NOVAREMED-AG
23.6.2022 15:03:10 CEST | Business Wire | Press release
Novaremed AG, a privately held clinical-stage biopharmaceutical company focused on innovative non-opioid treatment options for chronic pain management announces the simultaneous publication of data from three Phase 1 studies in Clinical Pharmacology in Drug Development and one Phase 2a, placebo-controlled, dose-finding, proof of concept study in European Journal of Pain with the Company’s lead investigational drug candidate NRD.E1, an innovative non-opioid therapy for painful diabetic peripheral neuropathy.
“We are delighted with the publication of our Phase 1 and Phase 2a studies which collectively demonstrate the drug candidate’s potential as an innovative non-opioid treatment option for patients with chronic pain,” said Eva Tiecke, PhD, Chief Scientific Officer and Head of R&D of Novaremed and lead author of both publications. “In the Phase 2a proof of concept study, the primary endpoint showed a clinically relevant placebo-corrected treatment effect in pain reductions at 40 and 150 mg/day of 0.82 Numerical Rating Scale points, p = 0.034 and 0.66, p= 0.061, respectively, though it narrowly missed the pre-specified value of p = 0.016 due to multiplicity. Overall, the study showed robust results given the consistent performance across multiple endpoints. Based on the data now published in peer-reviewed journals, we are encouraged about the potential of NRD.E1 to address the high unmet medical need for a non-opioid agent to treat chronic pain.”
In three Phase 1 studies NRD.E1 was well tolerated as single dose up to 1200 mg and repeated doses of 300 mg/day for five consecutive days. The studies revealed dose-dependent absorption, small increased exposure to NRD.E1 at peak when administered with food and no relevant accumulation after oral administration. The Phase 2a study was a randomized, double-blind, placebo-controlled, dose-finding, proof-of-concept study in 88 patients with PDPN. The study investigated NRD.E1 at 10, 40, or 150 mg/day or placebo over a 3-week treatment period. Primary, pre-specified secondary and post-hoc secondary endpoints analyses consistently demonstrate a clinically meaningful reduction in pain. NRD.E1 was safe and well tolerated.
References:
[1] Tiecke E., Rainisio M., Guentert T., Müller S., Hochman L., Kaplan E., Mangialaio S. (2022). First-in-human single-ascending-dose, multiple-dose and food interaction studies of NRD.E1, an innovative non-opioid therapy for painful diabetic peripheral neuropathy. Clinical Pharmacology in Drug Development (CPDD) (https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.1103 ).
[2] Tiecke E., Rainisio M., Eisenberg E., Wainstein J., Kaplan E., Silverberg M., Hochman L., Mangialaio S. (2022) NRD.E1, an innovative non-opioid therapy for painful diabetic peripheral neuropathy – a randomized proof of concept study. European Journal of Pain (https://onlinelibrary.wiley.com/doi/10.1002/ejp.1989 ).
About NRD.E1
and the treatment of chronic pain
NRD.E1, an orally active small molecule with a novel mechanism of action and patent protection until 2040, is Novaremed's lead compound currently being developed to treat PDPN.
On the basis of the results now published, NRD.E1 was selected by the NIH as the only oral agent to be included in the NIH-HEAL (Help End Long-term Addiction) program. The NIH will sponsor and execute by the and conducted by EPPIC-Net (Early Phase Pain Investigation Clinical Network) a 12-week, double-blind, placebo-controlled Phase 2b study in patients with moderate to severe PDPN in the US. Novaremed has an open IND and received Fast Track Designation from the FDA for NRD.E1.
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 (early clinical development stage), and MP-103 (preclinical stage), targeting the unmet medical need of prevention and treatment of chemotherapy-induced peripheral neuropathy (CIPN). For more information: www.novaremed.com
.
Read the full press release at www.novaremed.com or click here .
