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

MoonLake Immunotherapeutics, a clinical-stage biotechnology company, has announced the full dataset from its 24-week MIRA clinical trial, showcasing the potential of its Nanobody® sonelokimab as a highly promising therapeutic solution for Hidradenitis Suppurativa (HS). The trial demonstrated that maintenance treatment with sonelokimab led to further improvements in HiSCR75 response rates and other clinically relevant outcomes in patients with moderate-to-severe HS.

The MIRA trial, a global Phase 2 study, set a 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 showed that ongoing treatment with sonelokimab led to increased HiSCR75 response rates compared to week 12. Notably, 57% of patients continuously treated with 120mg achieved a HiSCR75 response, and 38% achieved HiSCR90. The trial also demonstrated significant improvements in other measures, such as complete inflammatory remission and minimal disease activity.

MoonLake’s Nanobody® sonelokimab has consistently shown best-in-class clinical activity for HS, and these results further validate its effectiveness. The data confirmed that the 120mg dose is the optimal dose, and MoonLake plans to discuss its Phase 3 development plans with the FDA by the end of the year.

The positive results at 24 weeks build upon the initial 12-week results, highlighting the deepening clinical activity and responses with longer exposure to sonelokimab. The trial showcased the impact of sonelokimab on a range of outcomes that matter for patients with HS, beyond HiSCR75. This data package is unique and significant for a disease that has proven challenging to treat.

Hidradenitis suppurativa is a severely debilitating chronic skin condition that affects a significant portion of the global population. It causes painful inflammatory skin lesions, leading to irreversible tissue destruction and scarring. MoonLake’s sonelokimab targets IL-17A and IL-17F, which play a key role in the pathogenesis of HS.

The positive results from the MIRA trial offer hope for patients suffering from HS, as current treatment options are limited. MoonLake’s Nanobody® sonelokimab has the potential to provide high levels of response and meaningful improvements in the condition, addressing the urgent need for new treatment options.

MoonLake Immunotherapeutics is focused on developing innovative therapies for inflammatory diseases. Sonelokimab has already shown promising results in a Phase 2b trial for moderate-to-severe plaque-type psoriasis, demonstrating rapid and durable skin clearance. The company is also evaluating sonelokimab in a Phase 2 trial for psoriatic arthritis.

The full results from the MIRA trial will be submitted for publication in a peer-reviewed medical journal and presented at an upcoming scientific meeting. MoonLake’s commitment to advancing the treatment options for HS and other inflammatory diseases highlights its dedication to improving patients’ lives.

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