Business Wire

NOVAREMED-AG

Share
Novaremed Announces IND Submitted to U.S. FDA for Phase 2 Study of NRD135S.E1 for the Treatment of Painful Diabetic Peripheral Neuropathy; Also Announces the Appointment of Three New Board Members

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

Novaremed had received initial feedback from the FDA during a Pre-IND meeting held on July 24, 2019. The Phase 2 study, designed as a randomized, double-blind, placebo-controlled study, will enroll patients experiencing neuropathic pain caused by Diabetes Mellitus. Eligible patients will be randomized to receive oral doses of either NRD135S.E1 or placebo once daily for 3 months.

“Submitting this IND is an important next step in the clinical development of NRD135S.E1 for the treatment of PDPN and we are moving rapidly to potentially address a global unmet medical need,” said Sara Mangialaio, M.D., Ph.D., CMO and Head of R&D at Novaremed. “We look forward to launching this Phase 2 study as soon as possible. This study will provide further important information about the safety and efficacy of NRD135S.E1, which was very well tolerated and induced a clinically relevant reduction in pain in the previous Phase 2 Proof of Concept study of 3-week duration.”

The company is currently in discussions with potential investors to raise the necessary funding to support the conduct of the proposed Phase 2 study, as well as prepare for further late-stage development activities of NRD135S.E1.

“Safe and effective therapies are critical to provide patients and physicians with treatment alternatives for PDPN,” said Subhasis Roy, M.Com, MBA, CEO/COO of Novaremed. “The next steps announced today for NRD135S.E1 highlight the result of Novaremed’s many years of pursuit to move a novel non-opioid drug against PDPN as rapidly as possible.”

Novaremed also announced today the appointment of three new members to the company’s board of directors, effective May 14, 2020. Joining the board are Thomas Meier, Ph.D., Benyamin Sidon and Eliahu Kaplan, M.D. These appointments bring Novaremed’s total board membership to six.

Dr. Thomas Meier is a dynamic life sciences entrepreneur who established Santhera Pharmaceuticals (SIX Exchange: SANN) as a successful Biotech/Specialty Pharma company in Switzerland. In the past 20 years he held executive positions (CSO and CEO) and successfully supported or executed mergers, acquisitions, product licensing and turn-around situations. Since 2017 he is member of Santhera’s Board of Directors. He holds a Ph.D. in Biology from the University of Basel and carried out post-doctoral training at the University of Colorado Health Sciences Center (USA) and Biozentrum, University of Basel, where he became group leader and lecturer in neurosciences before joining the industry. He is an internationally recognized scientist with track record in clinical research of orphan diseases (neuromuscular, neuro-ophthalmology). In 2007, he received the BioValley Basel Award for his outstanding contributions to the life sciences in the area.

Mr. Benyanin Sidon is an Investment Advisor at Gefen Biomed Investments, an Israeli public company, investing in Israeli startups with disruptive technologies. He has been active in fund raising and portfolio management activities in Israel over the last three decades. He sits on the board of directors of several portfolio companies of Gefen in Israel and abroad. He has a B.A. in Economics from Tel Aviv University, Israel.

Dr. Eliahu Kaplan is the founder, former board member and CEO of Novaremed Ltd as well as former CEO and Chief Innovator of Novaremed AG. He has more than 30 years of experience in the pharmaceutical industry particularly in oncology drug development. He worked at Farmitalia Carlo Erba in Milan, Italy as Director of Oncology Corporate Medical Department, as Medical Director in Freiburg, Germany as well as in Israel. In addition, between 1994 and 1998, he founded Seneb-Pharma, a consulting firm to consult in the field of R&D of drugs and medical products. Between 2005 and 2006 he was Medical Director (part-time) at Oridion BreathID in Israel.

“We are excited to welcome Thomas, Benny and Eli to our board of directors. They bring decades of leadership in drug development and in business, that are vital to our future operations and strategy,” said Isaac Kobrin, M.D., Chairman of the Board of Novaremed.

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 PDPN. For more information, visit www.novaremed.com .

