by at least a
100% improvement in the Psoriasis Area and Severity Index, physical
function as measured by the Health Assessment
Questionnaire-Disability Index, enthesitis as measured by the Leeds
Enthesitis Index and pain as measured by the Patients Assessment of
Arthritis Pain. Further details are available on:
https://clinicaltrials.gov/ct2/show/NCT05640245
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 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.
On June 25th 2023, MoonLake announced positive
top-line results from the Phase 2 MIRA trial in HS, which met its
primary endpoint with a significantly greater proportion of
patients treated with both sonelokimab 120mg and 240mg achieving
HiSCR75 compared to those on placebo at week 12.
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
(announced on Dec 14, 2022).
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic and
progressive inflammatory arthritis associated with psoriasis
primarily affecting the peripheral joints. The clinical features of
PsA are diverse, involving pain, swelling, and stiffness of the
joints, which can result in restricted mobility and
fatigue. PsA occurs in up to 30% of patients with psoriasis,
most commonly those aged between 30 and 60 years. The symptom
burden of PsA can have a substantial negative impact on patient
quality of life. Although the exact mechanism of disease is not
fully understood, evidence suggests that activation of the IL-17
pathway plays an important role in the disease
pathophysiology.
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) 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 top-line data from
the ARGO 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 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.
Contacts:
MoonLake Immunotherapeutics Investors Matthias
Bodenstedt, CFO info@moonlaketx.com
MoonLake Immunotherapeutics Media
Patricia Sousa media@moonlaketx.com
Consilium Strategic Communications Mary-Jane
Elliott, Ashley Tapp, Namrata TaakTel: +44 (0) 20 3709
5700media@moonlaketx.com MoonLake@consilium-comms.com
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