MoonLake Immunotherapeutics

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MoonLake Immunotherapeutics is a clinical-stage biotechnology company focused on advancing Sonelokimab (SLK), an investigational tri-specific nanobody therapy for inflammatory diseases.

SLK is a ~40kDa humanized nanobody consisting of three domains that binds interleukin-17A (IL-17A), IL-17F, and human serum albumin. It has a unique mechanism of action that inhibits the inflammatory cytokines IL-17A and IL-17F, which are implicated in several autoimmune and inflammatory diseases. Unlike other IL-17 inhibitors, SLK can block all IL-17 pro-inflammatory dimers (IL-17A/A, IL-17A/F, and IL-17F/F). Its small size also enables tissue penetration. SLK is administered subcutaneously once every four weeks.

MoonLake has tested SLK across phase 2 trials in hidradenitis suppurativa (HS), psoriatic arthritis (PsA), and psoriasis (PsO), demonstrating leading clinical efficacy and a favorable safety profile. This positions SLK as a potentially best-in-class IL-17 inhibitor.

The phase 2b MIRA trial evaluated SLK in 234 patients with moderate-to-severe HS. At 12 weeks, SLK met the primary endpoint by significantly exceeding the HiSCR75 response rate compared to placebo, demonstrating the highest HiSCR75 seen for any HS drug. SLK also showed greater depth of response versus competitors on HiSCR90, IHS4, and draining tunnel endpoints.

The trial had a robust pivotal-like design with placebo control, two doses, mandatory background antiseptic treatment, and minimal discontinuations. This gives confidence that the Phase 2 results can be replicated in Phase 3. At 24 weeks, monthly SLK dosing further increased response rates across all endpoints. Over 40% of patients reached HiSCR90 and about 25% achieved complete inflammatory remission. The 120mg dose was confirmed as optimal. These results position SLK to transform outcomes in HS.

In 207 PsA patients, SLK met the primary endpoint by significantly exceeding placebo on ACR50 at 12 weeks. It demonstrated the highest ACR50 seen for any IL-17 drug at this time-point. SLK also showed high PASI90/PASI100 skin clearance rates. Notably, SLK helped over 30% of patients achieve the ambitious treatment targets of both ACR50 and PASI100 simultaneously. Over 40% reached ACR50+PASI90. These leading multi-domain response rates set SLK apart from other PsA drugs.

SLK also enabled high rates of Minimal Disease Activity and Psoriasis Area and Severity Index 100 responses, reflecting its ability to drive deep joint and skin responses. Responses appeared to increase further by week 16, especially for the 120mg dose.

In 313 PsO patients, SLK showed superiority to the IL-17A inhibitor Cosentyx on the primary endpoint of PASI100 response at 12 weeks. SLK demonstrated 56% higher PASI100 rates, reflecting the added benefit of dual IL-17A/F inhibition.

SLK also maintained clinical response and molecular remission over time, even after withdrawal. This indicates a long-lasting anti-inflammatory effect that further differentiates SLK.

Across trials, SLK demonstrated rapid onset of response, depth of response, convenience with monthly dosing, and a favorable safety profile. This compelling dataset positions SLK as a potentially best-in-class IL-17A/F inhibitor.

HS and PsA represent multibillion dollar opportunities for SLK. The global HS market is projected to reach over $10 billion by 2035, driven by IL-17 inhibitors. SLK has shown unprecedented efficacy in this indication.

In PsA, IL-17 inhibitors are expected to become the leading drug class, commanding 35-40% of the >$10 billion market by 2031. SLK has exhibited differentiated performance that can help it capture significant share.

Beyond HS and PsA, SLK also holds potential in other large indications like plaque psoriasis, axial spondyloarthritis, and several dermatology and rheumatology diseases.

In total, MoonLake estimates a core market opportunity of $43 billion for SLK, not including adjacent indications that could expand the opportunity to over $150 billion. With its unique profile, SLK can potentially achieve multi-billion dollar peak sales.

In 2024, MoonLake expects:

- Full 24 week data from the Phase 2b trials in HS and PsA

- Initiation of Phase 3 programs in HS and PsA

- Initial data from additional Phase 2 trials

- Regulatory interactions to support Biologics License Application

With a cash runway expected to last until the end of Phase 3 trials, MoonLake is well-positioned to fully capture SLK's blockbuster potential. The company expects SLK to emerge as a leader in the growing multi-billion dollar IL-17 class. The IL-17 inhibitor class is dominated by Novartis' Cosentyx and recently, UCB's Bimekizumab. However, SLK has exhibited superior efficacy over both these agents in clinical trials.

No other IL-17 asset has matched SLK's ability to drive higher response rates so far. SLK's proposed monthly dosing regimen also gives it a convenience advantage. Among other pipeline assets, izokibep from Bristol Myers Squibb is the closest competitor, but it lacks head-to-head data versus SLK.

Overall, SLK is differentiated by its tri-specific nanobody construct enabling dual IL-17A/F inhibition, translated clinically into unprecedented outcomes in HS and PsA. This gives MoonLake the opportunity to establish SLK as a best-in-class IL-17 inhibitor.

MoonLake Immunotherapeutics has rapidly advanced a highly promising asset in Sonelokimab, demonstrating transformational potential in inflammatory diseases like HS and PsA.

SLK's unique tri-specific Nanobody structure, creating a novel dual IL-17A/F inhibitor, has driven best-in-class efficacy that can address high unmet needs.

The robust clinical dataset, combined with a strong financial position, strategically positions MoonLake to establish SLK as a leader in the multi-billion dollar IL-17 class. If executed successfully, SLK can achieve blockbuster sales while delivering superior outcomes for patients.