Contineum Therapeutics Initiates Patient Dosing in Phase 1b Chronic Pain Trial of PIPE-791
Contineum Therapeutics (NASDAQ: CTNM) has initiated patient dosing in a Phase 1b trial for PIPE-791, a novel brain penetrant small molecule antagonist targeting chronic pain treatment. The randomized, double-blind, placebo-controlled, crossover trial will evaluate the drug's safety, tolerability, and pain reduction effectiveness.
The study focuses on chronic pain associated with osteoarthritis (OA) and low back pain (LBP). The trial will enroll approximately 40 patients across five U.S. sites, with a 28-day treatment duration. Topline data is expected in early 2026.
PIPE-791 works by blocking the lysophosphatidic acid 1 receptor (LPA1R), potentially modifying maladaptive changes in the central nervous system associated with chronic pain. The drug aims to provide a non-opioid treatment alternative for patients suffering from OA and LBP.
Contineum Therapeutics (NASDAQ: CTNM) ha avviato la somministrazione del farmaco ai pazienti in uno studio clinico di Fase 1b per PIPE-791, un nuovo antagonista a piccole molecole in grado di penetrare nel cervello, mirato al trattamento del dolore cronico. Lo studio randomizzato, in doppio cieco, controllato con placebo e crossover valuterà la sicurezza, la tollerabilità e l'efficacia nella riduzione del dolore del farmaco.
La ricerca si concentra sul dolore cronico associato all'osteoartrite (OA) e al dolore lombare (LBP). Il trial recluterà circa 40 pazienti in cinque sedi negli Stati Uniti, con una durata del trattamento di 28 giorni. I dati preliminari sono attesi all'inizio del 2026.
PIPE-791 agisce bloccando il recettore dell'acido lisofosfatidico 1 (LPA1R), modificando potenzialmente i cambiamenti maladattivi nel sistema nervoso centrale associati al dolore cronico. Il farmaco mira a fornire un'alternativa terapeutica non oppioide per i pazienti affetti da OA e LBP.
Contineum Therapeutics (NASDAQ: CTNM) ha iniciado la dosificación de pacientes en un ensayo de Fase 1b para PIPE-791, un nuevo antagonista de pequeñas moléculas que penetra en el cerebro, dirigido al tratamiento del dolor crónico. El ensayo aleatorizado, doble ciego, controlado con placebo y cruzado evaluará la seguridad, tolerabilidad y efectividad en la reducción del dolor del fármaco.
El estudio se centra en el dolor crónico asociado con osteoartritis (OA) y dolor lumbar (LBP). El ensayo inscribirá aproximadamente a 40 pacientes en cinco sitios de EE. UU., con una duración de tratamiento de 28 días. Se esperan datos preliminares a principios de 2026.
PIPE-791 actúa bloqueando el receptor de ácido lisofosfatídico 1 (LPA1R), modificando potencialmente los cambios maladaptativos en el sistema nervioso central asociados con el dolor crónico. El fármaco tiene como objetivo proporcionar una alternativa de tratamiento no opioide para los pacientes que sufren de OA y LBP.
Contineum Therapeutics (NASDAQ: CTNM)는 PIPE-791의 1b상 시험에서 환자 투약을 시작했습니다. 이는 만성 통증 치료를 목표로 하는 새로운 뇌 침투 소분자 길항제입니다. 이 무작위 이중 맹검 위약 대조 교차 시험은 약물의 안전성, 내약성 및 통증 감소 효과를 평가할 것입니다.
이 연구는 골관절염 (OA) 및 요통 (LBP)와 관련된 만성 통증에 초점을 맞추고 있습니다. 이 시험은 미국의 5개 사이트에서 약 40명의 환자를 모집하며, 치료 기간은 28일입니다. 주요 데이터는 2026년 초에 예상됩니다.
PIPE-791은 리소포스파티딕산 1 수용체(LPA1R)를 차단하여 만성 통증과 관련된 중추 신경계의 비적응적 변화를 수정할 수 있습니다. 이 약물은 OA 및 LBP로 고통받는 환자에게 비오피오이드 치료 대안을 제공하는 것을 목표로 합니다.
Contineum Therapeutics (NASDAQ: CTNM) a lancé l'administration du médicament chez les patients dans un essai de Phase 1b pour PIPE-791, un nouvel antagoniste de petites molécules capable de pénétrer dans le cerveau, ciblant le traitement de la douleur chronique. L'essai randomisé, en double aveugle, contrôlé par placebo et croisé évaluera la sécurité, la tolérance et l'efficacité de réduction de la douleur du médicament.
L'étude se concentre sur la douleur chronique associée à l'arthrose (OA) et au mal de dos bas (LBP). L'essai recrutera environ 40 patients dans cinq sites aux États-Unis, avec une durée de traitement de 28 jours. Les données préliminaires sont attendues début 2026.
PIPE-791 agit en bloquant le récepteur de l'acide lysophosphatidique 1 (LPA1R), modifiant potentiellement les changements maladaptatifs dans le système nerveux central associés à la douleur chronique. Le médicament vise à fournir une alternative de traitement non opioïde pour les patients souffrant d'OA et de LBP.
