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
Samos Energy Acquisition Corporation Announces Pricing of Initial Public Offering10.7.2026 15:32:00 CEST | Press release
Samos Energy Acquisition Corporation (the “Company”) announced today the pricing of its initial public offering (“IPO”) of 20,000,000 units at a price of $10.00 per unit. The units will be listed on the New York Stock Exchange (the “NYSE”) and trade under the ticker symbol “SAMO.U” beginning on July 10, 2026. Each unit consists of one Class A ordinary share and one-half of one redeemable warrant, with each whole warrant entitling the holder thereof to purchase one of the Company’s Class A ordinary shares at an exercise price of $11.50 per share. Once the securities comprising the units begin separate trading, the Class A ordinary shares and warrants are expected to be listed on the NYSE under the symbols “SAMO” and “SAMO.WS,” respectively. Cantor Fitzgerald & Co. is acting as the sole book running manager for the proposed offering. The Company has granted the underwriter a 45-day option to purchase up to an additional 3,000,000 units at the IPO price. The public offering is being made
Onera hPSG® Wins Prestigious Red Dot Product Design Award10.7.2026 15:00:00 CEST | Press release
Onera Health's patch-based home polysomnography solution, Onera hPSG®, was awarded the renowned ‘Red Dot Award: Product Design 2026’ in recognition of the sensors’ innovative design, advanced functionality, and user-centric engineering. Onera Health, a leader in transforming sleep medicine, announces that its innovative product, Onera hPSG®, has been honoured with the prestigious Red Dot Product Design Award for 2026. This international recognition celebrates exceptional design quality and underscores Onera Health's commitment to excellence, creativity, and patient-centric innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260710266668/en/ Onera Health's patch-based home polysomnography solution, Onera hPSG®, wins Prestigious Red Dot Product Design Award 2026. The Red Dot Award, one of the most sought-after seals of quality for good design, attracted thousands of entries from around the globe. Onera hPSG® stood out f
teamLab Biovortex Kyoto Welcomes Over 1 Million Visitors within 9 Months of Opening10.7.2026 09:00:00 CEST | Press release
teamLab Biovortex Kyoto has welcomed over 1 million visitors as of July 6, 2026, 9 months after its grand opening. (*1) These visitors arrived from more than 150 countries and regions. International visitors account for approximately 42% of the total. Many of these international visitors travel from distant countries and regions, including the United States, Australia, Canada, the United Kingdom, and Germany. Approximately 30% of these international visitors purchase their tickets at least 30 days in advance. teamLab Biovortex Kyoto is teamLab's largest museum in Japan, with an average visitor stay of over two and a half hours. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260709913938/en/ teamLab Biovortex Kyoto Welcomes Over 1 Million Visitors within 9 Months of Opening *1 According to ticket purchase data from the official teamLab Biovortex Kyoto website (survey period: October 7, 2025 – July 6, 2026) Visitors Comment (M
Robbyant Launches LingBot-VA 2.0 Built Natively for Embodied AI and Physical World Control10.7.2026 08:48:00 CEST | Press release
Robbyant, an embodied AI company within Ant Group, today announced the release of LingBot-VA 2.0, the industry’s first embodied-native video-action world model. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260709654440/en/ A robot powered by LingBot-VA 2.0 engages in a real-time tabletop air hockey match with a human This release marks a key transition in robotics foundation models, shifting from repurposing digital world models to designing them natively for the physical world. Instead of relying on fine-tuned digital content generation models, LingBot-VA 2.0 is built from scratch to meet the original demands of dynamic modeling, causal prediction, and real-time execution in physical environments. Integrating world models with embodied AI has been one of the major focuses of the AI industry. However, most mainstream approaches rely on video generation models designed for digital content, which are then fine-tuned for robo
SureWerx Appoints Erik Pertot as VP/GM SureWerx EMEA10.7.2026 08:00:00 CEST | Press release
Experienced global PPE leader to strengthen portfolio strategy, operational execution, and growth across SureWerx’s international platform SureWerx, a leading global manufacturer of personal protective equipment, safety products, tools and equipment solutions, today announced the appointment of Erik Pertot as VP/GM SureWerx EMEA. Pertot will report directly to CEO Scott Dowell and will lead growth, manufacturing and M&A activities in Europe across the company’s global portfolio. Erik joins SureWerx with more than 20 years of international leadership experience across engineering, quality, marketing, sales, international supply chain, product management, and general management. He brings deep expertise in the personal protective equipment industry, with a track record of leading complex, compliance-critical programs, managing business transitions, and driving growth across multinational environments. Most recently, Pertot served as Global General Manager for Footwear and Fall Protection
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