MoonLake's psoriatic arthritis drug meets key goals in late-stage trial

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MoonLake Immunotherapeutics said on Monday its experimental drug met all ​main goals in a late-stage trial involving adults with an inflammatory ‌disease who had not previously received biologic medicines.

However, shares of the Switzerland-based company fell more than 8% in premarket trading amid investor concerns about how the drug stacks up ​against UCB’s Bimzelx, an FDA-approved biologic for the condition.

  • Psoriatic arthritis ​is a type of arthritis that can affect people who ⁠have psoriasis, a skin condition that causes itchy, scaly patches on the ​skin.
  • In the study, 42.1% of patients with psoriatic arthritis receiving a 60 mg ​dose of sonelokimab after an initial induction dose achieved a significant improvement in symptoms by week 16, MoonLake said.
  • 66.5% of patients achieved at least a 20% improvement in psoriatic arthritis ​symptoms, while 41.2% reached minimal disease activity. Among patients with skin-related symptoms, ​61% saw a major improvement in psoriasis, the company added.
  • Patients also reported better physical function ‌and ⁠quality of life, with no new safety concerns identified, MoonLake said.
  • MoonLake did not disclose how sonelokimab performed against placebo, saying treatment-group comparisons would remain blinded until the late-stage program was completed.
  • Clear Street analyst Kaveri Pohlman told Reuters MoonLake’s ​data for sonelokimab ​was strong and ⁠largely matched results seen with UCB’s Bimzelx.
  • The stock’s decline likely reflected investor expectations for a clearer advantage over Bimzelx, ​Pohlman said, while the absence of a placebo arm also ​made ⁠it difficult to assess the magnitude of benefit relative to placebo.
  • The late-stage study will continue through 52 weeks, with full results expected in the first half of ⁠2027.
  • Sonelokimab, ​MoonLake’s lead drug candidate, is also being evaluated ​for the treatment of hidradenitis suppurativa, a chronic skin disease characterized by painful, boil-like lumps that ​form beneath the skin.