Contineum Therapeutics (NASDAQ: CTNM) hat die Patientenverabreichung in einer Phase-1b-Studie für PIPE-791 eingeleitet, einem neuartigen, das Gehirn durchdringenden kleinen Molekülantagonisten, der auf die Behandlung von chronischen Schmerzen abzielt. Die randomisierte, doppelblinde, placebo-kontrollierte Crossover-Studie wird die Sicherheit, Verträglichkeit und Wirksamkeit der Schmerzreduktion des Medikaments bewerten.
Die Studie konzentriert sich auf chronische Schmerzen, die mit Arthrose (OA) und lumbalen Schmerzen (LBP) verbunden sind. Die Studie wird etwa 40 Patienten an fünf Standorten in den USA einschreiben, mit einer Behandlungsdauer von 28 Tagen. Die ersten Ergebnisse werden Anfang 2026 erwartet.
PIPE-791 wirkt, indem es den Lysophosphatidinsäure-1-Rezeptor (LPA1R) blockiert, wodurch potenziell maladaptive Veränderungen im zentralen Nervensystem, die mit chronischen Schmerzen verbunden sind, modifiziert werden. Das Medikament zielt darauf ab, eine nicht-opioide Behandlungsalternative für Patienten mit OA und LBP zu bieten.
- Phase 1b trial initiation marks important clinical milestone
- Novel non-opioid treatment approach for chronic pain
- Targeting two significant market opportunities: osteoarthritis and low back pain
- Long wait for topline data (early 2026)
- Small trial size of only 40 patients
- Early-stage trial with no efficacy proven yet
Insights
Contineum's initiation of patient dosing in the Phase 1b PIPE-791 trial represents a meaningful early clinical development milestone in the company's chronic pain program. The trial design is methodologically sound - employing randomized, double-blind, placebo-controlled, and crossover elements that should provide reliable preliminary safety and efficacy signals despite the relatively small sample size of 40 patients.
The LPA1 receptor antagonist mechanism represents a novel approach in pain treatment, targeting underlying neurobiological processes rather than simply masking symptoms. By potentially modifying the maladaptive central nervous system changes associated with chronic pain, PIPE-791 aligns with the industry shift toward disease-modifying approaches.
From a development perspective, this exploratory trial is appropriately designed to inform decision-making on advancement of the chronic pain program. The early 2026 data readout timeline positions this as a medium-term catalyst for the company. Investors should understand that while this progression demonstrates pipeline execution, PIPE-791 remains in early-stage development with substantial clinical validation still required.
The chronic pain market represents a substantial opportunity with significant unmet needs, particularly for non-opioid treatments. The conditions targeted by PIPE-791 - osteoarthritis and low back pain - affect millions of patients worldwide and current treatment options often provide inadequate relief with problematic side effect profiles.
PIPE-791's approach of selectively blocking LPA1 receptor activity addresses several key pathophysiological components of chronic pain: demyelination of nerve fibers, neuronal hyperexcitability, and neuroinflammation. This multi-faceted mechanism could potentially provide advantages over treatments targeting single pain pathways.
The brain-penetrant properties of PIPE-791 are particularly relevant, as central sensitization is a critical component of chronic pain that's often inadequately addressed by peripherally-acting analgesics. If successful, a treatment that modifies the underlying neurological adaptations in chronic pain would represent a significant advancement over symptomatic treatments.
While this Phase 1b trial marks important progress, the relatively small sample size and exploratory nature mean it will primarily generate hypotheses for further testing rather than definitive efficacy conclusions.
- Exploratory phase 1b trial will evaluate safety, tolerability and effect on pain intensity
- Topline data readout planned for early 2026
PIPE-791 is being evaluated for the treatment of chronic pain associated with two separate indications, osteoarthritis (OA) and low back pain (LBP). The Company expects to enroll approximately 40 patients at up to five sites in the
“With its unique mechanistic action, PIPE-791 has the potential to modify the maladaptive changes associated with chronic pain,” said Stephen Huhn, Chief Medical Officer, Contineum Therapeutics. “This trial was designed to inform our decision-making on further advancing the chronic pain program. We’re excited for the prospect that PIPE-791 may provide a potentially differentiated, non-opioid treatment option for patients with OA and LBP.”
Chronic pain is often associated with neuropathic symptoms caused by aberrant signaling in the central nervous system (CNS) leading to heightened sensitivity to painful stimuli. LPA1 activation has been shown preclinically to contribute to persistent hypersensitivity, characteristic of neuropathic pain, by promoting the demyelination of nerve fibers, increasing neuronal excitability and enhancing neuroinflammatory responses in the CNS. By selectively blocking LPA1 receptor activity, an LPA1 antagonist could modify the maladaptive changes in the CNS and subsequently reduce pain.
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 in clinical development for relapsing-remitting multiple sclerosis and depression. 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 PIPE-791 Phase 1b chronic pain 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, pursuant to a global license and development agreement, upon Janssen Pharmaceutica NV, a Johnson & Johnson company, to develop PIPE-307 for any other indication other than RRMS and, after completion of the Company’s PIPE-307 Phase 2 VISTA trial, Janssen Pharmaceutica NV’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 Janssen Pharmaceutica NV 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/20250304221906/en/
Steve Kunszabo
Contineum Therapeutics
Senior Director, Investor Relations & Corporate Communications
858-649-1158
skunszabo@contineum-tx.com
Source: Contineum Therapeutics, Inc.
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