Contineum Therapeutics Completes Enrollment in Phase 2 PIPE-307 VISTA Trial for the Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS)
Contineum Therapeutics (NASDAQ: CTNM) has completed enrollment of 168 patients in its Phase 2 PIPE-307 VISTA trial for treating relapsing-remitting multiple sclerosis (RRMS). The trial, designed to assess safety and efficacy, will evaluate multiple clinical and imaging endpoints sensitive to remyelination changes in RRMS patients.
PIPE-307, being developed under a global license agreement with Janssen Pharmaceutica NV, is positioned as a potentially first-in-class M1 receptor antagonist. The Phase 2 study is randomized, double-blind, placebo-controlled, and multi-center. The last patient is expected to complete the trial in Q3 2025, with enrollment completion achieved ahead of schedule in December 2024.
Contineum Therapeutics (NASDAQ: CTNM) ha completato l'arruolamento di 168 pazienti nella sua fase 2 dello studio PIPE-307 VISTA per il trattamento della sclerosi multipla recidivante-remittente (RRMS). Lo studio, progettato per valutare la sicurezza e l'efficacia, esaminerà molteplici endpoint clinici e di imaging sensibili ai cambiamenti nella mielinizzazione nei pazienti con RRMS.
PIPE-307, sviluppato sotto un accordo di licenza globale con Janssen Pharmaceutica NV, è posizionato come un potenziale antagonista del recettore M1 di prima classe. Lo studio di fase 2 è randomizzato, in doppio cieco, controllato con placebo e multicentrico. Si prevede che l'ultimo paziente completi lo studio nel terzo trimestre del 2025, con il completamento dell'arruolamento raggiunto in anticipo a dicembre 2024.
Contineum Therapeutics (NASDAQ: CTNM) ha completado el reclutamiento de 168 pacientes en su ensayo de fase 2 PIPE-307 VISTA para el tratamiento de la esclerosis múltiple recaída-remitente (RRMS). El ensayo, diseñado para evaluar la seguridad y eficacia, evaluará múltiples puntos finales clínicos y de imagen sensibles a los cambios de remielinización en pacientes con RRMS.
PIPE-307, desarrollado bajo un acuerdo de licencia global con Janssen Pharmaceutica NV, se posiciona como un potencial antagonista del receptor M1 de primera clase. El estudio de fase 2 es aleatorizado, doble ciego, controlado con placebo y multicéntrico. Se espera que el último paciente complete el ensayo en el tercer trimestre de 2025, con la finalización del reclutamiento alcanzada antes de lo previsto en diciembre de 2024.
Contineum Therapeutics (NASDAQ: CTNM)은 재발-일시적 다발성 경화증(RRMS) 치료를 위한 2상 PIPE-307 VISTA 임상 시험에 168명의 환자를 등록 완료했습니다.본 시험은 안전성과 효능을 평가하기 위해 설계되었으며, RRMS 환자의 재미엘리네이션 변화에 민감한 여러 임상 및 영상적 평가 지점을 평가할 것입니다.
PIPE-307은 Janssen Pharmaceutica NV와의 글로벌 라이선스 계약에 따라 개발되고 있으며, 잠재적으로 1급 M1 수용체 길항제로 자리잡고 있습니다. 2상 연구는 무작위 이중 맹검, 대조군 대비 및 다중 센터로 진행됩니다. 마지막 환자는 2025년 3분기에 시험을 완료할 것으로 예상되며, 등록 완료는 2024년 12월에 예정보다 앞서 완료되었습니다.
Contineum Therapeutics (NASDAQ: CTNM) a terminé le recrutement de 168 patients pour son essai de phase 2 PIPE-307 VISTA visant à traiter la sclérose en plaques rémittente-récidivante (RRMS). L'essai, conçu pour évaluer la sécurité et l'efficacité, examinera de multiples critères cliniques et d'imagerie sensibles aux changements de remyélinisation chez les patients atteints de RRMS.
PIPE-307, développé sous un accord de licence mondiale avec Janssen Pharmaceutica NV, est positionné comme un antagoniste potentiel du récepteur M1 de première classe. L'étude de phase 2 est randomisée, en double aveugle, contrôlée par placebo et multicentrique. Le dernier patient devrait terminer l'essai au troisième trimestre 2025, avec un achèvement du recrutement réalisé en avance sur le calendrier en décembre 2024.
Contineum Therapeutics (NASDAQ: CTNM) hat die Rekrutierung von 168 Patienten für seine Phase-2-Studie PIPE-307 VISTA zur Behandlung der schubförmig-remittierenden Multiplen Sklerose (RRMS) abgeschlossen. Die Studie, die zur Bewertung der Sicherheit und Wirksamkeit konzipiert wurde, wird zahlreiche klinische und bildgebende Endpunkte untersuchen, die empfindlich auf Remyelinisierungsänderungen bei RRMS-Patienten reagieren.
PIPE-307, das unter einem globalen Lizenzvertrag mit Janssen Pharmaceutica NV entwickelt wird, wird als potenzieller erstklassiger M1-Rezeptor-Antagonist positioniert. Die Phase-2-Studie ist randomisiert, doppelt-blind, placebo-kontrolliert und multizentrisch. Der letzte Patient wird voraussichtlich im dritten Quartal 2025 an der Studie teilnehmen, wobei der Rekrutierungsabschluss vor dem Zeitplan im Dezember 2024 erreicht wurde.
