Contineum Therapeutics Expands Clinical Development of PIPE-791 With FDA Authorization of Its Investigational New Drug (IND) Application for Chronic Pain
Contineum Therapeutics (NASDAQ: CTNM) received FDA authorization for its IND application for PIPE-791, targeting chronic pain treatment. The company plans to commence a Phase 1b study in Q1 2025 for osteoarthritis and low back pain treatment. The study will be randomized, double-blind, placebo-controlled, involving approximately 40 patients across five sites with a 28-day treatment duration. Topline data is expected in early 2026. PIPE-791 is a novel brain penetrant small molecule antagonist of LPA1R, targeting neuropathic pain components. The company's cash position of $213.9 million is expected to fund operations through 2027.
Contineum Therapeutics (NASDAQ: CTNM) ha ricevuto l'autorizzazione della FDA per la sua domanda di IND per PIPE-791, mirato al trattamento del dolore cronico. L'azienda prevede di avviare uno studio di Fase 1b nel primo trimestre del 2025 per il trattamento dell'osteoartrite e del dolore lombare. Lo studio sarà randomizzato, in doppio cieco e controllato con placebo, coinvolgendo circa 40 pazienti in cinque sedi con una durata del trattamento di 28 giorni. I dati preliminari sono attesi all'inizio del 2026. PIPE-791 è un nuovo antagonista a piccole molecole penetrante nel cervello dell'LPA1R, mirato ai componenti del dolore neuropatico. La posizione finanziaria dell'azienda, pari a 213,9 milioni di dollari, è prevista per coprire le operazioni fino al 2027.
Contineum Therapeutics (NASDAQ: CTNM) recibió la autorización de la FDA para su aplicación IND para PIPE-791, enfocado en el tratamiento del dolor crónico. La compañía planea iniciar un estudio de Fase 1b en el primer trimestre de 2025 para el tratamiento de la osteoartritis y el dolor lumbar. El estudio será aleatorio, doble ciego y controlado con placebo, involucrando aproximadamente a 40 pacientes en cinco sitios con una duración del tratamiento de 28 días. Los datos preliminares se esperan a principios de 2026. PIPE-791 es un nuevo antagonista de pequeñas moléculas que penetra en el cerebro del LPA1R, dirigido a los componentes del dolor neuropático. La posición de efectivo de la compañía de 213.9 millones de dólares se espera que financie las operaciones hasta 2027.
Contineum Therapeutics (NASDAQ: CTNM)는 만성 통증 치료를 목표로 하는 PIPE-791에 대한 IND 신청이 FDA의 승인을 받았습니다. 회사는 2025년 1분기에 골관절염 및 요통 치료를 위한 1b상 연구를 시작할 계획입니다. 이 연구는 무작위 이중 맹검 방식이며, 28일의 치료 기간 동안 5개 장소에서 약 40명의 환자가 참여할 예정입니다. 최초 데이터는 2026년 초에 기대됩니다. PIPE-791은 신경병증 통증 성분을 목표로 하는 LPA1R의 새로운 뇌 침투 소분자 길항제입니다. 회사의 현금 잔액인 2억 1천3백90만 달러는 2027년까지 운영 자금을 지원할 것으로 예상됩니다.
Contineum Therapeutics (NASDAQ: CTNM) a reçu l'autorisation de la FDA pour sa demande IND concernant PIPE-791, visant le traitement de la douleur chronique. L'entreprise prévoit de commencer une étude de Phase 1b au premier trimestre 2025 pour le traitement de l'arthrose et des douleurs lombaires. L'étude sera randomisée, en double aveugle et contrôlée par placebo, impliquant environ 40 patients répartis sur cinq sites avec une durée de traitement de 28 jours. Les données préliminaires sont attendues début 2026. PIPE-791 est un nouvel antagoniste à petites molécules capable de pénétrer dans le cerveau, ciblant les composants de la douleur neuropathique. La position de trésorerie de l'entreprise, s'élevant à 213,9 millions de dollars, devrait financer les opérations jusqu'en 2027.
Contineum Therapeutics (NASDAQ: CTNM) erhielt die Genehmigung der FDA für seinen IND-Antrag für PIPE-791, das auf die Behandlung von chronischen Schmerzen abzielt. Das Unternehmen plant, im ersten Quartal 2025 eine Phase-1b-Studie zur Behandlung von Kniearthrose und Rückenschmerzen zu beginnen. Die Studie wird randomisiert, doppelblind und placebokontrolliert sein und umfasst etwa 40 Patienten an fünf Standorten mit einer Behandlungsdauer von 28 Tagen. Die Hauptdaten werden Anfang 2026 erwartet. PIPE-791 ist ein neuartiger, das Gehirn durchdringender kleiner Molekülantagonist des LPA1R, der auf neuropathische Schmerzkomponenten abzielt. Die finanzielle Lage des Unternehmens von 213,9 Millionen US-Dollar wird voraussichtlich die Betriebsabläufe bis 2027 finanzieren.
- FDA authorization received for IND application
- Strong cash position of $213.9M sufficient until 2027
- Targeting large markets: 33M OA patients and 45M LBP patients in US
- Phase 1b trial won't start until Q1 2025
- Initial data won't be available until early 2026
- Small trial size of only 40 patients
Insights
The FDA's IND authorization for PIPE-791 marks a significant milestone in developing non-opioid pain treatments. The drug's novel mechanism targeting LPA1R could potentially address both neuropathic and inflammatory components of chronic pain, differentiating it from current standard treatments.
The planned Phase 1b study is well-designed with 40 patients across multiple centers, using a robust double-blind, placebo-controlled methodology. The
The addressable market is substantial, with 33 million OA and 45 million LBP patients in the US alone. However, investors should note that meaningful revenue potential is still years away, with initial data not expected until early 2026.
This IND approval represents a strategic expansion of Contineum's pipeline, targeting two substantial markets with significant unmet needs. The company's strong cash position of
The development timeline is relatively extended, with trial initiation in Q1 2025 and data in 2026, suggesting minimal near-term catalysts. However, success in either indication could represent significant commercial potential given the large patient populations and current reliance on NSAIDs and opioids.
- Phase 1b study for the potential treatment of osteoarthritis and low back pain expected to commence in the first quarter of 2025
- Initial data readout planned for early 2026
- Neuropathic component of chronic pain linked to LPA1 activation
The exploratory Phase 1b, randomized, double-blind, placebo-controlled, crossover, multi-center study is expected to begin in the first quarter of 2025. The Company expects to enroll approximately 40 patients at up to five sites, and a treatment duration of 28 days. Contineum anticipates topline data from the PIPE-791 Phase 1b chronic pain study in early 2026.
“We’re pleased to expand PIPE-791 clinical development to include the potential treatment of chronic pain in a limited, exploratory, signal-seeking study,” said Carmine Stengone, CEO, Contineum Therapeutics. “Researchers have shown that LPA pathways have been specifically implicated in the neuropathic components of preclinical pain models and clinical biomarker studies. This is a first step to evaluate how 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 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 (Company research, Ueda 2020). By selectively blocking LPA1 receptor activity, an LPA1 antagonist may prevent or reverse the maladaptive changes in the nervous system that initiate and maintain the chronic pain state.
OA is the most common joint disease characterized by chronic pain and decreased mobility. OA affects approximately 33 million people in
LBP is a common musculoskeletal condition that can be associated with spinal degeneration, nerve compression and inflammation. Low back pain affects approximately 45 million people in
With the addition of the PIPE-791 Phase 1b chronic pain study, the Company continues to expect its cash, cash equivalents and marketable securities of
About Contineum Therapeutics
Contineum Therapeutics (Nasdaq: CTNM) is a clinical stage biopharmaceutical company focused on discovering and developing novel, oral small molecule therapies for NI&I indications with high unmet need. Contineum is focused on targeting biological pathways associated with specific clinical impairments, that Contineum believes, once modulated, may demonstrably impact the course of disease. Contineum has a pipeline of internally-developed programs to address multiple NI&I disorders. Contineum has two drug candidates in clinical trials, PIPE-791, an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis and progressive multiple sclerosis, and PIPE-307, a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis (RRMS). PIPE-307 is being developed pursuant to a global license and development agreement between Contineum and Janssen Pharmaceutica NV, a Johnson & Johnson company, who has also announced plans to initiate a Phase 2 trial of PIPE-307 in depression in 2024. 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 initiation of the PIPE-791 chronic pain study and the timing thereof; the design and goals of the PIPE-791 chronic pain study; the expected timing of the topline data from the PIPE-791 chronic pain study; 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 studies 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 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/20241114778987/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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