The National Institutes of Health (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). The trial builds on Phase 2a proof-of-concept study in PDPN, which showed a clinically relevant reduction in patient-reported pain and good tolerability of NRD.E1.
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. 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.
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 study is planned to start in the second quarter of 2022.
“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.”
(Press release / SK)
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