- Early completion of patient enrollment (168 patients) for Phase 2 trial
- Development partnership with major pharmaceutical company (Johnson & Johnson subsidiary)
- Potential first-in-class therapy in RRMS treatment
- Final trial results not expected until Q3 2025
Insights
The completion of enrollment in the Phase 2 PIPE-307 VISTA trial represents a important milestone in multiple sclerosis drug development. The study's focus on 168 RRMS patients with a targeted completion in Q3 2025 is particularly noteworthy. The trial's design as a randomized, double-blind, placebo-controlled study strengthens its scientific validity.
What sets PIPE-307 apart is its novel mechanism as an M1 receptor antagonist targeting remyelination - a groundbreaking approach in MS treatment. Current MS therapies primarily focus on immunomodulation, while PIPE-307's potential to promote myelin repair could address the underlying neurodegeneration. The partnership with Janssen Pharmaceutica NV adds significant credibility and resources to the development program.
For investors, early completion of enrollment indicates strong trial execution and potentially faster time-to-market if successful. However, it's important to note that Phase 2 trials have historically shown about a 30% success rate in neurology and remyelination agents face unique challenges in demonstrating clinical benefit.
This milestone carries substantial market implications for CTNM. With a relatively modest market cap of
The partnership with Johnson & Johnson's Janssen division provides strategic advantages: reduced development costs, validation of the technology and potential commercialization support. Early completion of enrollment typically reduces operational costs and accelerates potential revenue timelines. The Q3 2025 data readout now becomes a critical catalyst for the stock.
For context, similar Phase 2 successes in MS have historically led to valuation increases of 100-300% for biotech companies. However, investors should consider that PIPE-307's novel mechanism of action, while promising, also carries higher development risk compared to traditional MS approaches.
- Targeted enrollment of 168 RRMS patients achieved in December 2024
- The last patient is expected to complete the trial in the third quarter of 2025
The Phase 2, randomized, double-blind, placebo-controlled, multi-center, proof-of-concept trial of PIPE-307 will assess safety and efficacy in RRMS patients. 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. More information on this trial can be found at https://clinicaltrials.gov (NCT06083753).
“We are pleased to reach this significant milestone for the PIPE-307 VISTA trial ahead of schedule,” said Stephen Huhn, Chief Medical Officer, 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 pursuant to a global license and development agreement between Contineum and Janssen Pharmaceutica NV, a Johnson & Johnson company.
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, progressive multiple sclerosis and chronic pain, and PIPE-307, is a selective inhibitor of the M1 receptor for relapsing-remitting multiple sclerosis (RRMS). For more information, please visit www.contineum-tx.com.
Forward-Looking Statements
Certain statements contained in this press release, other than historical information, constitute forward-looking statements within the meaning of the federal securities laws. Forward-looking statements include, but are not limited to, statements regarding the Company’s clinical trial and product development plans and timelines, including, but not limited to, the expected timing of the topline data from the VISTA trial; the indications, anticipated benefits of, and market opportunities for its drug candidates; its cash runway; its business strategies and plans; and the quotations of the Company’s management. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond the Company’s control and may cause its actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties, include, but are not limited to, the following: the Company is heavily dependent on the success of PIPE-791 and PIPE-307, both of which are in the early stages of clinical development, and neither of these drug candidates may progress through clinical development or receive regulatory approval; the results of earlier preclinical studies and clinical trials, including those conducted by third parties, may not be predictive of future results and unexpected adverse side effects or inadequate efficacy of the Company’s drug candidates may limit their development, regulatory approval and/or commercialization; the timing and outcome of research, development and regulatory review is uncertain; clinical trials and preclinical studies may not proceed at the time or in the manner expected, or at all; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; risks associated with reliance on third parties to successfully conduct clinical trials and, in the case of PIPE-307, the Company’s reliance upon Johnson & Johnson to develop PIPE-307 for depression or any other indication other than RRMS and, after completion of the VISTA trial, Johnson and Johnson’s decision, in its sole discretion, whether or not to further develop PIPE-307 for RRMS; the Company has incurred significant operating expenses since inception and it expects that its operating expenses will continue to significantly increase for the foreseeable future; the Company’s license agreement with Johnson & Johnson may not result in the successful development of PIPE-307; the Company may be unable to obtain, maintain and enforce intellectual property protection for its technology and drug candidates; and unstable market and economic conditions and military conflict may adversely affect our business and financial condition and the broader economy and biotechnology industry. Additional risks and uncertainties that could affect the Company’s business, operations and results are included under the captions, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in its most recent filing on Form 10-Q and in other filings that it makes with the SEC from time to time. These documents are available on the Company’s website at www.contineum-tx.com under the Investor section and on the SEC’s website at www.sec.gov. Accordingly, readers should not rely upon forward-looking statements as predictions of future events. Except as required by applicable law, the Company undertakes no obligation to update publicly or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250108107473/en/
Steve Kunszabo
Contineum Therapeutics
Senior Director, Investor Relations & Corporate Communications
858-649-1158
skunszabo@contineum-tx.com
Source: Contineum Therapeutics, Inc.
FAQ
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