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
Alpaca Raises $150 Million at a $1.15B Valuation to Build the Global Standard for Brokerage Infrastructure14.1.2026 13:00:00 CET | Press release
Alpaca appoints lead investor Drive Capital’s Co-Founder and Partner Chris Olsen to its board Alpaca, a global leader in brokerage infrastructure whose APIs empower partners like Kraken, SBI Securities, and Dime!, today announced it has raised a $150 million Series D led by Drive Capital that values the company at $1.15 billion. Drive Capital’s Co-Founder and Partner, Chris Olsen, will join Alpaca’s Board of Directors as part of the investment. The company also secured a $40 million line of credit, further strengthening its balance sheet as it continues to expand globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114225657/en/ Alpaca Raises $150 Million at a $1.15B Valuation to Build the Global Standard for Brokerage Infrastructure “Our mission is to open financial services to everyone on the planet,” said Yoshi Yokokawa, Co-Founder and CEO of Alpaca. “We are building the global standard for brokerage infrastructure
Sixth Street Raises €3.75 Billion for Third European Direct Lending Fund14.1.2026 12:30:00 CET | Press release
Sixth Street SLE III Hits Hard Cap, Reflecting Long-Term Strength as One of Europe’s Leading Private Capital Platforms Sixth Street, a leading global investment firm, today announced the final close of Sixth Street Specialty Lending Europe III (“SLE III” or “the Fund”), at its hard cap with €3.75 billion in total equity commitments. SLE III is Sixth Street’s third and largest dedicated fund focused on providing financing solutions for companies across Europe. The total investable capital for SLE III is expected to be approximately €7 billion, including anticipated leverage. “We are grateful to our long-term capital partners for their trust and commitment to our strategy as we continue to support European businesses at any point in their lifecycle, offering customized capital solutions delivered with speed and certainty,” said Michael Griffin, Co-Head of Sixth Street Global Direct Lending and Head of Europe Direct Lending. “This is a significant milestone for our European Direct Lending
500 Global Announces Promotion of Mei Chel Tan to Global Managing Partner14.1.2026 12:00:00 CET | Press release
Appointment reflects expanding demand for entrepreneurial ecosystem development and AI readiness across emerging markets. 500 Global, one of the world’s most active venture capital firms1, today announced the promotion of Mei Chel Tan to Global Managing Partner. Her appointment reflects both her leadership in expanding 500 Global’s footprint across high-growth regions and the accelerating AI transformation that is positioning nascent and emerging markets as central drivers of the next era of global growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114209489/en/ 500 Global announces promotion of Mei Chel Tan Mei Chel joined 500 Global in 2016 and was appointed Partner in 2023. Over the past decade, she has helped shape the firm’s expansion across Asia, Europe, Middle East and Africa — architecting the launch of early Asian investment funds and vehicles, leading market-entry strategies, developing national ecosystem di
Usercentrics Acquires MCP Manager to Bring Consent and Trust to AI14.1.2026 11:15:00 CET | Press release
Extending Privacy‑Led Marketing from websites and apps into AI workflows, so businesses can scale AI with much-needed oversight, auditability, and control Usercentrics, the global leader in Privacy-Led Marketing solutions, announced today it has acquired MCP Manager, a next-generation governance platform for the Model Context Protocol (MCP), built by a team with deep expertise in AI infrastructure. The acquisition makes Usercentrics the first major global market leader in data privacy solutions to extend consent and data guardrails into AI-driven workflows. The combined platform will deliver a unified Privacy-Led Marketing Suite that manages consent, preferences, and data governance across websites, apps, internal systems, and consumer-facing AI agents. Because these agents increasingly shape personalization and customer engagement, extending consent into real-time, model-driven interactions applies the same rigor that exists at data collection. This keeps experiences transparent, trus
Blue Shift Report Highlights Systemic Vulnerabilities Caused by the Hidden Cost of AI14.1.2026 10:00:00 CET | Press release
Arthur D. Little’s Blue Shift institute has published its latest report, AI’s Hidden Dependencies. This in-depth report, involving more than 50 experts, explores AI’s resource dependencies and the consequent direct systemic vulnerabilities for businesses and lays out strategic actions in response. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114966898/en/ Arthur D. Little’s Blue Shift Institute has published its latest report, AI’s Hidden Dependencies With AI’s adoption and usage expected to remain on its growth trajectory, so is its strain on resources. The report notably identifies three main areas of dependency: Environmental impacts, including emissions due to AI’s heavy energy usage and the manufacture of related hardware Energy supply, including increased electricity demand and strain on the grid Compute infrastructure, including supply chain choke points and dependencies on dominant providers As AI is now becomin
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