Background & Aims
The widespread use of opioids to treat acute and chronic pain contributed to the approximately 10.3 million people aged 12 years and older in the United States in 2018 who misused opioids1. The NIH launched the Helping to End Addiction Long-term® (HEAL) Initiative to provide scientific solutions to the?opioid crisis2. Within HEAL, the Early Phase Pain Investigation Clinical Network (EPPIC-Net)3 designs and conducts Phase 2 clinical trials for selected novel and repurposed non-opioid therapeutic “assets” that target pain conditions with high unmet need. Appropriate assets include drugs, biologics, and devices. EPPIC-Net conducts cutting-edge early phase clinical trials across the age and pain condition spectrum of pain therapeutics submitted by industry, academic, and other partners and accepted after rigorous review. EPPIC-Net provides access to a robust clinical trial network with expert infrastructure providing study design, conduct, and analysis at no cost to the applicant.
Methods
EPPIC-Net has the capacity to conduct several simultaneous multi-site studies across a range of pain conditions and therapeutic modalities. Its infrastructure includes a clinical coordinating center, a data coordinating center, and 12 specialized clinical centers across the United States. Assets are selected for study through a three-tiered application/review process. EPPIC-Net resources and clinical trials are provided at no cost to selected applicants.
Painful diabetic peripheral neuropathy (PDPN) is a common pain condition with high unmet therapeutic need. Here we provide updates on EPPIC-Net’s innovative platform protocol, designed for Phase 2 clinical trials of assets targeting PDPN. EPPIC-Net’s PDPN platform protocol provides a common overarching structure that includes both required and optional modules. The required modules provide efficiency and consistency across assets and the optional modules allow asset-specific elements to be incorporated.
Results
EPPIC-Net currently has two funded trials. The first trial (A 24-week study to evaluate the safety and efficacy of CNTX-6970 in subjects with moderate to severe knee osteoarthritis pain) evaluates the safety and efficacy of a novel oral drug for treatment of patients with moderate to severe knee osteoarthritis pain and recently finished enrolling patients.
The second funded trial (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of 80 mg daily of NRD135S.E1 Versus Placebo in Adult and Elderly Participants with Painful Diabetic Peripheral Neuropathy) is of a novel oral small molecule targeting PDPN being studied under the platform protocol, and is currently open to enrollment. EPPIC-Net provides stable infrastructure with the capacity to run multiple, high-quality trials concurrently, and has additional trials currently in development.
Conclusions
EPPIC-Net welcomes applications for assets that target pain conditions lacking adequate treatment. Applications are accepted and reviewed on a rolling basis. Applicants provide clinical-grade asset for the trial and retain asset ownership and intellectual property rights. EPPIC-Net is addressing the opioid crisis through promoting development of non-addictive pain therapeutics. Applications are welcome from industry, academia, and other organizations located worldwide. EPPIC-Net’s structure allows for trials to receive funding decisions and begin clinical trial enrollment in a shorter timeframe than other funding initiatives.
References
1.Center for Behavioral Health Statistics and Quality. (2019). Key Substance Use and Mental Health Indicators in the United States: Results from the 2018 National Survey on Drug Use and Health Substance Abuse and Mental Health Services Administration, Rockville, MD.
2.Baker RG, Koroshetz WJ, Volkow ND. The Helping to End Addiction Long-term (HEAL) Initiative of the National Institutes of Health. JAMA. 2021;326(11):1005–1006. doi:10.1001/jama.2021.13300.
3.Karp, B., Hommer, R., Peters-Lawrence, M., Barnes, J., Wright, C., 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. The Journal of Pain. 2022, 23 (5), https://doi.org/10.1016/j.jpain.2022.03.123.
Presenting Author
Kevin Jones
Poster Authors
Kevin Jones
PhD
National Institutes of Health
Lead Author
Topics
- Treatment/Management: Pharmacology: Non-opioid