• Phase 2 MOONLIGHT-1 trial did not meet its primary efficacy endpoint
  • Analyses of the data, including prespecified exploratory endpoints, are ongoing

Contineum Therapeutics, Inc. (NASDAQ:CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated small molecule therapies for inflammatory and fibrotic diseases with significant unmet need, today announced that the MOONLIGHT-1 trial did not achieve its primary efficacy endpoint. The trial evaluated improvement from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 5 compared with placebo. JNJ-5120/PIPE-307 was well-tolerated with no new safety signals.

JNJ-5120/PIPE-307 is being developed by Johnson & Johnson under a global license and development agreement. 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.

The Phase 2, MOONLIGHT-1 study is 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. More information on this trial can be found at https://clinicaltrials.gov (NCT06785012).