Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, and NINDS (National Institute of Neurological Disorders and Stroke) Early Phase Pain Investigation Clinical Network (EPPIC-Net) Provides Robust Infrastructure for Clinical Trials of Non-addictive Pain Therapeutics

Abstract

In concert with the NIH HEAL Initiative, the NINDS established the Early Phase Pain Investigation Clinical Network (EPPIC-Net) to accelerate clinical trials of non-addictive pharmacologic/non-pharmacologic therapeutics ("assets") for pain conditions of high unmet need. We present EPPIC-Net's accomplishments since opening in Q4 of 2019. In its first year, EPPIC-Net established a robust infrastructure including a Clinical Coordinating Center, Data Coordinating Center, and 12 Specialized Clinical Centers across the US, providing broad outreach to diverse pain populations. For accepted assets, EPPIC-Net delivers a collaborative network of multi-disciplinary pain experts who provide novel early phase clinical trial design, incorporating proof-of-concept testing and biomarker validation, study conduct, and data analysis. NINDS utilizes a unique, rigorous, 3-stage application/review process, with trials funded under NIH's "Other Transactions" Authority. For accepted assets, trials are run by the NIH-funded network, at no cost to asset providers who provide clinical grade asset for the trial. Asset owners retain intellectual property rights to their asset. In its first two years of operation, EPPIC-Net funded clinical trials for three assets. The first trial, focused on painful knee osteoarthritis, is open to enrollment. Start-up activities are underway for the others. The latter two trials will be conducted under an innovative master platform protocol for painful diabetic peripheral neuropathy. The master protocol will run in parallel with clinical trials for additional accepted therapeutics addressing other pain conditions of high unmet need. EPPIC-Net continues to seek innovative, non-addictive investigational therapeutics ready for early phase clinical trials (IND/IDE ready or approved) for ANY pain condition lacking adequate treatment. Proposed therapeutics can include novel drugs, small molecules, biologics, natural products, and devices, as well as repurposed drugs or devices. Applications from academia, industry, and not-for-profit organizations, worldwide, can be submitted at any time and are reviewed on a rolling basis.