Business Wire

Novaremed Announces U.S. FDA Approval of IND Application to Initiate Phase 2 Clinical Study of NRD135S.E1 for the Treatment of Painful Diabetic Peripheral Neuropathy

Share

Novaremed AG (Novaremed), a clinical-stage Swiss biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to initiate its US-based Phase 2 clinical study of the novel drug candidate, NRD135S.E1, for the treatment of Painful Diabetic Peripheral Neuropathy (PDPN).

The randomized, double-blind, placebo-controlled, multi-center study will have the primary objective of demonstrating the superiority of NRD135S.E1 over placebo in relieving PDPN in patients after 3 months of treatment.

“The acceptance of our IND is a major milestone in the clinical development of NRD135S.E1 for the treatment of PDPN,” said Sara Mangialaio, M.D., Ph.D., CMO and Head of R&D at Novaremed. “NRD135S.E1 may offer a much-needed non-opioid new treatment option to patients suffering from the disease and improve their quality of life substantially.”

“With the IND clearance from FDA, we are one step closer in the development of NRD135S.E1 to benefit millions of patients suffering from this debilitating disease,” said Subhasis Roy, M.Com, MBA, CEO/COO of Novaremed.

Novaremed is currently in discussions with potential investors to raise the necessary funding to initiate the Phase 2 clinical study and prepare for further late-stage development activities of NRD135S.E1.

Notes to the Editor:

About Novaremed

Novaremed Ltd, a wholly owned subsidiary of Novaremed AG was founded in 2008 in Israel and Novaremed AG was founded in 2017 in Switzerland. Novaremed Ltd is developing NRD135S.E1, an orally active non-opioid small molecule with a novel mechanism of action against PDPN. In a Phase 2 Proof of Concept study, NRD135S.E1 showed clinically relevant reduction in patient-reported pain and an excellent safety and tolerability profile. Novaremed Ltd is currently preparing to conduct a Phase 2 study in USA.

Contact information

For further information about Novaremed, please contact:
Subhasis Roy, CEO/COO
Tel: +41 79 2075715
Email: subhasis.roy@novaremed.com
www.novaremed.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

PCI Pharma Services Introduces First-of-its-Kind Digital Platform to Provide Clients with Real-Time Supply Chain Data and Analytics28.9.2020 13:00:00 EESTPress release

PCI Pharma Services (PCI), a leading pharmaceutical and biopharmaceutical global outsourcing solutions provider today announced the launch of pci | bridge, an innovative digital platform that will give customers immediate visibility into their clinical and commercial supply chain, and provide instantaneous data and insights to inform decision-making. Created using an agile development process whereby key clients collaborated and provided input, PCI built an industry-leading digital interface that delivers greater transparency to clients – saving time and resources to ultimately help bring life-changing therapies to patients faster. The launch of pci | bridge is one of many initiatives that PCI has undertaken to incorporate digital transformation as core to its business strategy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200928005059/en/ pci | bridge digital platform logo (Photo: Business Wire) “At PCI, we are always loo

L&T Technology Services Selected to Support Tenneco DRiV™ Ride Performance Division28.9.2020 12:10:00 EESTPress release

L&T Technology Services Limited (BSE: 540115, NSE: LTTS), a global leading pure-play engineering services company, today announced that it has been selected to provide engineering services for Tenneco’s DRiV original equipment (OE) Ride Control business group. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200928005232/en/ LTTS will be setting up a HUB Development Center which will focus on shared Engineering Services for DRiV. (Photo: Business Wire) LTTS will set-up a HUB Development Center to provide DRiV with additional engineering capacity in conventional damper and component development. The HUB Development Center will also provide a hybrid, unified engineering business model for supporting established domains such as mechanical, product lifecycle management (PLM) and digital engineering. LTTS will also work with DRiV to modernize and upgrade engineering tools and create a global benchmarking framework for product lifec