View source version on businesswire.com: https://www.businesswire.com/news/home/20220623005585/en/
Link:
About Business Wire
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
European Wealth Firms Build Private Markets Capability Faster Than They Communicate It, Peregrine Report Finds20.10.2026 10:15:00 CEST | Press release
Capability outpaces communication: 73% of the 30 firms show visible private markets engagement, yet only 40% have a dedicated landing page explaining it to clients Swiss private banks set the benchmark: 70% maintain dedicated private markets destinations, led by Julius Baer, UBP, Pictet and Lombard Odier Visibility is concentrated: five firms generate half of all wealth management media coverage, and alternatives just 7% Europe's leading wealth managers have built genuine private markets capability but most have yet to explain it to the clients they built it for, according to The Wealth 30, a new report from Peregrine Communications. The study analyses how 30 leading UK and European wealth managers and private banks position private markets. It concludes that communication, not product, is now the biggest barrier to differentiation in the wealth channel. Capability outpaces explanation 73% of the Wealth 30 engage in private markets yet only 40% operate a dedicated landing page explaini
Infobip and Yamaha Power Conversational Customer Engagement in Indonesia’s Automotive Sector20.10.2026 10:00:00 CEST | Press release
Global AI-first cloud communications platform Infobip strengthens its collaboration with Yamaha Indonesia Motor Manufacturing (YIMM) to transform customer engagement through WhatsApp-powered conversational experiences designed to drive stronger personalization and faster customer interactions. As Indonesia’s consumers increasingly adopt digital-first purchasing behaviors, Yamaha Indonesia is evolving how it connects with customers across the buying journey. Today’s motorcycle buyers often research products through Yamaha’s social media, websites, and video reviews on YouTube before visiting dealerships, raising expectations for brands to deliver fast, seamless, and highly personalized communication. For more than two years, Infobip has supported Yamaha Indonesia in building connected customer engagement strategies that integrate WhatsApp across the company’s wider digital ecosystem, including its websites, social media platforms, and customer touchpoints. The collaboration reflects the
BRG Survey Finds 71% of Competition Lawyers Say Global Antitrust Policies Grew More Fragmented over Past Year20.10.2026 09:00:00 CEST | Press release
BRG's inaugural Global Antitrust & Competition Report surveys 155 senior attorneys across 15 countries, mapping a new era of enforcement shaped by expanding priorities and mounting political stakes. Global antitrust enforcement is pulling apart along national lines, with 71% of senior competition attorneys reporting that policy became more fragmented across jurisdictions over the past 12 months, according to BRG’s inaugural Global Antitrust & Competition Report. Nearly four in five (78%) also cite cross-border antitrust requirements as a significant or recurring challenge. The report draws on a survey of 155 senior antitrust and competition attorneys across the U.S., Europe and Asia-Pacific (APAC) and in-depth interviews with 18 leading lawyers. It also finds that about 60% of respondents expect antitrust enforcement to expand in scope and intensity over the next 12 months. “Domestic politics and geopolitical considerations increasingly influence the application of competition law acro
Finsei Selects Thredd to Power New Debit Offering20.10.2026 09:00:00 CEST | Press release
Partnership brings scalable payment processing, digital wallet capabilities and advanced fraud controls to integrated business finance platform Thredd, the AI-first issuer processing platform, today announced a new partnership with Finsei, a London-based payments company, to power the processing infrastructure behind Finsei’s new Mastercard debit offering. The partnership reflects a shared focus on simplifying an increasingly complex payments environment. Businesses operating across markets often rely on multiple providers to manage accounts, payments, foreign exchange, cards and expenses. Finsei is designed to bring those capabilities together, while Thredd provides the underlying payment technology and infrastructure needed to deliver a secure, digital-first debit experience at scale. At launch, physical and virtual cards will be available, followed by both Apple Pay and Google Pay. “Businesses increasingly expect their financial tools to work together rather than operate as a collec
Murata Develops World’s Smallest 008004-inch Size (0.25mm × 0.125mm) NTC Thermistor for Space-Constrained Temperature Sensing20.10.2026 04:00:00 CEST | Press release
Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) announces the development of the world’s smallest* 008004-inch size (0.25mm × 0.125mm) NTC thermistor, the NCU01 series. Compared with Murata’s previous smallest 01005-inch size (0.4mm × 0.2mm) product, the new series reduces mounting area by approximately 60% while achieving equivalent temperature-sensing performance, with resistance tolerance of ±1% and B-constant tolerance of ±1%. Its ultra-compact size enables temperature sensing to be positioned in increasingly restricted spaces and closer to heat-generating components, supporting more accurate and responsive thermal monitoring in smartphones, wearable devices, and other densely integrated electronic devices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019189089/en/ [Murata Manufacturing Co., Ltd.] World’s smallest 008004-inch size (0.25mm × 0.125mm) NTC thermistor Murata plans to begin sample shipm
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