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

Stressed, anxious, excited – CIOs' state of mind in 2024, according to research from Expereo19.9.2024 10:03:00 CEST | Press release

60% of global respondents say their focus on AI has boosted their personal reputation147% also say their board has unrealistic demands regarding the impact of AI139% felt their job is more stressful or negative because of their added profile1 Technology leaders from large global enterprises are feeling the pressure as AI becomes a major force of innovation and disruption, according to the IDC InfoBrief, commissioned by Expereo, Enterprise Horizons 2024: Technology Leaders’ Priorities on Their Digital Business Journey*, which reveals that 64% of global respondents find it challenging and/or stressful to meet the technology demands of the business, and that AI is a key source of both pressure and opportunity. The paper reveals that AI has raised the profile and expectations of technology leaders at board level – a double-edged sword for many senior technology decision-makers. While 60% of global respondents say their focus on AI has boosted their personal reputation, 47% also say their b

HORNBACH Baumarkt Selects Blue Yonder To Accelerate Its Omni-Channel, Customer-Centric Strategy19.9.2024 09:00:00 CEST | Press release

Leading German DIY retailer will leverage Blue Yonder Commerce microservices to provide customers with innovative “order by, get by” promising and order fulfillment optimization to improve customer satisfaction Today, retail offers a wide range of opportunities. Retailers must consistently focus on the needs of their customers if they want to be successful – even in the future. Tech innovation is accelerating. Consumers want to be free to decide whether they want to shop in the store or via smartphone or computer. Optimally, it should all be connected. Retailers are looking to innovate, add new services, and deliver experiences that consumers love, but they often face a costly and expensive fix because their tech stack was not built for modern experiences with efficiency in mind. That’s why, as a pioneer in innovation and one of the leading DIY retailers in Europe, HORNBACH Baumarkt has selected Blue YonderInventory and Commits Services, part of Blue Yonder Order Management solutions.

Murata Unveils the World’s Smallest Multilayer Ceramic Capacitor with the First 006003-inch Size (0.16mm×0.08mm) Device19.9.2024 08:00:00 CEST | Press release

Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) has expanded its innovative range of multilayer ceramic capacitors (MLCCs) with yet another groundbreaking addition. Exemplifying Murata’s continual commitment for minimization, it has developed the world’s first 006003-inch size (0.16 mm x 0.08 mm) MLCC. This achievement represents a volume ratio approximately 75% lower than the existing smallest product, the 008004-inch size (0.25×0.125mm). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240918232327/en/ [Murata Manufacturing Co., Ltd.] Murata’s world’s first 006003-inch size (0.16 mm x 0.08 mm) MLCC (Photo: Business Wire) In recent years, as electronic devices become more sophisticated and compact, the number of electronic components installed has increased, while simultaneously the space required for installation has been reduced. As electronic devices continue to advance in intelligence, there has been a c

Wolters Kluwer expert to speak at Europe's inaugural Microsoft Fabric Community Conference19.9.2024 08:00:00 CEST | Press release

Simon Hjortsberg to share expertise on AI-driven data analysis at Stockholmsmässan, Sweden, September 24-27, 2024 Wolters Kluwer Tax & Accounting (TAA), a global leader in professional information, software solutions, and services, today announced that Simon Hjortsberg, the company's Manager of Business Intelligence, will be a keynote speaker at Europe's first-ever Microsoft Fabric Community Conference. The anticipated event will take place from September 24 to 27, 2024, at Stockholmsmässan, in Sweden. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240918799017/en/ Simon Hjortsberg, Manager, Business Intelligence, Wolters Kluwer Tax & Accounting (Photo: Business Wire) On Wednesday, September 25, Simon Hjortsberg will deliver a presentation on “Sharing Experiences with Fabric Copilot.” As an experienced Global Senior Business Intelligence Analyst, Hjortsberg will delve into the ways generative AI features are transforming dat

Dfns Wallet Infrastructure Now Available on Temenos Exchange19.9.2024 07:37:00 CEST | Press release

Dfns offers a Wallets-as-a-Service (WaaS) platform that enables organizations to easily create, integrate, and manage digital assets at scale, delivering enhanced wallet security and efficiency for financial institutions and fintech companies. Dfns, a leading provider of wallets-as-a-service (WaaS) solutions, today announced Dfns Wallet Infrastructure is available on Temenos Exchange, the partner ecosystem of integrated fintech solutions. This partnership makes Dfns the first European digital asset infrastructure provider to integrate with Temenos, joining a select group that includes Wyden, Fireblocks, and Taurus. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240918695901/en/ Dfns Wallet Infrastructure Now Available on Temenos Exchange (Graphic: Business Wire) The Dfns Wallet Infrastructure delivers critical business benefits tailored to the needs of institutional finance and banks. By integrating with Temenos, our solutio

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
HiddenA line styled icon from Orion Icon Library.Eye