Novaremed AG, a privately held clinical-stage biopharmaceutical company, announces a study with the National Institutes of Health (NIH) under which the NIH will sponsor and conduct a clinical Phase 2b study with Novaremed’s lead non-opioid development compound NRD.E1 in the treatment of painful diabetic peripheral neuropathy (PDPN).
After a thorough review by pain experts, Novaremed has received NIH confirmation for funding and execution of a Phase 2b study with NRD.E1 in patients with PDPN. For this phase 2 investigational trial, Novaremed will provide drug supply and EPPIC-Net (Early Phase Pain Investigation Clinical Network), which is part of the NIH HEAL Initiative, will run the study in the United States.
The NIH-supported Phase 2b trial EN21-01, named SERENDIPITY-1, is a 12-week, multicenter, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of NRD.E1 versus placebo in 260 adult and elderly patients with PDNP. The primary efficacy endpoint aims to demonstrate superiority of NRD.E1 compared to placebo in relieving PDPN. The secondary objectives of the study are to evaluate the pharmacokinetics, safety, and tolerability of NRD.E1, and assess several additional endpoints, including the effect of NRD.E1 on sleep and quality-of-life indicators. The study is planned to start in the second quarter of 2022.
“We are delighted about the NIH support for our lead development candidate NRD.E1,” said Isaac Kobrin, MD, Executive Chairman of the Board of Novaremed. “Currently, approved medications for PDPN provide inadequate pain relief and are associated with many intolerable side effects. We view the funding from the NIH as both an acknowledgment of the validity of the efficacy data and the favorable tolerability and safety profile, as demonstrated in the Phase 2a proof-of-concept study, and a recognition of the high unmet medical need for safe and effective therapies for patients with PDPN.”
“Based on clinical data from the proof-of-concept study and its novel mode of action, we believe that NRD.E1 has the potential to offer unique benefits for treating neuropathic pain associated with diabetes while avoiding some of the side effects observed with current therapies, which often limit their use,” said Eva Tiecke, PhD, Chief Scientific Officer and Head of R&D of Novaremed. “We are thankful to the NIH team for advancing the project to this exciting milestone and look forward to continued collaboration to study this compound.”
NRD.E1 (or NRD135S.E1), an orally active small molecule with a novel mechanism of action, is the Company’s lead compound being developed to treat PDPN. The mechanism of action of NRD.E1 is different to that of approved pain therapies as it does not bind to opioid receptors or other known receptors associated with pain. Completed clinical studies with NRD.E1 include Phase 1 studies and a Phase 2a proof-of-concept study (ClinicalTrials.gov identifier: NCT02345291), which was a 3-week, dose-finding, placebo-controlled, randomized, multi-center study in 86 patients with moderate to severe PDPN and compared three doses (10, 40 and 150 mg/day) of NRD.E1 to placebo. Results showed a clinically relevant, dose-related pain reduction and a favorable tolerability profile of NRD.E1 at all tested doses. Moreover, the results suggested similar or greater pain relief, and better tolerability than reported for standard approved therapies. The US FDA approved the IND for the Phase 2b trial and granted Fast Track Designation to NRD.E1 for the treatment of PDPN.
 Tiecke et al., NRD.E1, An Innovative Non-Opioid Therapy for Painful Diabetic Peripheral Neuropathy – A Randomised Proof of Concept Study, submitted to the European Journal of Pain
About peripheral neuropathy and associated neuropathic pain
Peripheral nerve injury from various etiologies may ultimately result in chronic and severe intractable neuropathic pain. Painful diabetic peripheral neuropathy (PDPN) and chemotherapy-induced peripheral neuropathy (CIPN) are frequent complications of diabetes and cancer treatment and represent the most common forms of neuropathic pain with a high unmet medical need. Worldwide, two-thirds or an estimated 8.1 million diabetes patients with PDPN requiring treatment do not obtain substantial pain relief with current therapies. Many of the currently available products for the treatment of chronic neuropathic pain have limited efficacy and are often not well tolerated. The increasing prevalence of diabetes and cancer as well as the limitations of the available therapies make the prevention and treatment of chronic neuropathic pain a condition of high unmet medical need.