FDA Clears MoonLake's Nanobody Study For Arthritis Patients

  • The FDA has signed off MoonLake Immunotherapeutics AG's  MLTX Phase 2 study of the nanobody sonelokimab in patients with active psoriatic arthritis (PsA). 
  • This is a global clinical study that also includes several European countries.
  • This new study is subsequent to the completion of a global Phase 2b study in moderate-to-severe psoriasis and the initiation of Phase 2 MIRA study in moderate-to-severe hidradenitis suppurativa.
  • Related: HC Wainwright Starts Coverage On This 'Best-In-Class Agent For Inflammatory Disorders.
  • The global, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of different doses of sonelokimab compared to placebo, with adalimumab as an active reference arm, in approximately 200 patients with active PsA. 
  • The study's primary endpoint is the percentage of participants achieving ≥50% improvement in signs and symptoms of the disease from baseline, compared to placebo. 
  • This study is the first in PsA to use the Nanobody.
  • Patient enrollment is expected to begin in 2022.
  • Price Action: MLTX shares are up 0.55% at $7.35 on the last check Monday.
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