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 Suppurativ

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)

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).

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."

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

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.

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

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.

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.

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.

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."

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."

topline data will be discussed on 16 October 2023 at 2pm CEST/ 8am EDT before the Nasdaq market opens, via webcast at:

Link: (for those already registered)

replay of the webcast and the presentation document will be made available at https://ir.moonlaketx.com.

results from the MIRA trial will be submitted for publication in a peer-reviewed medical journal and for presentation at an upcoming

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.

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.

is not yet approved for use in any indication.

Hidradenitis Suppurativa

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

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.

(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.

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.

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).

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).

MoonLake Immunotherapeutics

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