MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company based in Zug, Switzerland, specializing in developing next-generation therapies for inflammatory diseases, notably through its investigational Nanobody therapy, sonelokimab.
Why did you decide to found a biotech with a focus on nanobodies?
Nanobodies have the potential to overcome the limitations of monoclonal antibodies. They are smaller, more stable, easier to manufacture, and can target multiple sites of inflammation simultaneously, offering a leap forward in treating autoimmune diseases. This approach excites us because nanobodies can penetrate tissues more effectively, allowing for better targeting of diseases deep within body tissues. With nanobodies, we can offer a more convenient and effective treatment for patients while addressing significant unmet medical needs.
Are you pioneers in utilizing nanobodies in medicine?
In some ways, yes. We are at the forefront of clinical development with nanobodies, particularly in treating autoimmune diseases. Our work aims to bring these technologies to the mainstream, showing that nanobodies can not only create business opportunities but also address significant healthcare challenges. We are focusing on diseases with large patient populations and unmet medical needs, demonstrating the real-world applications and potential of nanobodies.
However, we did not invent nanobodies—these were discovered in the 90s, primarily in animals like alpacas, which naturally produce smaller antibodies known as nanobodies. The real pioneering work in nanobodies was done by companies like Ablynx, which developed the technology to scale for clinical use. While we did not invent them, we are taking nanobodies to the next level. Our goal is to make nanobodies a viable treatment option for millions of patients worldwide.
You have some important news coming up soon pertaining to your pipeline…
Yes! MoonLake is focused on a single asset, the nanobody sonelokimab, which is currently being developed for dermatology and rheumatology. We are progressing a total of eight Phase 2 and Phase 3 clinical trials, plus other ancillary trials and are targeting significant diseases with large patient populations and a total addressable market worth over $200 billion. Our primary focus in dermatology is on hidradenitis suppurativa, a condition that affects 2-3% of the global population. We are in Phase 3 for this indication and expect to announce top line results around mid-2025. Additionally, we have a Phase 2 trial for palmoplantar pustulosis, a rare skin condition with no existing therapies, and we plan to announce the results this year.
In rheumatology, sonelokimab is being developed for psoriatic arthritis, a disease affecting 1% of the population. While there is some competition in this area, our drug targets inflammation across multiple domains, not just the joints or skin. We started Phase 3 for psoriatic arthritis in 2024, and we expect to see results in 2026. Additionally, we are conducting a dedicated adolescent trial for hidradenitis suppurativa, the first of its kind, aiming to treat this disease early before long-term damage occurs.
What other applications do you see for nanobodies beyond autoimmune diseases?
Nanobodies have a wide range of potential applications beyond autoimmune diseases. For example, they are being explored in oncology, where their small size allows them to penetrate tumors more effectively. Nanobodies can also be attached to fluorescent molecules for use in surgical procedures to help delineate tumors and minimize damage to surrounding tissue. Additionally, nanobodies are being investigated in diagnostic platforms, offering a new approach to detecting diseases. Their versatility makes them suitable for targeting multiple disease pathways, and we believe they hold promise for treating a variety of complex conditions.
The true strength of nanobodies lies in their ability to target deep within the body and modulate multiple mechanisms of action simultaneously. This makes them particularly valuable for diseases that require multi-target treatments. As we continue to develop sonelokimab, we anticipate their application will expand to various other fields.
As a Swiss biotech, do you think MoonLake faces more challenges attracting capital compared to its US counterparts?
From my experience, I don’t believe there are significant differences between biotech companies in Switzerland and the US when it comes to seeking capital. The key to success is having a great idea and connecting with the right investors. In the US, there is a highly sophisticated and fast-moving investment community that can provide significant support to promising companies. While there may be legal differences between Switzerland and the US, these are minor details in the grand scheme of things. What truly matters is the strength of your idea and your ability to pitch it to the right investors.
Switzerland is a great location for biotech companies, but the focus should always be on building relationships with investors, particularly in the US, where the biotech sector is more mature. Investors in the US are more likely to move quickly and provide the necessary funding to scale up. So, regardless of where you're based, it’s essential to focus on your idea, connect with the right people, and take advantage of the global investment opportunities available.
