Contineum Therapeutics Inc. (NASDAQ: CTNM) experienced a decline in its share price in after-hours trading on Monday after announcing that the phase 2 MOONLIGHT-1 study of JNJ-5120/PIPE-307 in major depressive disorder did not meet its primary efficacy endpoint.
The trial's primary measure assessed change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 5 compared with placebo. According to the company, JNJ-5120/PIPE-307 did not demonstrate a statistically significant improvement on that primary endpoint.
Contineum said the investigational therapy was well-tolerated in the study population and that no new safety signals were observed. The company reiterated that the safety profile did not reveal unexpected adverse findings during the MOONLIGHT-1 trial.
JNJ-5120/PIPE-307 is being advanced under a global license and development agreement with Johnson & Johnson. Per the announcement, Johnson & Johnson is continuing its review of the trial dataset, including prespecified exploratory endpoints, and will assess the overall findings and their clinical relevance to determine appropriate next steps for the candidate.
The MOONLIGHT-1 trial was designed as a randomized, double-blind, multicenter, placebo-controlled, proof-of-concept study. It evaluated the efficacy, safety and tolerability of JNJ-5120/PIPE-307 as a monotherapy in adult participants diagnosed with major depressive disorder.
Contineum Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapies targeting inflammatory and fibrotic diseases. The company emphasized the trial outcome and noted the ongoing assessment by Johnson & Johnson as part of the development partnership.
Context and next steps
- The company reported the primary efficacy endpoint was not met in MOONLIGHT-1; safety signals remained consistent with prior observations.
- Johnson & Johnson, as the development and license partner, is reviewing the full dataset, including exploratory endpoints, to evaluate the totality and clinical relevance of the results.
- Contineum remains a clinical-stage developer of small molecule therapies for inflammatory and fibrotic conditions.
What this means for stakeholders
Investors and other stakeholders should note that the reported outcome relates specifically to the primary efficacy endpoint in this phase 2 study of JNJ-5120/PIPE-307 in major depressive disorder. The announcement confirmed tolerability and an absence of new safety signals, while placing the responsibility for further data assessment with Johnson & Johnson under the existing development agreement.