NOVAREMED-AG
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
Lone Star Announces Sale of SPX FLOW to ITT Inc.5.12.2025 13:30:00 CET | Press release
Lone Star Funds (“Lone Star”) today announced the signing by an affiliate of Lone Star Fund XI, LP of a definitive agreement to sell SPX FLOW, Inc. (“SPX FLOW”), a leading provider of highly engineered equipment and process technologies for attractive end markets including industrial, health and nutrition, to ITT Inc. (NYSE: ITT) for $4.775 billion in cash and shares of common stock. Based in Charlotte, N.C., SPX FLOW focuses on process technologies delivering mixing, blending, fluid handling, separation, thermal heat transfer and other solutions integral to industrial, health and nutrition markets. The company has operations in more than 25 countries and sales in more than 140 countries. In partnership with Lone Star, SPX FLOW has focused on improving its sales execution and operating platform, while ensuring high quality and innovative product development. The management team has improved the company’s commercial organization and executed growth initiatives to build its presence in e
AmTrust Financial Services and Blackstone Credit & Insurance Close Strategic Transaction and Launch Newly Formed Multinational MGACompany Named ANV Group Holdings Ltd.5.12.2025 13:00:00 CET | Press release
Strategic Transaction Unlocks Value for AmTrust and Positions ANV Group Holdings for Accelerated GrowthFormer AmTrust President Adam Karkowsky Leading ANV Group Holdings as Chairman and CEO AmTrust Financial Services, Inc. (“AmTrust” or the “Company”), a global specialty property casualty insurer, and Blackstone Credit & Insurance (“BXCI”), today announced the closing of a strategic transaction under which AmTrust and funds managed by BXCI have partnered to spin-off certain of AmTrust’s Managing General Agencies (“MGAs”) and fee-based businesses in the U.S., United Kingdom, and Continental Europe, into ANV Group Holdings Ltd. (“ANV”), a newly formed independent company, following receipt of regulatory approvals. AmTrust and ANV have entered into a ten-year capacity agreement through which AmTrust will remain the underwriter for the existing books of business offered through the MGAs. As previously announced on September 15, 2025, the agreement includes seven AmTrust subsidiaries: ANV S
Galderma Opens up New Chapter for Sculptra® with MDR Certification and New Expanded Indication for Body5.12.2025 07:00:00 CET | Press release
Sculptra®, the first proven regenerative biostimulator, has received European Union (EU) Medical Device Regulation (MDR) certification, expanding its current clinical application for the face to include gluteal area, posterior thighs, décolletage, and upper arms1 Studies investigating the efficacy of Sculptra on areas beyond the face show patients experienced progressive improvements in skin quality (including the improvement in cellulite appearance), firmness, lift, projection, and contour Sculptra’s versatility and new indication allow practitioners to shift patient treatment goals beyond rejuvenation toward enhancement, meeting evolving patient needs The certification validates Sculptra’s safety performance, efficacy, and quality, reinforcing Galderma’s commitment to innovation and meeting evolving patient needs Galderma (SIX: GALD), the pure-play dermatology category leader, today announced the certification of Sculptra for body indications in the European Union (EU) following its
Northern Escape Heli-Skiing Takes the Title of “World’s Best Heli-Ski-Operator” for the 4th Year Running5.12.2025 02:40:00 CET | Press release
4x World’s Best Heli-Skiing Operation near Terrace, BC Northern Escape Heli-Skiing (NEH) has been named World’s Best Heli-Ski Operator 2025 by the World Ski Awards, marking its fourth straight victory following years 2022, 2023 and 2024. This recognition places NEH amongst an elite group of ski tourism operators consistently voted best in the world by industry leaders and enthusiasts alike. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251204074550/en/ A four-year run built on reliability NEH operates in British Columbia’s Skeena Mountains, where deep northern snow and vast terrain come together with small-group heli-skiing and heli snowboarding. When helicopters can’t safely fly, NEH has cat skiing readily available as a backup — an exceedingly rare offering in this industry. The operation spans over 833,571 wild acres of alpine bowls, glaciers and old-growth tree skiing. The NEH experience Guests choose from three lodge f
IDE034, a Bispecific ADC Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance5.12.2025 01:00:00 CET | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC). IDEAYA expects to begin patient enrollment in Q1 2026, initially evaluating patients with solid tumors known to express B7H3 and PTK7, including lung, colorectal, head and neck, and ovarian/gynecological cancers. IDE034 is a bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024. The IND clearance marks an important milestone for this licensed program, supporting subsequent clinical development of IDE034, while highlighting Biocytogen’s technical capabilities in bispecific ADC discovery and development. Dr. Yue
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