MILAN AIRPORTS MALPENSA & LINATE FIRST IN ITALY TO DEPLOY ECAC STANDARD 3 CABIN BAGGAGE SCREENING SYSTEMS WITH SMITHS DETECTION28.9.2020 12:00:00 EESTPress release

Smiths Detection today announced that it has been awarded a contract by SEA Group to support the upgrade of Malpensa and Linate Airports, two of the three international airports in Milan, to the highest security standard for cabin baggage in the industry - ECAC EDS CB C3. As part of the implementation, up to 18 advanced Computed Tomography (CT) screening systems — HI-SCAN 6040 CTiX — will be installed at Milano Malpensa Airport Terminal 1 along with up to 10 more at Milano Linate Airport. Besides providing advanced explosives detection with low false alarm rates, the CT technology allows electronic devices and liquids to remain in bags. SEA Group also selected Smiths Detection’s HI-SCAN 6040 CTiX carry-on baggage scanners to help protect the health of travellers by reducing the number of trays required during security screening and minimising points of contact at security lanes. “As key gateways to the rest of the world for Milan, our priority for Malpensa and Linate airports is to pro

PDI Releases International Cloud-Based Logistics Solution for the Fuel Supply Chain28.9.2020 11:00:00 EESTPress release

PDI (www.pdisoftware.com), a global provider of enterprise software solutions to the convenience retail, wholesale petroleum and logistics industries, announced the release of PDI Logistics Cloud international. The company’s holistic logistics software was specifically designed for the fuel supply chain and helps fuel retail, mineral oil, wholesale and hauler companies gain the end-to-end visibility they need to optimize their operations. Logistics Cloud builds on PDI’s heritage of bringing innovative products to the market and enables digital transformation by leveraging the latest technology. Its use of Big Data, IoT, and sophisticated algorithms enable better compartment allocation, automation and forecasting. The software’s robust capabilities—including advanced planning and dispatching, mobile tools, forecasting, telematics, compliance, and analytics—allows businesses to scale, future-proof their operations, and quickly adapt to dynamic market conditions. The solution will allow c

NTT Com Demonstration Test to Link GAIA-X Platform’s “IDS Connector” Technology and SDPF Based on Data Trust®28.9.2020 09:00:00 EESTPress release

NTT Communications Corporation (NTT Com), the ICT solutions and international communications business within the NTT Group (TOKYO:9432), announced today that beginning October 1 it will collaborate with the International Data Spaces Association (IDSA)1 in a demonstration test as the first phase of contributing to the development of a secure, global data-management platform2 that assures interoperability between data platforms built and managed in countries worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200927005006/en/ The test environment image (Graphic: Business Wire) The test environment for sharing highly confidential data securely will include IDS Connectors3, the core technology of GAIA-X4, a federated data infrastructure for Europe, and NTT Com’s Things Cloud® IoT platform and Smart Data Platform (SDPF)5, the later incorporating Data Trust®6 policies. The demonstration, in addition to assessing the practica

Shin-Etsu Chemical Has Developed an Epoch-making Type of Molding Silicone Rubber That Does Not Require Post Cure28.9.2020 09:00:00 EESTPress release

In addition to its already being marketed liquid silicone rubber form, Shin-Etsu Chemical Co., Ltd. (Head Office: Tokyo, President, Yasuhiko Saitoh) has now developed a molding silicone rubber that also does not require post cure in its millable form. Shin-Etsu is the first in the industry to have developed a millable (high consistency) type* of silicone rubber that does not require a post cure. Shin-Etsu succeeded in developing this breakthrough product by making use of the unique technology that Shin-Etsu Chemical has cultivated over a long period of years. In the existing molding method for millable-type silicone rubber, after the initial press cure of the silicone molding is performed, a post cure is carried out in order to drive off the residues that are left within the molded product as a result of the vulcanization agent used in rubber molding as well as the low-molecular siloxane. Compared to the existing product, the new silicone rubber molding product that Shin-Etsu has devel

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