Contineum Therapeutics Provides Update on Phase 1b Positron Emission Tomography (PET) Trial of PIPE-791

Business Wire

5 hours ago

SAN DIEGO--(BUSINESS WIRE)--Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced an update on its Phase 1b positron emission tomography (PET) trial of PIPE-791, a selective antagonist of the lysophosphatidic acid 1 (LPA1) receptor. The Company has completed enrollment of the healthy volunteer and progressive multiple sclerosis (PrMS) cohorts of this trial. The screening and enrollment of idiopathic pulmonary fibrosis (IPF) patients to participate in this trial is ongoing.
'In early June, consistent with our protocol, we enrolled two additional PrMS patients to assess PET imaging of the brain,' said Timothy Watkins, M.D., M.Sc., Chief Medical Officer and Head of Development, Contineum Therapeutics. 'While adding these additional patients to the trial has led to a modest delay in reporting our topline data, we believe the enhanced clinical understanding of PIPE-791 in patients is important to the program. This trial builds on our compelling preclinical data and improves our understanding of receptor occupancy in healthy volunteers and patients, helping guide our dose selection in the next stages of clinical development. We now anticipate reporting topline data from these fully enrolled cohorts in the third quarter of 2025.'
The Phase 1b, open label, single-center trial is designed to assess the correlation between pharmacokinetics and LPA1 receptor occupancy using PET imaging in healthy volunteers, as well as IPF and PrMS patients. To date, 12 healthy volunteers and four PrMS patients have participated in this trial. More information on this trial can be found at https://clinicaltrials.gov (NCT06683612).
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. PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and major depressive disorder. 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, those regarding the anticipated timing and results of topline data from the healthy volunteer and PrMS cohorts from the Company's ongoing Phase 1b PET trial; the potential of the Company's Phase 1b PET trial to improve the Company's understanding of target occupancy of PIPE-791 or to guide dose selection for further clinical development, or to predict future clinical outcomes or results; the indications, anticipated benefits of, and market opportunities for its drug candidates; 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 the Company's programs and prospects to be negatively impacted by developments relating to the Company's competitors, including the results of studies or regulatory determinations relating to the Company's 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 relapsing-remitting multiple sclerosis (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 relapsing-remitting multiple sclerosis (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 macroeconomic and market and economic conditions and uncertainty caused by, among other things, geopolitical conditions, tariffs or threatened tariffs, inflation volatility, and military conflict may adversely affect the Company's 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 the Company's periodic filings and in other filings that the Company makes with the Securities and Exchange Commission (SEC) from time to time, which 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.