Full Press Release Details
MoonLake Immunotherapeutics Reports
Second Quarter 2023 Financial Results and
Provides a Business Update
ZUG, Switzerland, August 10, 2023 -
MoonLake Immunotherapeutics (NASDAQ:MLTX) ("MoonLake" or the "Company"), a clinical-stage biotechnology company
focused on creating next-level therapies for inflammatory diseases, today announced its financial results for the second quarter of 2023.
MoonLake continues to make significant progress
with the clinical development of sonelokimab, which is currently being investigated in two Phase 2 clinical trials: the first, "MIRA",
in moderate-to-severe hidradenitis suppurativa (HS) and the second, "ARGO", in active psoriatic arthritis (PsA). Sonelokimab
has already been successfully assessed in a randomized, placebo-controlled, Phase 2b trial in patients with moderate-to-severe plaque-type
psoriasis, in which it demonstrated a rapid and durable skin clearance (Psoriasis Area Severity Index (PASI) 100 response). Sonelokimab
is an investigational Nanobody designed to inhibit IL-17F in addition to IL-17A and therefore could represent a major
improvement in treating inflammation in these dermatological and rheumatological diseases. The Nanobody's smaller
size versus traditional antibodies and its albumin-binding domain provide an opportunity for further efficacy. The MIRA and the ARGO trials
both achieved their target patient enrollment and randomization faster than anticipated, reflecting the Company's strong execution
and interest from physicians and patients in MoonLake's clinical development programs.
Dr. Jorge Santos da Silva, Chief Executive
Officer of MoonLake Immunotherapeutics, said: "This quarter has been transformational for MoonLake. The positive Phase 2
results from our MIRA trial were a landmark milestone. We look ahead with confidence to a number of key catalysts for sonelokimab this
year, including the final 24-week data in HS, expected in mid-October, and the topline 12-week data in active PsA, expected in the first
half of November, and to creating long-term value for both patients and shareholders."
Second Quarter 2023 Business Highlights (including
Second Quarter 2023 Financial Highlights:
Matthias Bodenstedt, Chief Financial Officer
of MoonLake Immunotherapeutics, said: "The past quarter has seen MoonLake raise significant new funds, enabling us to fund
the advancement of sonelokimab into multiple Phase 3 programs and putting us in a very strong position for the next phase of growth. We
welcome our new shareholders who recognize the value of our Nanobody and are as excited
as we are by our continued advancement of sonelokimab's clinical development to address some of the fastest growing markets in inflammatory
Important upcoming anticipated events and next
expected data readouts for MoonLake:
Calendar of upcoming investor conferences in
the second half of 2023:
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.
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.
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
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
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 the ARGO trial
The 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 also evaluates 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
Cautionary Statement Regarding Forward Looking
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, 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, clinical trials and research and development programs and the anticipated
timing of the results from those studies and trials, the timing for meeting with regulatory authorities and our anticipated cash usage
and the period of time we anticipate such cash to be available. 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