By MoonLake Immunotherapeutics saw its shares double to $55 in premarket trading following positive trial results. The global Phase 2 trial evaluated the safety and efficacy of the Nanobody sonelokimab in patients with moderate-to-severe hidradenitis suppurativa.
According to MoonLake, the trial recruited 234 patients and used Hidradenitis Suppurativa Clinical Response 75 as its primary endpoint, which is a higher measure of clinical response than the HiSCR50 measure used in previous trials.
At week 12, a greater proportion of patients treated with sonelokimab 120mg and 240mg achieved HiSCR75 compared to those on placebo. The trial met its primary endpoint based on an intent-to-treat non-responder imputation, which is the most stringent type of analysis for such trials.
The results suggest that sonelokimab reaches the highest clinical activity of all other therapies tested in similar trials as early as week 12. Sonelokimab’s safety profile was consistent with previously reported studies, showing a favorable safety profile in line with known IL-17 inhibitors.
Sonelokimab is also being evaluated in a Phase 2 trial for patients with active psoriatic arthritis, and results are expected in Q4 of this year. However, it is not yet approved for use in any indication.
Conclusion
MoonLake Immunotherapeutics’ positive trial results have led to a surge in its shares, doubling the price to $55. The trial recruited 234 patients and used a higher measure of clinical response. The stringent analysis was based on non-responder imputation, meeting the primary endpoint. Results suggest that sonelokimab is more effective than other therapies tested in similar trials and has a favorable safety profile. The company expects results from a Phase 2 trial on psoriatic arthritis later this year, and the drug is not approved for use yet.
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