A phase 2 study of Johnson & Johnson’s JNJ-5120 has failed to achieve its primary goal, raising fresh questions about the future of the depression treatment licensed from Contineum Therapeutics.
J&J secured global rights to the M1 receptor antagonist, also known as PIPE-307, in 2023 through a deal that provided Pipeline Therapeutics with $50 million upfront and included the potential for as much as $1 billion in milestone payments. Pipeline later changed its name to Contineum in 2023 after completing two Phase 1 studies of the drug, paving the way for J&J to advance it into midstage trials for relapsing-remitting multiple sclerosis (MS) and major depressive disorder (MDD).
The latest setback comes 10 months after Contineum disclosed that JNJ-5120 had also failed to improve vision in a Phase 2 MS study. In the MDD trial, 107 participants were randomly assigned to one of two JNJ-5120 dosing regimens or placebo.
At the fifth day, the JNJ-5120 regimen produced no greater improvement on the depression scale than the placebo, resulting in failure to meet the study’s primary endpoint. William Blair analysts subsequently removed the drug from their valuation model, effectively abandoning the 35% probability of success they had assigned to the program ahead of the results.
The analysts had previously considered the trial particularly challenging because placebo-controlled MDD studies can produce substantial placebo effects that reduce apparent treatment benefits. They also pointed to differences among patients as another source of variability in responses to active treatment.
Despite the disappointing result, J&J has not yet discontinued development of JNJ-5120. Contineum said its partner is continuing to assess the findings, including results from prespecified exploratory endpoints. J&J’s evaluation of the overall dataset and the clinical significance of the findings will determine what happens to the program in the near future.
The market reaction was relatively restrained. Contineum’s shares fell less than 4% to $14.30 in after-hours trading, suggesting investors had already assigned limited value to the depression program. That reaction was broadly consistent with William Blair’s assessment that much of Contineum’s valuation is instead supported by PIPE-791, its LPAR1 antagonist being developed for idiopathic pulmonary fibrosis.
PIPE-791 is currently in Phase 2 development and could eventually compete with Bristol Myers Squibb’s admilparant. According to the analysts, the next major potential catalyst for Contineum’s stock will be data from the Phase 3 admilparant program, which BMS is expected to report early in the fourth quarter.
It’s been a busy period for J&J, as the firm just also introduced a new policy requiring healthcare providers to furnish detailed pharmacy and medical claims information whenever one of the company’s medicines is dispensed under the 340B program. The requirement applies broadly across participating organizations, including hospitals and community health centers, although providers involved in HIV/AIDS programs are excluded.
For most J&J medicines, participating providers have 45 days to supply the requested records. The documentation can include information such as the date a prescription was filled and identification numbers associated with the clinicians who prescribed the medication.
Contineum has reported another setback for its investigational depression drug after the treatment failed to meet the required objectives in a Phase 2 clinical trial. The result adds to challenges surrounding the program and its future development.
Phase 2 trials are designed to provide important evidence about a medicine’s effectiveness and safety in a larger patient population than early-stage studies. For Contineum, the latest results provide researchers with additional information about the performance of the investigational treatment.
Contineum and Depression Treatment Research
Depression remains an area of significant pharmaceutical research, with companies investigating new approaches for patients who do not respond adequately to existing therapies. Contineum’s program is part of this broader effort to develop additional treatment options.
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