Contineum's JNJ-5120/PIPE-307 Misses Primary Endpoint in Phase 2 MOONLIGHT-1 Depression Trial
核心洞察
The Phase 2 MOONLIGHT-1 trial of JNJ-5120/PIPE-307 (搜索) did not meet its primary efficacy endpoint in adults with major depressive disorder (搜索), Contineum Therapeutics reported.
The trial assessed improvement from baseline in MADRS total score at Day 5 versus placebo; the M1 receptor (搜索) inhibitor was well-tolerated with no new safety signals.
Johnson & Johnson, which develops the drug under a global license agreement, is analyzing prespecified exploratory endpoints to assess clinical relevance and next steps.
Contineum Therapeutics announced that the Phase 2 MOONLIGHT-1 trial of JNJ-5120/PIPE-307 (搜索) did not achieve its primary efficacy endpoint in adults with major depressive disorder (搜索) (MDD). The trial evaluated improvement from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 5 compared with placebo, according to the company's September 14, 2026 announcement.
JNJ-5120/PIPE-307 (搜索) was well-tolerated in the study, with no new safety signals reported. The drug candidate is a selective inhibitor of the M1 receptor (搜索) and is being developed by Johnson & Johnson under a global license and development agreement with Contineum.
Johnson & Johnson continues to evaluate the trial data, including data related to prespecified exploratory endpoints, and is assessing the totality and clinical relevance of the findings to inform next steps for JNJ-5120/PIPE-307 (搜索). Contineum noted that analyses of the data, including prespecified exploratory endpoints, are ongoing.
Trial Design and Population
MOONLIGHT-1 is a randomized, double-blind, multicenter, placebo-controlled, proof-of-concept trial evaluating the efficacy, safety and tolerability of JNJ-5120/PIPE-307 (搜索) as monotherapy in adult participants with MDD. The study is registered on clinicaltrials.gov under identifier NCT06785012.
Enrollment in the trial was completed in June 2026, with 107 adult participants, as reported in Contineum's second-quarter 2026 financial results. At that time, Contineum chief executive officer Carmine Stengone highlighted the milestone, stating that Johnson & Johnson had completed enrollment for the Phase 2 MOONLIGHT-1 trial of JNJ-5120/PIPE-307 (搜索) in patients with MDD.
PIPE-791 Advances in Idiopathic Pulmonary Fibrosis
While the depression program reported a negative primary endpoint, Contineum affirmed progress in its lead clinical program. PROPEL-IPF, a global Phase 2 trial evaluating PIPE-791 for the treatment of patients with idiopathic pulmonary fibrosis (搜索) (IPF), now has more than 55 sites online across eight countries to enable a steady pace of enrollment, the company said.
Contineum initiated patient dosing in PROPEL-IPF in the first quarter of 2026. The trial is a 26-week, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, tolerability and pharmacokinetics of once-daily, oral PIPE-791 in approximately 324 IPF patients. The primary efficacy endpoint is the change from baseline through week 26 in absolute forced vital capacity (FVC mL). The trial is registered under NCT07284459.
PIPE-791 is an LPA1 receptor (搜索) antagonist in clinical development for IPF and chronic pain (搜索). On April 30, 2026, Contineum reported positive topline data from an exploratory Phase 1b trial of PIPE-791 for the non-opioid treatment of chronic osteoarthritis pain (搜索) or chronic low back pain (搜索). That trial met its primary objective of assessing safety and tolerability, demonstrating an adverse event profile generally consistent with previous PIPE-791 clinical trials. In addition, patients treated with PIPE-791 generally demonstrated improvements from baseline in pain that were numerically greater than the placebo arm. Contineum believes these data support further evaluation of PIPE-791 for the potential treatment of chronic pain. The trial is registered under NCT06810245.
Pipeline Reprioritization and Financial Position
Alongside its clinical updates, Contineum said it has streamlined its discovery programs to focus on drug candidates for the treatment of inflammatory and fibrotic diseases. These actions resulted in a limited workforce reduction for the company's research team, including chief scientific officer Daniel Lorrain, Ph.D.
"We're focused on advancing our highest potential and greatest probability-of-success clinical programs, led by our global Phase 2 PROPEL-IPF trial," Stengone said. "We are dedicating our discovery, translational science and clinical development resources to align behind advancing potential treatments for inflammatory and fibrotic diseases. With a projected cash runway that extends through mid-2029, which is approximately one year past the estimated completion of our IPF trial, we are maintaining a disciplined approach to capital allocation."
As of June 30, 2026, Contineum reported cash, cash equivalents and marketable securities of $236.6 million, which the company believes is sufficient to fund planned operations through mid-2029. Research and development expenses were $12.7 million, a 10 percent decrease from the second quarter of 2025, driven primarily by reduced expenses related to completion of the PIPE-307 VISTA trial and lower costs for the PIPE-791 chronic pain (搜索) trial, partially offset by increased spending on the PIPE-791 IPF program and higher employee-related costs. General and administrative expenses were $4.7 million, a 23 percent increase from the second quarter of 2025, primarily due to higher stock-based compensation and employee-related costs. Net loss was $15.2 million for the three months ended June 30, 2026, compared with $16.0 million in the second quarter of 2025.
Contineum noted that it is heavily dependent on the success of PIPE-791 and PIPE-307, both of which remain in early stages of clinical development, and that neither candidate may progress through clinical development or receive regulatory approval. Under the global license and development agreement, Janssen Pharmaceutica NV, a Johnson & Johnson company, develops PIPE-307 for MDD or any other indication at its sole discretion, and restrictions in that agreement limit Contineum's access to, and ability to disclose, certain information regarding the development of PIPE-307.