Business Wire

NOVAREMED-AG

21.12.2021 15:49:08 CET | Business Wire | Press release

Share
Novaremed’s Non-opioid Lead Compound, NRD.E1, to be Tested in NIH HEAL Initiative Phase 2 Trial for the Treatment of Chronic Pain

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 .

# # #

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

Fra Jiangnans ekkoer til global resonans – Zhejiang Satellite TVs Yue Opera Forårsfestivalgalla genskaber østlig elegance20.2.2026 03:39:00 CET | Pressemeddelelse

På den anden dag af det kinesiske nytår, sammenfaldende med 120-årsjubilæet for Yue-operaens tilblivelse, blev “Yue Rhyme Chinese New Year — 2026 Yue Opera Spring Festival Gala” sendt som planlagt. Gallashowet samlede Kinas førende operamestre, anerkendte sangere og Yue-operaentusiaster fra hele verden for at præsentere en kunstnerisk fest, der kombinerede klassisk arv, tværgenre-fusion og teknologisk udtryk – og viste verden de grænseløse muligheder i østlige traditionelle kunstformer i en moderne kontekst. Zhejiang Satellite TVs virtuelle vært Gu Xiaoyu optrådte sammen med kanalens første robotvært, Lan Xiaotian, og skabte en “cyberscene”, der overskred virkelighedens grænser. Over et dusin traditionelle operafærdigheder blev bragt til live i digitale omgivelser og tilbød et visuelt futuristisk spektakel for et globalt publikum. Gallashowet fremhævede også en kulturel rejse, der krydser bjerge og have. Kunstnere, som i 1959 rejste til den autonome uiguriske region Xinjiang for at stø

Newmont Reports 2025 Mineral Reserves of 118.2 Million Gold Ounces and 12.5 Million Tonnes of Copper19.2.2026 22:08:00 CET | Press release

Newmont Corporation (NYSE: NEM, ASX: NGT, PNGX: NEM) (Newmont or the Company) reported gold Mineral Reserves ("reserves") of 118.2 million attributable ounces at the end of 2025 compared to 134.1 million attributable ounces at the end of 2024, mainly driven by the divestment of assets in 2025. Newmont's portfolio includes significant reserves from other metals, including 12.5 million attributable tonnes of copper reserves and 442 million attributable ounces of silver reserves. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260219894602/en/ Percentage of Gold Reserves by Jurisdiction "In 2025, Newmont maintained its position of having the industry's largest gold reserve base, declaring 118 million ounces of reserves, representing decades of production life with meaningful upside," said Natascha Viljoen, Newmont's President and Chief Executive Officer. "Through the disciplined application of technical rigor in our leading expl

Unveiling NVIDIA Solution Center: Grid Dynamics’ Family of AI Solutions to Cut Costs for Retail and Manufacturing19.2.2026 22:05:00 CET | Press release

Key Takeaways: Enables enterprises to replace high-cost and recurring SaaS licensing fees with high-performance and cost-efficient NVIDIA-based solutions Offerings are derived from Grid Dynamics’ proven customer solutions and leverage NVIDIA’s technology stack Commercially deployed, with additional customers expressing interest NVIDIA and Grid Dynamics jointly presented these solutions at the National Retail Federation (NRF) conference in January 2026 Learn more in NVIDIA’s published blog Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (Grid Dynamics), a premier AI transformation partner for the Fortune 1000, today announced the launch of its NVIDIA Solution Center. This suite of ready-to-deploy AI applications helps retail and manufacturing enterprises move away from costly, recurring SaaS licenses and subscription fees toward high-performance, NVIDIA-powered solutions. Learn more by reading NVIDIA’s recent announcement. The NVIDIA Solution Center is derived from Grid Dynamics’ proven suc

Rimini Street Announces Fiscal Fourth Quarter and Annual 2025 Financial and Operating Results19.2.2026 22:01:00 CET | Press release

Fourth Quarter and Full Year 2025 Financial Highlights Include:Remaining Performance Obligations (RPO) of $652.9 million, up 11.1% from the prior yearAdjusted Calculated Billings, full year 2025, up 4.2% from the prior yearAdjusted Annualized Recurring Revenue (ARR) up 3.1% from the prior year Rimini Street, Inc., (Nasdaq: RMNI), a global provider of end-to-end enterprise software support, managed services and Agentic AI ERP innovation solutions, and the leading third-party support provider for Oracle, SAP and VMware software, today announced results for the 2025 fourth quarter and fiscal year ended December 31, 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260219293814/en/ Rimini Street Announces Fiscal Fourth Quarter and Annual 2025 Financial and Operating Results “Our fourth quarter results reflect solid execution and continued accelerating sales growth, adjusted for the Oracle PeopleSoft support and services wind

Ares Management Prices European Direct Lending CLO II at Over €300 Million19.2.2026 18:25:00 CET | Press release

Ares Management Corporation (NYSE: ARES) (“Ares”), a leading global alternative investment manager, announced today the pricing of its second European Direct Lending Collateralized Loan Obligation, Ares European Direct Lending CLO II (“EDL CLO II”), at over €300 million. Consistent with the underlying composition of its predecessor, EDL CLO II is a diversified CLO comprised entirely of directly originated and actively managed loans issued by over 70 middle-market companies predominantly based in Western Europe and primarily operating in resilient industries. The instrument is weighted towards senior-secured floating rate loans and will be rated by S&P and KBRA. Ares believes EDL CLO II is among the first multi-currency middle-market CLOs in Europe. “We are pleased to successfully price our second European Direct Lending CLO in less than 12 months as we continue building on our nearly 20 years of corporate direct lending experience in Europe,” said Michael Dennis, Partner and Co-Head of

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye