Contineum Therapeutics Phase‑2 MOONLIGHT‑1 Trial Outcome
Contineum Therapeutics Inc. (NASDAQ:CTNM) reported that its phase‑2 MOONLIGHT‑1 study of the experimental compound JNJ‑5120/PIPE‑307 in major depressive disorder did not meet the primary efficacy endpoint. The primary endpoint required a statistically significant improvement from baseline in the Montgomery‑Åsberg Depression Rating Scale total score at Day 5 compared with placebo. Consequently, Contineum’s shares fell 8% in after‑hours trading on Monday.
The trial was a randomized, double‑blind, multicenter, placebo‑controlled, proof‑of‑concept study assessing the efficacy, safety, and tolerability of JNJ‑5120/PIPE‑307 as monotherapy in adult participants with major depressive disorder. While the efficacy target was not achieved, the company noted that the drug was well‑tolerated and no new safety signals emerged during the study.
JNJ‑5120/PIPE‑307 is being developed under a global license and development agreement with Johnson & Johnson. Johnson & Johnson indicated that it will continue to evaluate the trial data, including prespecified exploratory endpoints, and will assess the totality and clinical relevance of the findings to determine subsequent steps for the drug candidate.
Contineum Therapeutics describes itself as a clinical‑stage biopharmaceutical company focused on developing small‑molecule therapies for inflammatory and fibrotic diseases.