Contineum's MOONLIGHT-1 Phase 2 trial fails to hit primary endpoint in depression

Contineum Therapeutics announced on September 14, 2026 that its Phase 2 MOONLIGHT-1 trial did not achieve its primary efficacy endpoint for JNJ-5120/PIPE-307 in the treatment of major depressive disorder.¹

The trial design measured improvement from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 5 compared with placebo.¹ On safety, the company said JNJ-5120/PIPE-307 was well-tolerated with no new safety signals.¹

The drug is being advanced under a licensing arrangement, as JNJ-5120/PIPE-307 is being developed by Johnson & Johnson under a global license and development agreement.¹ Under the terms of that agreement, the risk disclosures specify the Company's reliance, pursuant to a global license and development agreement, upon Janssen Pharmaceutica NV, a Johnson & Johnson company, to develop, in its sole discretion, PIPE-307 for MDD or for any other indication.¹

Contineum said Johnson & Johnson continues to evaluate the trial data, including data related to prespecified exploratory endpoints, and assess the totality and clinical relevance of the findings to inform next steps for JNJ-5120/PIPE-307.¹

The study itself is described as a randomized, double-blind, multicenter, placebo-controlled, proof-of-concept trial evaluating the efficacy, safety and tolerability of JNJ-5120/PIPE-307 as monotherapy in adult participants with MDD.¹ Additional trial details are listed on clinicaltrials.gov under NCT06785012.¹

Contineum separately noted that its internally developed program, PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis and chronic pain.¹