Contineum Therapeutics, Inc. (NASDAQ: CTNM) has announced the completion of targeted enrollment for its Phase 2 PIPE-307 VISTA trial, a study evaluating the safety and efficacy of PIPE-307 in patients with relapsing-remitting multiple sclerosis (RRMS). The trial reached its goal of 168 participants in December 2024, ahead of schedule.
The Phase 2 VISTA trial (NCT06083753) is a randomized, double-blind, placebo-controlled, multi-center study designed to assess the potential of PIPE-307 as a novel treatment for RRMS. PIPE-307 is a potentially first-in-class M1 receptor antagonist that aims to promote remyelination, the restoration of the myelin sheath around nerve fibers, which is damaged in MS. The trial is being conducted across 21 sites in the U.S.
Trial Design and Endpoints
The VISTA trial will evaluate two different doses of PIPE-307 against a placebo in adults aged 18 to 50 with RRMS who are already receiving a standard disease-modifying therapy. Treatment will be administered for 26 weeks (approximately 6.5 months). The primary goals of the Phase 2 trial are to assess the safety of PIPE-307 and to evaluate changes in visual acuity, which can indicate improved myelination in the optic nerve. Secondary endpoints include additional vision measures, changes in walking function, dexterity, cognition, and disease biomarkers.
The trial is designed to measure multiple clinical and imaging endpoints sensitive to changes in remyelination in RRMS. Contineum anticipates that the last patient will complete the PIPE-307 VISTA trial in the third quarter of 2025.
PIPE-307: A Novel Approach to Remyelination
Multiple sclerosis is characterized by an inflammatory response that damages the myelin sheath, disrupting nerve signal transmission. While existing therapies can reduce inflammation and slow myelin damage, they do not reverse existing damage. PIPE-307 is designed to enhance remyelination by promoting the differentiation of oligodendrocyte precursor cells (OPCs) into mature oligodendrocytes, which produce new myelin. The drug works by blocking M1 muscarinic receptors, which are found on OPCs near MS lesions with ongoing inflammation.
Preclinical studies in a mouse model of MS demonstrated that PIPE-307 increased myelin repair and reduced physical disability compared to untreated animals. Phase 1 trials in healthy volunteers indicated that the therapy was generally safe and well-tolerated at multiple doses.
Management Commentary
"We are pleased to reach this significant milestone for the PIPE-307 VISTA trial ahead of schedule," said Stephen Huhn, MD, Chief Medical Officer at Contineum Therapeutics. "The trial is designed to show evidence of remyelination as a potentially first-in-class and differentiated therapy for RRMS patients. We believe that PIPE-307 could represent the next evolution in the treatment paradigm for RRMS. We are grateful for the VISTA trial investigators, patients and their families, and we look forward to sharing topline data from this trial."
PIPE-307 is being developed under a global license and development agreement between Contineum and Janssen Pharmaceutica NV, a Johnson & Johnson company.
