Pipeline Therapeutics Receives IND Clearance from FDA to Initiate Phase 1 Study of PIPE-791
-Company on track to begin enrolling healthy volunteers in the second half of 2023-
Excerpt from the Press Release:
DIEGO–(BUSINESS WIRE)–Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, today announced that the U.S. Food and Drug Administration (FDA) cleared the company to initiate its Phase 1 clinical trial of PIPE-791 in healthy volunteers. The Company’s wholly owned program, PIPE-791, is a potent, selective and brain-penetrant small molecule antagonist of the lysophosphatidic acid 1 receptor (LPA1). LPA1 is a critical element in bioactive phospholipid signaling, and is a powerful mediator of both nervous system and systemic inflammatory conditions. Specifically, LPA1 inhibition has important therapeutic potential through augmentation of remyelination and mitigation of neuro-inflammation. Multiple sclerosis (MS) is a leading indication for PIPE-791, as there are no currently approved medicines designed to prevent neuronal loss and mitigate clinical disability in MS patients.
“The FDA clearance of PIPE-791’s IND marks another significant milestone for Pipeline and demonstrates our team’s continued focus and commitment to bringing precision therapies to patients with neurological diseases,” said Carmine Stengone, President and CEO of Pipeline. “PIPE-791 is our second clinical program and our first to address both remyelination and neuro-inflammation. We look forward to evaluating our first-in-class approach to LPA1 inhibition with PIPE-791, with the goal to deliver meaningful benefit to individuals with MS, as well as other neurological and systemic diseases.”
Stephen Huhn, M.D., Chief Medical Officer and Senior Vice President of Clinical Development of Pipeline, added, “We are excited to initiate the Phase 1 study of PIPE-791, which is designed to assess the safety and tolerability of PIPE-791 compared to placebo in healthy volunteers. We expect to commence dosing in the second half of 2023.”
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