Benzinga - by Vandana Singh, Benzinga Editor.
On Sunday, MoonLake Immunotherapeutics (NASDAQ:MLTX) announced that continued treatment with Nanobody sonelokimab led to significant improvements across all key outcomes at 24-week data from the ARGO trial in psoriatic arthritis (PsA).
The 207-patient ARGO trial demonstrated that the primary endpoint, the American College of Rheumatology (ACR) 50, continued to improve from week 12 and exceeded 60% by week 24.
The more rigorous ACR70 outcome was achieved by approximately 40% of patients by week 24.
In addition, by week 24, over 80% and 60% of patients treated with sonelokimab achieved Psoriasis Area Severity Index (PASI) 90 and 100, respectively. Both doses of sonelokimab yielded similar results.
The company said the responses surpassed those for AbbVie Inc’s (NYSE:ABBV) Humira (adalimumab), the active reference arm in the study, and were also higher when indirectly compared to competitors using the same active reference arm as a standard.
Treatment with sonelokimab resulted in unprecedented improvements in composite scores that reflect responses in different domains simultaneously.
ACR50+PASI90 up to 59%, ACR 50+PASI 100 up to 52%, ACR 70+PASI 100 up to 48%, and MDA up to 61% response.
In all composite scores, sonelokimab showed 16-29 percentage point differences to the reference adalimumab arm, comparatively higher than competitors using the same reference arm.
Monthly maintenance with 60mg or 120mg doses showed leading responses above the TNF reference arm across all key outcomes, including in higher treatment goals (ACR70, PASI100, composites) – 120mg added benefit for specific patient subgroups.
The safety profile of sonelokimab was consistent with previous trials, and no new safety signals were detected.
MoonLake intends to commence Phase 3 trials in hidradenitis suppurativa (HS) in the second quarter 2024 under the VELA program that will enroll 800 patients, with top-line primary endpoint data expected as early as mid-2025.
MoonLake says it would commence four additional clinical trials of sonelokimab across dermatology and rheumatology, including palmo-plantar pustulosis, juvenile HS, and seronegative spondyloarthritis.
Price Action: MLTX shares are up 3% at $46.98 on the last check Monday.
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