Novaremed’s Non-opioid Lead Compound, NRD.E1, to be Tested in NIH HEAL Initiative Phase 2 Trial for the Treatment of Chronic Pain
21.12.2021 17:47:00 EET | Business Wire | Press release
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.”
About NRD.E1
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.
Reference:
[1] 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 NIH, NIH-HEAL and EPPIC-Net
The US National Institutes of Health (NIH), the largest biomedical research agency in the world, has established the NIH HEAL Initiative® to address the opioid crisis. HEAL programs include those focused on identifying, developing, and testing new non-addictive pain therapies. The EPPIC-Net (Early Phase Pain Investigation Clinical Network) is part of the NIH HEAL Initiative and seeks to enhance the treatment of acute and chronic pain and reduce reliance on opioids by accelerating early-phase clinical trials of non-addictive treatments for pain. For more information: https://heal.nih.gov
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.
About Novaremed
Novaremed AG, a privately held clinical-stage biopharmaceutical company, is developing a pipeline of innovative medications for chronic pain management to address the high unmet medical need for better pain relief and as an alternative to opioids. Its lead product is NRD.E1, an orally active non-opioid small molecule with a novel mechanism of action, has FDA Fast Track Designation and IND-approval to proceed with a Phase 2b clinical trial for the treatment of painful diabetic peripheral neuropathy (PDPN). The earlier stage pipeline addressing chronic pain includes the development candidates MP-101 (Phase 2 stage), and MP-103 (preclinical stage), targeting the unmet medical need of prevention and treatment of chemotherapy-induced peripheral neuropathy (CIPN). Currently, over 80% or about 3.1 million cancer patients receiving neurotoxic chemotherapy develop CIPN, which is a leading cause for therapy reduction and/or discontinuation, as well as having a significant impact on patients’ quality of life.
Novaremed Ltd (Israel) and Metys Pharmaceuticals AG (Switzerland) are fully owned subsidiaries of Novaremed AG, domiciled in Basel (Switzerland). For more information: www.novaremed.com.
# # #
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211221005476/en/
Contact information
Mark Altmeyer, Executive Member of the Board
mark.altmeyer@novaremed.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
The LYCRA Company to Eliminate More than $1.2 Billion of Debt through Prepackaged Restructuring Process, Positioning Business for Long-Term Financial Stability and Growth17.3.2026 09:51:00 EET | Press release
The LYCRA Company, LLC (“LYCRA” or “the Company”), a global leader in developing fiber and technology solutions for the apparel and personal care industries, announced today that it has entered into a restructuring support agreement (“RSA”) with the overwhelming majority of its creditors to eliminate approximately $1.2 billion of long-term debt and establish a sustainable capital structure that will recapitalize the Company and position it for long-term financial stability and growth. The RSA has overwhelming support from holders of the Company’s senior secured term loan, 16.000% Senior Secured Notes, and 7.500% Senior Secured Notes, who have agreed to vote in favor of a prepackaged plan of reorganization (the “Prepackaged Plan”). To implement the Prepackaged Plan, the Company and certain of its affiliates, have filed a voluntary prepackaged Chapter 11 case in the U.S. Bankruptcy Court for the Southern District of Texas. The Prepackaged Plan reflects a consensual agreement reached over
EIG’s MidOcean Energy Announces Initial Equity Raise of $1.2 billion Versus $1.0 billion Cover17.3.2026 09:26:00 EET | Press release
MidOcean Energy (“MidOcean” or the “Company”), a liquefied natural gas (LNG) company formed and managed by EIG, today announced an equity capital raise of more than $1.2 billion. This equity raise includes: a $500 million commitment from Idemitsu Kosan, a highly respected global energy company with a long-standing presence across the energy value chain; and additional commitments of $790 million from both new and existing investors. This represents a significant milestone in MidOcean’s capital formation program and reflects continued interest from both new and existing investors in the Company’s strategy to seek to build a diversified, resilient, long-life global LNG platform. There is significant further momentum from additional investors currently in documentation. MidOcean will continue to raise capital, with a cumulative target of up to $2 billion from new investors. The Company has received substantial interest from investors seeking long-term exposure to the LNG sector, supported
RS2 Launches “Beyond by RS2” to Power the Next Generation of European Fintech17.3.2026 09:00:00 EET | Press release
RS2, a Tier-1 global provider of payment processing infrastructure and technology solutions, today announced the launch of Beyond by RS2, a new digital payments brand designed to help fintech companies, platforms, and payment providers rapidly launch card issuing and payment acceptance services across Europe. Built on RS2’s globally proven BankWORKS platform, Beyond by RS2 offers fintechs a comprehensive sponsored issuer and acquiring program, enabling partners to issue cards and process payments without needing their own banking license or direct card scheme membership. The program leverages RS2’s Electronic Money Institution (EMI) license in Germany and its principal membership with Visa and Mastercard, allowing fintech partners to operate under RS2’s regulated infrastructure while maintaining their own customer experience and brand. “Beyond by RS2 represents a major step in our strategy to enable innovation in payments,” said Radi El Haj, CEO, RS2. “Fintechs today want to build powe
H2SITE Appoints Javier Cavada as New Chairman of the Board of Directors17.3.2026 08:00:00 EET | Press release
H2SITE, a technology company delivering hydrogen production and separation solutions, announces the appointment of Javier Cavada as the new Chairman of the Board of Directors. Javier joins H2SITE at a strategic phase of accelerated industrial deployment and scale-up of its hydrogen solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260316654723/en/ With more than 25 years of international leadership in the energy and industrial sectors, Javier brings extensive experience in industrialising complex technologies, building high-performance organisations, and scaling large-scale energy platforms. He currently serves as President and Chief Executive Officer of Mitsubishi Power EMEA. His track record also includes serving as CEO and President of Highview Power, as well as spending 17 years at Wärtsilä Corporation, where he held senior executive roles including President of the Energy division and a member of the global Exec
AMWC 2026: Galderma Showcases Category‑leading Innovation With a Comprehensive Portfolio and Holistic, Future‑focused Aesthetic Strategies17.3.2026 08:00:00 EET | Press release
Galderma (SIX: GALD) will present nine abstracts at the Aesthetic & Anti‑Aging Medicine (AMWC) World Congress 2026 in Monaco, showcasing innovative and robust scientific data across its aesthetics portfolio, alongside three symposia, and multiple Masterclasses and Meet‑the‑Expert sessions, all highlighting the expanding benefits of Sculptra, Relfydess and the Restylane range.1-9 This comprehensive scientific presence reflects Galderma’s holistic, trend‑led approach to innovation, and its commitment to addressing emerging needs such as menopause‑related skin changes, the growing interest in regenerative treatments, and the rising demand for body injectables. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260316497387/en/ “Patients’ needs are changing faster than ever, whether that’s navigating the skin changes associated with menopause, seeking regenerative benefits, or looking for aesthetic harmony beyond the face. The data
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom