Contineum Therapeutics Initiates Patient Dosing in Phase 1b Positron Emission Tomography (PET) Trial of PIPE-791
Contineum Therapeutics (NASDAQ: CTNM) has initiated patient dosing in its Phase 1b PET trial for PIPE-791, a novel brain penetrant small molecule antagonist targeting the LPA1 receptor. The open-label, single-center trial aims to evaluate receptor occupancy in the brain and lungs of multiple patient cohorts, including healthy volunteers, idiopathic pulmonary fibrosis (IPF), and progressive multiple sclerosis (PrMS) patients.
The study will measure the correlation between pharmacokinetics and receptor occupancy using PET imaging. The company expects to release topline data in the second quarter of 2025. The trial is registered under NCT06683612.
Contineum Therapeutics (NASDAQ: CTNM) ha avviato la somministrazione del farmaco ai pazienti nel suo studio clinico di Fase 1b PET per PIPE-791, un nuovo antagonista a piccola molecola capace di penetrare nel cervello e mirato al recettore LPA1. Lo studio a etichetta aperta e centro unico ha l'obiettivo di valutare l'occupazione del recettore nel cervello e nei polmoni di diversi gruppi di pazienti, compresi volontari sani, pazienti con fibrosi polmonare idiopatica (IPF) e pazienti con sclerosi multipla progressiva (PrMS).
La ricerca misurerà la correlazione tra farmacocinetica e occupazione del recettore utilizzando l'imaging PET. L'azienda prevede di rilasciare i dati preliminari nel secondo trimestre del 2025. Lo studio è registrato con il numero NCT06683612.
Contineum Therapeutics (NASDAQ: CTNM) ha iniciado la dosificación de pacientes en su ensayo clínico de Fase 1b PET para PIPE-791, un nuevo antagonista de molécula pequeña capaz de penetrar en el cerebro y dirigido al receptor LPA1. El ensayo, de etiqueta abierta y centro único, tiene como objetivo evaluar la ocupación del receptor en el cerebro y los pulmones de múltiples cohortes de pacientes, incluyendo voluntarios sanos, pacientes con fibrosis pulmonar idiopática (IPF) y pacientes con esclerosis múltiple progresiva (PrMS).
El estudio medirá la correlación entre farmacocinética y ocupación del receptor utilizando imágenes PET. La empresa espera publicar datos preliminares en el segundo trimestre de 2025. El ensayo está registrado bajo el número NCT06683612.
Contineum Therapeutics (NASDAQ: CTNM)는 PIPE-791, LPA1 수용체를 목표로 하는 새로운 뇌 침투형 소분자 길항제의 Phase 1b PET 시험에서 환자 투약을 시작했습니다. 이 오픈 라벨 단일 센터 시험은 건강한 자원봉사자, 특발성 폐섬유증(IPF) 및 진행성 다발성 경화증(PrMS) 환자들을 포함한 여러 환자 집단의 뇌와 폐에서 수용체 점유를 평가하는 것을 목표로 하고 있습니다.
본 연구는 PET 이미지를 사용하여 약물 동태와 수용체 점유 간의 상관 관계를 측정합니다. 회사는 2025년 2분기에 주요 데이터를 발표할 것으로 예상하고 있습니다. 이 시험은 NCT06683612로 등록되어 있습니다.
Contineum Therapeutics (NASDAQ: CTNM) a lancé la dosification des patients dans son essai clinique de Phase 1b PET pour PIPE-791, un nouvel antagoniste de petite molécule capable de pénétrer dans le cerveau et ciblant le récepteur LPA1. L'essai en ouvert, à centre unique, vise à évaluer l'occupation du récepteur dans le cerveau et les poumons de plusieurs cohortes de patients, y compris des volontaires sains, des patients atteints de fibrose pulmonaire idiopathique (IPF) et des patients souffrant de sclérose en plaques progressive (PrMS).
