Novaremed AG has achieved a critical milestone in its development of nispomeben, a non-opioid treatment for diabetic neuropathy pain, completing the last patient visit in its NIH-funded Phase 2b clinical trial. The 127-patient study represents a significant step forward in addressing the unmet medical need for safe, effective pain management in diabetic peripheral neuropathy.
Trial Design and Objectives
The Phase 2b EN21-01 trial (ClinicalTrials.gov identifier NCT05480228) is a 12-week, multicenter, randomized, double-blind, placebo-controlled study evaluating whether once-daily oral nispomeben 80 mg is superior to placebo in relieving chronic pain among patients with painful diabetic peripheral neuropathy (DPN). The trial also assesses safety, tolerability, pharmacokinetics, and the compound's impact on sleep and quality of life.
"Chronic pain associated within diabetic peripheral neuropathy affects about 20% of diabetes patients and is the most common form of neuropathic pain. Patients with painful DPN are in high unmet need of safe, effective, and non-addictive treatments," commented Jessica Robinson-Papp, MD, MS, FAAN, Lead Primary Investigator and Professor at the Icahn School of Medicine at Mount Sinai.
NIH HEAL Initiative Support
The study is funded by the NIH Helping to End Addiction Long-term Initiative (NIH HEAL Initiative) and conducted by the HEAL Early Phase Pain Investigation Clinical Network (EPPIC-Net). Notably, nispomeben was selected as the only oral agent for inclusion in the EPPIC-Net platform protocol to assess treatments for painful DPN.
"We are pleased that all patient visits have been completed in this important study with nispomeben. The Phase 2b trial is supported by the NIH, which selected nispomeben as the only oral agent for inclusion in the EPPIC-Net platform protocol to assess treatments for painful DPN," said Camilla Mittelholzer, PhD, CSO and Head of R&D at Novaremed.
Drug Profile and Previous Results
Nispomeben (formerly NRD.E1 or NRD135S.E1) is an orally active small molecule with a novel mechanism of action that differs from approved pain therapies. Importantly, it does not bind to opioid receptors or other receptors associated with opioid mode of action. The US FDA has granted Fast Track designation to nispomeben for the treatment of painful DPN.
The current Phase 2b trial builds on promising Phase 2a results that showed clinically relevant placebo-corrected pain reductions in patients with moderate to severe painful DPN over a 3-week treatment period. In the earlier study, nispomeben was well tolerated with no serious, severe, or dose-related adverse events, and no adverse events suggestive of drug abuse, dependence or withdrawal were identified.
Market Need and Patient Impact
Painful DPN represents a significant unmet medical need, affecting an estimated 5-8 million patients in the US, Europe and Japan. According to the company, worldwide, two-thirds of patients suffering from painful DPN do not obtain sufficient pain relief with current therapies. Many currently available products for treating chronic neuropathic pain have limited efficacy and are often not well tolerated.
Next Steps
With the last patient visit completed, database lock and prespecified statistical analyses are the next steps. Topline readout is scheduled for November 2025. The completion of patient visits marks a major milestone for the program as it advances toward potential regulatory submissions and commercialization.
