Contineum's Depression Drug Misses Primary Endpoint in Phase 2 Trial

Contineum Therapeutics' partnered depression drug JNJ-5120/PIPE-307 has failed to meet its primary endpoint in a Phase 2 trial, disappointing investors. Developed and licensed by Johnson & Johnson (NYSE:JNJ), the drug aimed to target the muscarinic M1 receptor as a rapidly acting treatment for major depressive disorder (MDD). The MOONLIGHT-1 study enrolled 107 adults with MDD and evaluated JNJ-5120/PIPE-307 as a monotherapy, but it failed to demonstrate the required efficacy in improving MADRS scores at Day 5 relative to placebo.

Despite this setback, Contineum notes that the drug was well-tolerated with no new safety signals. However, this does not offset the primary endpoint failure. Johnson & Johnson is continuing to analyze the broader dataset and prespecified exploratory endpoints before determining next steps for the program.

The study's result raises concerns about the efficacy of JNJ-5120/PIPE-307 in treating MDD, particularly given that it was designed as a proof-of-concept study. This is not the first disappointing clinical readout involving PIPE-307, which previously failed to demonstrate a benefit on its primary efficacy measure in patients with relapsing-remitting multiple sclerosis.