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
Nebex Raises $30M Seed Round Led by GV to Build Market Infrastructure for the Global Space Economy29.6.2026 17:38:00 CEST | Press release
The new funding and banking relationship allow Nebex to scale the market and unlock the commercial space economy. Nebex, the market infrastructure platform for the global space economy, announced a $30M seed investment led by GV (Google Ventures), with participation from other top-tier venture funds. The company also announced a banking relationship with J.P. Morgan. The capital raise and new banking relationship will help Nebex scale its platform and connect sovereign space programs with the founders and companies building new technologies to serve the space industry. "We built Nebex because we've seen firsthand that ambitious space founders struggle to deliver complex sovereign programs due to the lack of capital markets infrastructure that supports revenue and cashflow. This is something that exists in nearly every other industry," said Tejpaul Bhatia, CEO of Nebex. "Support from these organizations gives Nebex the additional leverage and financial infrastructure to build the global
Medisca Enters Its Next Chapter Under Founder Antonio Dos Santos29.6.2026 16:19:00 CEST | Press release
Medisca today announced that Founder and Chairman Antonio Dos Santos has returned to the role of Chief Executive Officer as the company enters its next chapter of growth. For more than 35 years, Dos Santos has helped shape Medisca into a global leader in pharmaceutical compounding. As Chief Executive Officer, he will lead the company's long-term strategy, with a focus on expanding Medisca's global reach, investing in new areas of growth, strengthening strategic partnerships, and continuing to advance the products, services, education, and expertise that healthcare professionals rely on every day. "When I founded Medisca, my vision was to raise the standard of pharmaceutical compounding by bringing pharmaceutical-grade quality to the industry and giving healthcare professionals access to the products, knowledge, and innovation they needed to deliver better patient care," said Antonio Dos Santos, Founder and Chief Executive Officer of Medisca. "That purpose continues to guide us. As we b
The Premier Jumping League (PJL) & McCarthy Jumping Team Announce Landmark Purchase29.6.2026 15:10:00 CEST | Press release
With $50 Million Team Acquisition, McCarthy Jumping Team Becomes First PJL Ownership Group Acquisition illustrates strong investor confidence in the future of professional showjumping as highly anticipated 2027 inaugural season to feature 16 teams competing across 14 international events The Premier Jumping League (PJL) today announced that seasoned trader, investor, and competitive race car driver Jason McCarthy and McCarthy Jumping League LLC acquired the first PJL team in a landmark $50 million acquisition, building on rising momentum for the highly acclaimed professional jumping league. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260629512997/en/ The Premier Jumping League (PJL), photographed by Daniel Benson. The milestone investment represents an unprecedented valuation for a team in a newly established sports competition and underscores the confidence that sophisticated investors are placing in the PJL. The inaugur
InvestEco Sustainable Food Fund IV Holds a Final Close With Total Commitments of C$106M29.6.2026 15:00:00 CEST | Press release
InvestEco Capital is pleased to announce the final close of the InvestEco Sustainable Food Fund IV. This fund will continue InvestEco’s work of investing in high-growth food companies that promote health and sustainability in the food sector. The Fund closed with total commitments of C$106M, the largest InvestEco fund to date. Investors include Farm Credit Canada, Export Development Canada, Business Development Bank of Canada, Fonds de solidarité FTQ, and two Government of Canada Social Finance Fund wholesalers: Boann and Realize Capital Partners. In addition, the Fund received commitments from a number of private investors and family offices. The Fund's investments to date include Humble Snacks, Little Sesame, Mid-Day Squares and Algae Cooking Club. The Fund expects to make a further 6 - 10 investments over the next few years. InvestEco Capital, founded in 2002, is a Toronto-based venture capital firm and impact investor focused on the sustainable food sector. For more information, em
Geoswift and SKUx Announce Strategic Partnership to Develop a First-of-Its-Kind Programmable Stablecoin Commerce Network29.6.2026 14:00:00 CEST | Press release
Bridging digital assets, traditional finance, enterprise treasury, and agentic commerce through global programmable money infrastructure Geoswift and SKUx announced a groundbreaking partnership to develop a next-generation programmable stablecoin commerce network. This strategic collaboration bridges digital assets, traditional finance, and real-world commerce at a global scale, representing a "one-of-one" opportunity by combining Geoswift's global infrastructure with SKUx's specialized item-level controls directly within point-of-sale (POS) systems. While enterprise stablecoin usage continues to accelerate globally, governments, enterprises, payment networks, and AI-driven commerce platforms are increasingly seeking programmable payment infrastructure that can bridge digital assets with real-world commerce. The innovation goes far beyond treasury management or even enabling consumers to spend stablecoins at retail locations. Instead, it unlocks true "programmable money" with embedded
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