MoonLake Immunotherapeutics presents positive 12-week data from the

Phase 2 MIRA trial with Nanobody® Sonelokimab for Hidradenitis Suppurativa at the European Academy of Dermatology and Venereology Congress

• Peer reviewed data presented during a late-breaking session at the European Academy of Dermatology and Venereology Congress (EADV) confirms the strong profile of sonelokimab in HS announced at MLTX's R&D Day on June 26, 2023
• HiSCR75 primary endpoint met with a significantly higher proportion of patients on sonelokimab 120mg (43.3%) compared to placebo (14.7%) achieving HiSCR75 at week 12; a 29 percentage points (ppt) delta (p<0.001)
• HiSCR50 secondary endpoint met with a significantly higher proportion of patients on sonelokimab 120mg (65.7%) compared to placebo (27.9%) achieving HiSCR50 at week 12; a 38 ppt delta (p<0.001)
• Sonelokimab rapidly achieved high levels of response across HiSCR thresholds, including HiSCR 90 and IHS4, and significant resolution of draining tunnels (DT 100) compared to placebo
• Sonelokimab also led to significant improvements in patient-reported quality of life, skin pain, and HS symptoms compared with placebo, with additional depth of response reported following additional analysis after the June R&D Day
• Safety results of sonelokimab were consistent with previously reported studies with no new observed signals, and included additional insight following further analysis after the June R&D Day
• 24-week data from the Phase 2 MIRA trial is anticipated imminently
  
  
  
   

ZUG, Switzerland, October 11, 2023 – MoonLake Immunotherapeutics (("MoonLake", NASDAQ:MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, announced that positive 12-week results from its global Phase 2 MIRA trial evaluating the efficacy and safety of the Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa ("HS") were presented today during a late-breaking session at the European Academy of Dermatology and Venereology Congress ("EADV") held in Berlin, Germany.

The EADV presentation follows the announcement, in June 2023, of the positive topline

12-week results from the trial in 234 patients, which marked a landmark milestone as the first placebo-controlled randomized trial in HS to report results using HiSCR75 as the primary endpoint. The primary analysis was based on the most stringent type of analysis for such trials, intent-to-treat non-responder imputation ("ITT-NRI").

The MIRA trial met its primary endpoint with a significantly higher proportion of patients treated with both sonelokimab 120mg (43.3%) and 240mg (34.8%) achieving HiSCR75 compared to those on placebo (14.7%) at week 12. Sonelokimab also met the key secondary endpoint with a significantly higher proportion of patients treated with both sonelokimab 120mg (65.7%) and 240mg (53.0%) achieving HiSCR50 compared to those on placebo (27.9%) at week 12. Both doses performed similarly, with the 120mg dose providing the highest delta on HiSCR75 and HiSCR50. The 120mg dose achieved a 29 percentage points (ppt) delta to placebo on HiSCR75 (p<0.001) and a 38 ppt delta to placebo on HiSCR50 (p<0.01). As early as week 8, a significant difference in response between sonelokimab and placebo was observed across HiSCR thresholds, including HiSCR90.

In addition, other clinically relevant secondary endpoints also reached statistical significance at week 12 with sonelokimab compared with placebo. This included improvements in International Hidradenitis Suppurativa Severity Score System ("IHS") 4, significantly greater complete resolution of draining tunnels (DT 100) as well as significant improvements in patient reported quality of life, skin pain, and HS symptoms.

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.

Professor Brian Kirby MD, FRCPI, Charles Department of Dermatology, St. Vincent's University Hospital and Charles Institute of Dermatology, University College Dublin, Dublin, Ireland, commented: "Hidradenitis suppurativa is a severely debilitating chronic skin condition resulting in irreversible tissue destruction and scarring. Patients often suffer great pain and become socially isolated. There is an urgent need for effective new treatments to help patients manage their disease. The positive 12-week data presented at EADV today with sonelokimab are highly encouraging and I look forward to seeing further data and the start of the Phase III clinical program."

Kristian Reich, MD, PhD, Founder and Chief Scientific Officer at MoonLake, added: "We observed maximum clinical responses of our Nanobody® sonelokimab at the lower 120mg dose tested, demonstrating the advantage of using a smaller biologic with albumin-binding capacity to inhibit IL-17A and IL-17F. We now look forward to reporting the 24-week data imminently which will provide important insights on the depth and breadth of efficacy of sonelokimab and further data on safety."

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 being evaluated in a Phase 2 trial (NCT05640245), ‘ARGO', in patients with active psoriatic arthritis. The top-line 12-week results are expected in the first half of November 2023, ahead of the American College of Rheumatology Conference, November 10-15.

Sonelokimab is not yet approved for use in any indication.