Basel, Switzerland – Novaremed AG, a clinical-stage biopharmaceutical company, reported the completion of patient visits in its Phase 2b clinical trial evaluating nispomeben for painful DPN. The trial, funded by the National Institutes of Health (NIH), is part of the NIH HEAL Initiative and managed by the HEAL Early Phase Pain Investigation Clinical Network (EPPIC-Net).
The 12-week, placebo-controlled study involved 127 adult and elderly participants with painful DPN. Researchers assessed the efficacy and safety of a once-daily 80mg oral dose of nispomeben compared to a placebo. The primary objective was to determine if nispomeben provided superior pain relief. Secondary objectives included evaluating safety, tolerability, pharmacokinetic properties, and the drug’s effects on sleep and quality of life.
Jessica Robinson-Papp, MD, MS, FAAN, the lead investigator, highlighted the significant unmet need for safe and effective non-addictive treatments for painful DPN, a condition affecting approximately 20% of diabetes patients. She expressed gratitude to the participants and collaborating sites and anticipated the upcoming data analysis.
Camilla Mittelholzer, PhD, Novaremed’s Chief Scientific Officer and Head of R&D, emphasized the importance of the NIH’s support for the trial. She noted that nispomeben was the only oral agent selected for this specific EPPIC-Net protocol. The company is now preparing for the next stages of nispomeben’s development.
Nispomeben, formerly known as NRD.E1 or NRD135S.E1, is an orally administered small molecule with a novel mechanism of action. It is designed to treat chronic pain associated with DPN without binding to opioid receptors. The U.S. Food and Drug Administration (FDA) has granted nispomeben Fast Track designation for this indication.
Previous studies, including Phase 1 trials and a Phase 2a proof-of-concept study, demonstrated clinically meaningful pain reduction and good tolerability. No serious or dose-related adverse events were observed.
The NIH HEAL Initiative aims to address the opioid crisis and chronic pain by developing non-addictive pain therapies. The EPPIC-Net program accelerates the clinical trial process for such treatments.
Painful DPN is a common and debilitating complication of diabetes, affecting millions worldwide. Existing treatments often lack efficacy or are poorly tolerated, creating a significant unmet medical need.
Novaremed is focused on developing innovative non-opioid pain management therapies to address this unmet need, with nispomeben as its lead product. The company is committed to providing alternative options for patients suffering from chronic pain and peripheral neuropathy. Topline data from the Phase 2b trial are anticipated in November 2025.
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