Contineum Therapeutics Reports Topline Data From Phase 2 VISTA Trial Evaluating PIPE-307 in Relapsing-Remitting Multiple Sclerosis
Contineum Therapeutics, Inc. (NASDAQ: CTNM) (“Contineum” or the “Company”), a clinical-stage biopharmaceutical organization advancing differentiated therapies across neuroscience, inflammation, and immunology (NI&I), announced the topline results from its Phase 2 VISTA clinical trial evaluating PIPE-307 in patients with relapsing-remitting multiple sclerosis (RRMS). PIPE-307 is an orally administered M1 muscarinic receptor antagonist designed to modulate neural pathways implicated in demyelinating diseases such as MS. The program emerged from Contineum’s broader strategy to target mechanisms believed to influence myelin repair, neuroinflammation, and overall neurological function.
The announcement marks a significant milestone for the Company’s clinical development efforts in RRMS, a chronic and often disabling disease affecting millions worldwide. Despite the availability of multiple disease-modifying therapies, many RRMS patients continue to experience disease progression, cognitive decline, and persistent symptoms that can substantially impact quality of life. Contineum has been pursuing innovative approaches that go beyond traditional immunomodulation, aiming instead to identify treatments capable of improving functional outcomes that remain unaddressed by current therapies.
Key Findings From the VISTA Phase 2 Trial
The VISTA trial was designed as a randomized, double-blind, placebo-controlled, multi-center study, with the goal of evaluating both the safety profile and clinical activity of PIPE-307. Participants received one of two dose levels of PIPE-307 or placebo over the trial period. The study incorporated a range of clinical and imaging endpoints, including functional vision-based metrics often used to assess neuro-ophthalmic manifestations of MS.
According to the topline results released today, PIPE-307 demonstrated acceptable safety and tolerability at both tested dose levels. No new or unexpected safety signals were reported, and overall treatment-emergent adverse events were consistent with previously observed data. This safety outcome, while encouraging, is only one aspect of the trial’s objectives.
From an efficacy standpoint, the study did not meet its prespecified primary or secondary endpoints. The primary endpoint was the change from baseline in binocular 2.5% low-contrast letter acuity (LCLA), a sensitive measure of visual function known to correlate with demyelination and neuroinflammatory activity in MS. Across all treatment arms—both PIPE-307 dose groups and placebo—no statistically significant difference was observed. Secondary endpoints, which included additional clinical assessments and MRI-based imaging measures, also failed to demonstrate meaningful separation between active treatment and placebo.
While these findings indicate that PIPE-307 did not achieve the clinical efficacy goals set for this Phase 2 program, Contineum emphasized that the dataset remains rich with exploratory information that may offer important scientific insights. The Company Contineum Therapeutics is continuing deeper analyses into the exploratory endpoints, which could include biomarker trends, imaging sub-analyses, or specific patient subgroup responses not captured in the topline release.
Leadership Perspective and Commitment to Innovation
Timothy Watkins, M.D., M.Sc., Chief Medical Officer and Head of Development at Contineum Therapeutics, expressed the Contineum Therapeutics Company’s disappointment in the trial’s efficacy results but reaffirmed its commitment to innovation and scientific rigor.
“We’re disappointed by these results, but are grateful to the VISTA trial investigators, and especially to the patients and their families,” Dr. Watkins said. “We intend to learn from these data and remain committed to pursuing novel therapies for patients with inflammatory and fibrotic diseases.”
Such sentiments reflect a broader industry reality: drug development in complex neurological conditions, including MS, carries inherent challenges due to the disease’s heterogeneity, the variability in clinical progression, and the intricate interplay of inflammatory and neurodegenerative processes. Setbacks in efficacy outcomes, while difficult, also offer valuable knowledge that can guide both scientific understanding and future therapeutic strategies.
Trial Overview and Scientific Rationale
PIPE-307 was investigated based on its mechanism as an M1 muscarinic receptor antagonist—a class of molecules believed to influence neuronal circuitry involved in myelin formation and neural repair. Preclinical evidence had suggested potential roles for M1 modulation in promoting remyelination or improving neuronal signaling efficiency, making it a compelling candidate for early-stage evaluation.
The VISTA trial (NCT06083753), which enrolled RRMS patients across multiple centers, was designed as a proof-of-concept study. Beyond visual function measures, the trial included a comprehensive battery of clinical assessments to evaluate cognitive performance, neurological function, and MRI-based measures of brain lesion activity and structural integrity. Although PIPE-307 did not yield positive efficacy results, the study’s structure and dataset are expected to enhance understanding of M1 antagonism in MS and may influence future directions for the Company’s NI&I pipeline.
Next Steps for PIPE-307 and Data Dissemination
Contineum has stated that it will continue conducting in-depth analyses of the VISTA dataset. Such analyses could help determine whether specific biomarkers, patient subgroups, or imaging features provide clues about differential responses, pharmacodynamic effects, or potential translational learnings relevant to other pipeline candidates.
The Company plans to present the full dataset at an upcoming medical meeting, allowing clinicians, researchers, and industry peers to review and discuss the results. In addition, Contineum intends to submit the study for publication in a peer-reviewed medical journal, ensuring that the scientific and medical community has broad access to the data and the opportunity to evaluate the trial’s implications in the context of ongoing RRMS research.
Despite the negative primary outcomes, the broader significance of conducting rigorous, well-controlled clinical trials cannot be understated. Each study contributes to a collective understanding of disease biology, therapeutic strategies, and patient needs. For Contineum, the VISTA results will help refine strategic prioritization across its NI&I programs and shape future research approaches aimed at addressing unmet needs in neurological and immunological diseases.
The topline results from the Phase 2 VISTA trial mark an important milestone for Contineum Therapeutics and its development of PIPE-307 for relapsing-remitting multiple sclerosis. While the study did not meet its primary or secondary efficacy endpoints, the acceptable safety profile and extensive dataset offer meaningful scientific value. Contineum remains committed to advancing innovative therapies for NI&I conditions and plans to share a detailed analysis of the VISTA findings with the broader medical community in the near future.
About Contineum Therapeutics
Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need. Contineum is advancing a pipeline of internally-developed programs with multiple drug candidates now in clinical trials. PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis and chronic pain. PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and major depressive disorder. For more information, please visit www.contineum-tx.com.
Source Link: https://www.businesswire.com/
