Contineum Therapeutics Receives FDA Approval for PIPE-791 IND in Chronic Pain

Contineum Therapeutics, Inc., a clinical-stage biopharmaceutical company listed on NASDAQ under the symbol CTNM, has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for PIPE-791. The drug aims to treat chronic pain associated with osteoarthritis (OA) and low back pain (LBP). PIPE-791 is a novel, brain-penetrant small molecule antagonist of the lysophosphatidic acid 1 receptor (LPA1R).

The exploratory Phase 1b study will be randomized, double-blind, placebo-controlled, and conducted at multiple centers. The trial is expected to initiate in the first quarter of 2025, enrolling around 40 patients across up to five sites. The treatment duration will be 28 days, and Contineum anticipates the topline data to be available in early 2026.

Carmine Stengone, CEO of Contineum Therapeutics, expressed optimism about expanding the clinical development of PIPE-791 to include the potential treatment of chronic pain. According to Stengone, LPA pathways have been implicated in neuropathic pain components in preclinical pain models and clinical biomarker studies. Evaluating PIPE-791 is a step towards potentially offering a non-opioid treatment option for patients suffering from OA and LBP.

Chronic pain is often linked to neuropathic symptoms resulting from abnormal signaling in the central nervous system, which increases sensitivity to painful stimuli. Activation of the LPA1 receptor contributes to persistent hypersensitivity, characteristic of neuropathic pain, by promoting the demyelination of nerve fibers, enhancing neuronal excitability, and increasing neuroinflammatory responses. By selectively blocking the LPA1 receptor activity, an antagonist like PIPE-791 might prevent or reverse the maladaptive changes in the nervous system that maintain chronic pain.

Osteoarthritis, the most common joint disease, is characterized by chronic pain and reduced mobility, affecting about 33 million people in the United States. Current pharmacological treatments for OA pain include non-steroidal anti-inflammatory drugs (NSAIDs), topical agents, antidepressants, and steroid injections.

Low back pain is another prevalent condition, often related to spinal degeneration, nerve compression, and inflammation, impacting approximately 45 million people in the United States. Common treatments for LBP include over-the-counter or prescription NSAIDs, antidepressants, steroid injections, muscle relaxants, and opioids.

With the initiation of the PIPE-791 Phase 1b chronic pain study, Contineum plans to continue its operations funded by its cash, cash equivalents, and marketable securities of $213.9 million as of September 30, 2024, which are expected to last through 2027.

Contineum Therapeutics focuses on developing oral small molecule therapies targeting biological pathways associated with specific clinical impairments in neuroscience, inflammation, and immunology (NI&I) disorders. The company has two drug candidates in clinical trials: PIPE-791 for idiopathic pulmonary fibrosis and progressive multiple sclerosis, and PIPE-307, a selective inhibitor of the M1 receptor for relapsing-remitting multiple sclerosis (RRMS). PIPE-307 is also being developed under a global license with Janssen Pharmaceutica NV, a Johnson & Johnson company, which plans to initiate a Phase 2 trial of PIPE-307 in depression in 2024.

Contineum Therapeutics remains focused on addressing unmet needs in NI&I indications through its pipeline of internally-developed programs.