MoonLake Immunotherapeutics has achieved promising results in a phase 2 trial for its IL-17 inhibitor, sonelokimab, aimed at treating inflammatory skin conditions, particularly psoriatic arthritis. The trivalent camelid nanobody showed a statistically significant response in patients with active psoriatic arthritis, with 46% and 47% of those receiving the 60-mg and 120-mg doses, respectively, experiencing a 50% or greater reduction in disease activity at Week 12, meeting the primary endpoint.
Notably, MoonLake’s study included patients with an initial induction period, and the 60-mg dose without induction did not reach statistical significance. Consequently, the biotech plans to advance the 60-mg and 120-mg doses with induction into phase 3 trials.
The ARGO trial, involving 207 patients, also showed that sonelokimab met all its secondary endpoints, including a 90% or greater improvement from baseline on the Psoriasis Area and Severity Index score for both doses with induction.
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Comparatively, AbbVie’s Humira, a widely used treatment for psoriasis, was used as an active reference in the trial. While the study was not statistically powered for comparison, MoonLake claimed that both sonelokimab doses “numerically outperformed” Humira on the primary endpoint and all key secondary endpoints. This data suggests that sonelokimab has the potential to become a leading therapy in the field.
However, despite these positive results, investors appeared less enthusiastic, causing a 30% drop in MoonLake’s stock to approximately $36 in pre-market trading.
“As part of our efforts to elevate outcomes for patients, we set ambitious goals for our Nanobody sonelokimab. ARGO is MoonLake’s third Phase 2 trial and the first trial in psoriatic arthritis using a Nanobody to report positive topline results, setting another landmark milestone. Again, we met the objectives we set out for ourselves, in this case for PsA. As with our hidradenitis suppurativa program, the preparation of our Phase 3 program in PsA is rapidly advancing and expected timing of end-of-Phase 2 regulatory meetings will be announced in due course.”
– Jorge Santos da Silva, PhD, Founder and Chief Executive Officer at MoonLake
This success comes after a previous phase 2 trial for sonelokimab in another skin condition, hidradenitis suppurativa (HS), which boosted the Swiss biotech’s stock by 62% in June, reaching around $50 per share. The competitive landscape in the IL-17 inhibitor market has been reshaped, with MoonLake’s sonelokimab now holding promise after the failure of Acelyrin’s izokibep in a phase 2b/3 trial for severe HS in September.
Jefferies analysts have adjusted their projections due to these developments, anticipating that sonelokimab will achieve a peak penetration of 35% in the US and 15% in the EU, both in post-TNF HS patients by 2035. This showcases the potential of sonelokimab in the IL-17 inhibitor market, which remains a hot area of research and development.
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“The positive topline results from the pivotal-like ARGO trial establish the Nanobody sonelokimab as an innovative potential treatment in another chronic inflammatory disease, psoriatic arthritis. Importantly, the results confirm our expectations in terms of dosing, clinical responses and safety findings. We believe that we have elevated the therapeutic bar by reaching important clinical outcomes at week 12. The data also support sonelokimab’s unique molecule characteristics and mode of action to effectively inhibit IL-17F in addition to IL-17A in deep tissue inflammation. The positive outcome of the ARGO trial would not have been possible without the support and participation of the patients and investigators to whom we are grateful.”
– Kristian Reich, MD, PhD, Founder and Chief Scientific Officer at MoonLake
