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
Paymentology Raises $175 Million co-led by Apis Partners and Aspirity Partners to Support Next Phase of Growth12.5.2026 09:01:00 CEST | Press release
Paymentology, the leading global issuer-processor, today announced a $175 million investment co-led by Apis Partners (”Apis”), a private equity firm specialising in financial infrastructure and services, and Aspirity Partners (“Aspirity”), a pan-European Private Equity firm focused on Financial Technology & Services and Enterprise Technology & Connectivity Services. The investment will support Paymentology’s continued global expansion, product development and strengthening of its team, as the company builds on strong demand for modern issuer processing on a global scale. The transaction brings together two investors with deep experience in the payments industry and a shared focus on advancing payments infrastructure, united by the view that issuer processing represents one of the most significant opportunities in the sector. For Apis, the investment, made by Apis Growth Fund III1, marks the firm’s 16th payments investment. Both Apis and Aspirity will draw on their deep sector and globa
IQM Launches HPC Integration Service to Accelerate Hybrid Quantum-HPC Adoption12.5.2026 09:00:00 CEST | Press release
IQM Radiance systems now operate as computational nodes inside HPC environments. The hybrid workflows are scheduled and managed alongside CPUs and GPUs by the same workload manager already operational in the world’s top supercomputing centers. The new HPC Integration Service reflects the company’s production quantum model – end-users own the hardware, run it on their infrastructure, and operate it under their control. IQM Quantum Computers today launched HPC Integration Service, a turnkey solution that enables its IQM Radiance quantum computers to operate as a slurm node inside high-performance computing (HPC) environment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260512187465/en/ IQM Radiance quantum computer (right) co-located with classical HPC infrastructure (left) in a data center environment. Using this widely adopted HPC workflow, IQM aims at accelerating adoption of hybrid quantum-classical computing across ente
Visa Flexible Credential Brings More Flexible Ways to Pay to Zilch Cardholders in the UK12.5.2026 09:00:00 CEST | Press release
Visa, Zilch and Thredd collaborate to help issuers deliver a simpler, more flexible card experience for users. Visa, a world leader in digital payments, Zilch and Thredd today announced the introduction of Visa Flexible Credential (VFC) on Zilch cards in the UK, enabling more flexible ways to pay through a single, familiar card experience. Demand for flexible payment experiences continues to grow. Many people no longer think in fixed terms such as debit or credit, instead wanting the ability to choose what works best for a specific purchase in the moment. In the UK, 87% of people surveyed say flexible payment options support their financial or lifestyle goals1. Visa Flexible Credential is designed to support this shift, helping issuers offer more choice through one familiar card that already works at more than 150 million merchant locations worldwide. The new capability allows different payment options to sit behind one card or digital credential, giving cardholders greater choice and
AMP IT Announces New Funding Round to Scale Its Private EV Charging as a Service in Switzerland and Beyond12.5.2026 08:43:00 CEST | Press release
AMP IT, a Geneva-based energy and mobility company, today announced the successful completion of a new funding round to accelerate the deployment of its private EV charging and energy management platform across Switzerland and international markets. Founded in 2021, AMP IT develops, finances, installs, and operates smart EV charging infrastructure for residential buildings, commercial real estate, and corporate fleets. Through its charging-as-a-service model, the company combines infrastructure with its proprietary software, AMP IT Hub, delivering a fully integrated energy solution. The latest funding round, supported notably by the Swiss Technology Fund, brings AMP IT’s total funding to €7 million since inception. The capital will support operational scaling, further development of its software platform, and expansion into selected European markets. “Users are increasingly looking for solutions that are simple, efficient, and affordable which is exactly what we provide,” said Florian
New Data Analyses Presented at Heart Failure 2026 Demonstrate Robust and Consistent Clinical Benefit of Vutrisiran as a First-Line Treatment Option Across ATTR-CM Patient Populations, Including Patients with a High Disease Burden12.5.2026 08:30:00 CEST | Press release
− Reductions in All-Cause Mortality and Recurrent Cardiovascular Events Maintained Across Key Patient Subgroups, Including Patients Taking a Broad Range of Heart Failure Therapies –− Pooled Analysis of Over 25,000 Patient-Years of Experience with TTR-Silencing RNAi Therapies Shows a Consistent Safety Profile, Including No Clinically Meaningful Ocular Effects of Vitamin A Lowering –− DemonsTTRate Study Designed to Generate Long-Term Real-World Evidence in More Than 2,000 Patients with ATTR-CM − Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced new analyses from the HELIOS-B Phase 3 study of vutrisiran in patients with the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM), adding to the growing body of evidence supporting vutrisiran and reinforcing the durability of transthyretin (TTR) knockdown and its well-characterized safety profile. Vutrisiran is the first and only TTR silencer approved for ATTR-
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