Johnson & Johnson's MDD Treatment Fails Phase 2 Trials

Johnson & Johnson's JNJ-5120/PIPE-307, a treatment for major depressive disorder (MDD), has failed to meet its primary efficacy endpoint in phase 2 trials. The MOONLIGHT-1 study, which evaluated the efficacy and safety of JNJ-5120/PIPE-307 as monotherapy in adult participants with MDD, found that the drug missed its day-5 MADRS improvement goal.

The trial, which involved 107 individuals with MDD who were randomly assigned to receive one of two JNJ-5120/PIPE-307 regimens or a placebo, showed that the drug was well-tolerated but did not demonstrate significant efficacy in reducing symptoms of depression. This is not the first failure for JNJ-5120/PIPE-307, as its phase 2 trial for relapsing-remitting multiple sclerosis also missed its primary endpoint.

Johnson & Johnson acquired PIPE-307 from Pipeline Therapeutics (now known as Contineum) in 2023 for $50 million upfront and up to $1 billion in global rights. The company had initiated midphase studies in both MDD and MS after taking over the asset, but this latest failure raises questions about its potential.