Contineum Therapeutics has initiated a Phase 1b positron emission tomography (PET) trial for PIPE-791, a novel brain-penetrant, small molecule antagonist of the lysophosphatidic acid 1 receptor (LPA1R). This open-label, single-center trial aims to correlate pharmacokinetics with receptor occupancy in healthy volunteers, as well as patients with idiopathic pulmonary fibrosis (IPF) and progressive multiple sclerosis (PrMS), with topline data anticipated in Q2 2025. The trial will use a PET tracer of the LPA1 receptor to evaluate receptor occupancy in the brain and lungs.

This trial holds significant implications for the potential treatment of IPF and PrMS. Currently, treatment options for both conditions remain limited, with many patients experiencing disease progression despite existing therapies. PIPE-791 offers a novel mechanism of action by targeting the LPA1 receptor, which plays a role in fibrosis and neuroinflammation, the key drivers of IPF and PrMS, respectively. Demonstrating target engagement in these specific disease settings could pave the way for a new therapeutic approach, potentially addressing unmet needs for patients suffering from these debilitating conditions.

The Phase 1b trial is designed to establish a crucial link between the drug’s pharmacokinetics (how the body processes the drug) and its pharmacodynamics (how the drug affects the body). Specifically, it will measure how the concentration of PIPE-791 in the body relates to the occupancy of LPA1 receptors in the brain and lungs. This information will be essential for determining the optimal dose of PIPE-791 for future efficacy trials in IPF and PrMS. Successful demonstration of target engagement through receptor occupancy in patients with these diseases will further validate the therapeutic potential of PIPE-791 and inform the design of subsequent clinical trials.

The outcome of this Phase 1b trial will be a critical inflection point for Contineum Therapeutics and the development of PIPE-791. Positive results demonstrating a clear PK/PD relationship and target engagement in the disease setting would significantly de-risk the program and bolster confidence in its potential to become a first-in-class treatment for both IPF and PrMS. This data will be crucial in guiding the dose selection for future Phase 2 trials and potentially accelerating the development timeline of this promising drug candidate. It could also attract further investment and partnerships, positioning Contineum as a key player in the development of novel therapies for these underserved patient populations. Ultimately, the success of this trial could bring a much-needed new treatment option to patients suffering from IPF and PrMS.

Source link: http://www.businesswire.com/news/home/20241216396391/en/Contineum-Therapeutics-Initiates-Patient-Dosing-in-Phase-1b-Positron-Emission-Tomography-PET-Trial-of-PIPE-791

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.