Sunday, MoonLake Immunotherapeutics MLTX released topline results from its global Phase 2 ARGO trial of Nanobody sonelokimab in patients with active psoriatic arthritis (PsA).
The ARGO trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an American College of Rheumatology (ACR) 50 response compared to those on placebo at week 12.
For the 60mg and 120mg doses with induction, respectively, 46% and 47% of patients treated with sonelokimab achieved ACR50 (p<0.01 versus placebo); 78% and 72% of patients achieved ACR20; and 29% and 26% achieved ACR70.
The company said that, as expected, the 60mg dose without induction did not reach statistical significance, confirming the 60mg and 120mg with induction as the potential dose regimens to carry forward into Phase 3.
The key secondary endpoint Psoriasis Area and Severity Index (PASI) 90 was met for all doses with induction; 77% of patients responding at week 12 to the 60mg dose (ITT-NRI, p<0.001 versus placebo).
For this dose, 58% of patients achieved complete skin clearance (PASI100) at week 12.
Price Action: MLTX shares are down 21.30% at $40.37 on the last check Monday.
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