For US Healthcare Professionals Only

Are you ready for
an HS breakthrough?

At MoonLake Immunotherapeutics, we're proud to be the first company to select HiSCR75* as a primary endpoint in our clinical research into hidradenitis suppurativa (HS).^1-4

Visit ClinicalTrials.gov to learn more about our ongoing clinical trials in HS.

*HiSCR75 is defined as a ≧75% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining tunnel count relative to baseline.^2-4

Inflammatory diseases like HS need innovative thinking

HS is a severely debilitating chronic skin condition resulting in irreversible tissue destruction.^5,6

HS manifests as painful inflammatory skin lesions such as nodules and abscesses, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately-treated inflammation can result in the formation of draining dermal tunnels and scarring.^5,6

2.5%^*8 prevalence

HS is more common than previously recognized;⁷ worldwide, the prevalence of HS is now understood to be 2.5%*⁸

2.3 million people^†9

In the US alone, there are approximately 2.3 million people who have already been diagnosed with and treated for HS^†9

265,000 new patients every year⁹

The number of US patients with HS is expected to grow by approximately 265,000 every year,⁹ reaching ~5 million by 2035

*95% CI, 1.8-3.5%. Based on a systematic review and meta-analysis of studies using a validated questionnaire. ^†Based on healthcare insurance claims data extrapolated to the full US population.

There is a high unmet need among patients with HS.

In a survey of 1,299 patients with HS:^*10

9 out of 10 reported recent HS pain.

6 out of 10 reported moderate pain to the worst possible pain.

Patients report that their HS pain limits their mobility and sleep, harms their psychological wellbeing, and impairs their social relationships.¹¹

*Self-reported HS pain over the past week using a numeric rating scale.

US claims data reveal a high burden of comorbidities among patients with HS:*⁹

*At any time. By International Classification of Diseases chapters.

HS is a debilitating disease

Patients with HS also face negative impacts to multiple aspects of life, including impaired work productivity, impaired leisure activity, and sexual dysfunction.¹²

Do you unlock potential?

We’re working to unlock the full potential
of IL-17A and IL-17F inhibition.

Multiple immunological pathways—including the IL-17 pathway—have important roles in inflammatory conditions such as HS.^6,13

The proinflammatory cytokines IL-17A and IL-17F are both highly elevated in HS lesions.⁶

This provides a rationale for the established approach of targeting both IL-17A and IL-17F to interrupt the HS inflammatory cascade.^6,13

If left unchecked, this cascade can lead to irreversible tissue destruction, including the formation of deep dermal inflammatory lesions such as abscesses and draining tunnels.⁶

Deep dermal tunnels/sinus tracts — Adapted from Krueger JG, et al.⁶

We’re researching ways to build on the established understanding of IL-17 inhibition and exploring the role of deep tissue penetration in addressing inflammation.^6,14

Do you still antibody?

At MoonLake Immunotherapeutics, we are researching Nanobody^® approaches.

Do you reach deep enough?

We're researching the importance of tissue penetration to address deep inflammation in diseases such as HS.¹⁴

What is a Nanobody^®?

A Nanobody and a traditional therapeutic antibody — A Nanobody® and a traditional therapeutic antibody

Nanobodies® are a class of biologics that are smaller than traditional antibodies.¹⁵

While traditional therapeutic antibodies consist of 2 heavy chains and 2 light chains connected with disulfide bonds...¹⁶

A naturally occurring class of antibodies with 2 heavy chains only

...there are also naturally occurring antibodies that consist of 2 heavy chains only.^15,17

The target-binding region of this type of antibody comprises a single VHH domain that has a strong affinity for its target¹⁸

These VHH domains can be isolated to act on their own as small therapeutic antibody fragments, or Nanobodies.®¹⁸

A Nanobody comprising multiple domains — A Nanobody® comprising multiple domains

A Nanobody® may be either a single VHH domain or constructs of multiple domains that may bind different targets.¹⁸

We're not content to settle when it comes to improving outcomes for the millions of people in the US who are living with HS.

References

ClinicalTrials.gov. Available at: https://clinicaltrials.gov/expert-search?term=AREA%5BPrimaryOutcomeMeasure%5DHiSCR75%20OR%20AREA%5BPrimaryOutcomeMeasure%5D%22Hidradenitis%20Suppurativa%20Clinical%20Response%2075%22%20OR%20AREA%5BPrimaryOutcomeMeasure%5D%22HiSCR%2075%22&sort=StudyFirstPostDate. Accessed February 2025.
ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06411899. Accessed February 2025.
ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06411379. Accessed February 2025.
ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05322473. Accessed February 2025.
Sabat R, et al. Lancet. 2025;405(10476):420-438.
Krueger JG, et al. BR J Dermatol. 2024;190(2):149-162.
Li Y, et al. Symposium on Hidradenitis Suppurative Advances. 2024. Abstract 3000296.
Zahid JA, et al. Dermatology. 2024. doi: 10.1159/000537920. Online ahead of print.
Charrow AP, et al. Symposium on Hidradenitis Suppurative Advances. 2024. Abstract 3000365.
Garg A, et al. J Am Acad Dermatol. 2020;82(2):366-376.
Orenstein LAV, et al. Br J Dermatol. 2023;188(1):41-51.
Kimball A, et al. Dermatol Ther (Heidelb). 2024;14(1):83-98.
Navarro-Compán V, et al. Front Immunol. 2023;14:1191782.
Reich K, et al. European Academy of Dermatology and Venereology 2024. Abstract 602.
Tijink BM, et al. Mol Cancer Ther. 2008;7:2288-2297.
Jovčevska I, Muyldermans S. BioDrugs. 2020;34:11-26.
Hamers-Casterman C, et al. Nature. 1993;363:446-448.
Muyldermans S. Annu Rev Anim Biosci. 2021;9:401-421.

Abbreviations

HiSCR75, HS clinical response 75 (≥75% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining tunnel count relative to baseline^2–4); HS, hidradenitis suppurativa;
VVH, Heavy chain variable domain from a heavy-chain-only antibody.

Nanobody^® and Nanobodies^® are registered trademarks of Ablynx, a Sanofi company.

Date of preparation: February 2025

Are you ready for an HS breakthrough?