L'étude mesurera la relation entre la pharmacocinétique et l'occupation du récepteur à l'aide d'images PET. L'entreprise prévoit de publier des données préliminaires au deuxième trimestre de 2025. L'essai est enregistré sous le numéro NCT06683612.
Contineum Therapeutics (NASDAQ: CTNM) hat mit der Patientendosierung in seiner Phase 1b PET-Studie für PIPE-791, einem neuartigen, durch das Gehirn eindringenden kleinen Molekül-Antagonisten, der auf den LPA1-Rezeptor abzielt, begonnen. Die offene, einzentralisierte Studie zielt darauf ab, die Rezeptorbelegung im Gehirn und in der Lunge mehrerer Patientenkohorten, einschließlich gesunder Freiwilliger, Patienten mit idiopathischer Lungenfibrose (IPF) und Patienten mit progredienter Multipler Sklerose (PrMS), zu bewerten.
Die Studie wird die Korrelation zwischen Pharmakokinetik und Rezeptorbelegung mittels PET-Bildgebung messen. Das Unternehmen erwartet, im zweiten Quartal 2025 erste Ergebnisse zu veröffentlichen. Die Studie ist unter NCT06683612 registriert.
- First-in-class treatment potential for both IPF and PrMS
- Trial will establish PK/PD relationship for PIPE-791
- Results will guide dose selection for future trials
- Extended timeline for topline data (Q2 2025)
- Early-stage trial with no efficacy data yet
Insights
This Phase 1b PET trial for PIPE-791 represents a critical early-stage development milestone. PET imaging studies are essential for understanding drug-target interactions and optimizing dosing strategies. The trial's focus on measuring receptor occupancy in both brain and lungs is particularly noteworthy, as it will validate PIPE-791's dual-targeting potential for both IPF and PrMS - two distinct diseases with significant unmet medical needs.
The use of PET imaging to establish PK/PD relationships is a sophisticated approach that could accelerate the drug's development pathway. If successful, this data will be important for designing more efficient later-stage trials. However, with topline data not expected until Q2 2025, investors should recognize this as a long-term catalyst. The trial's inclusion of both healthy volunteers and patients with target diseases will provide comprehensive insights into PIPE-791's biological activity across different populations.
While the initiation of patient dosing is a positive development, investors should note that this is an early-stage trial focused on mechanism validation rather than efficacy. The market opportunity for both IPF and PrMS is substantial, with the global IPF market alone projected to reach
The company's current market cap of
- Phase 1b trial will evaluate receptor occupancy of PIPE-791 in the brain and lungs of patients in multiple cohorts using a PET tracer of the LPA1 receptor
- Topline data readout planned for the second quarter of 2025
The Phase 1b, open label, single-center trial is expected to measure the correlation of pharmacokinetics to receptor occupancy by PET imaging in healthy volunteers, as well as idiopathic pulmonary fibrosis (IPF) and progressive multiple sclerosis (PrMS) patients. Contineum anticipates topline data from the PIPE-791 Phase 1b PET trial in the second quarter of 2025. More information on this trial can be found at https://clinicaltrials.gov (NCT06683612).
“Initiating dosing in this trial brings us closer to a potentially new, first-in-class treatment for IPF and PrMS patients,” said Stephen Huhn, Chief Medical Officer, Contineum Therapeutics. “We expect this trial will establish a pharmacokinetic/pharmacodynamic (PK/PD) link between PIPE-791 and LPA1 receptor occupancy in healthy volunteers, as well as demonstrate target engagement in the disease setting of IPF and PrMS. The results of the Phase 1b PET trial will inform dose selection of our future trials in both indications.”
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, progressive multiple sclerosis and chronic pain, 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 timing of the topline data readout from the PIPE-791 Phase 1b PET trial; whether the results of the Phase 1b PET trial will be predictive of the dose selection for, or results generated in, future clinical trials of PIPE-791; 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 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/20241216396391/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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