NOVAREMED-AG
25.5.2020 18:32:11 CEST | Business Wire | Press release
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 .
View source version on businesswire.com: https://www.businesswire.com/news/home/20200525005248/en/
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
LTM Launches BlueVerse™ RightLogic to Address Cyber Risk in AI Era6.7.2026 11:12:00 CEST | Press release
New assessment and risk assurance framework helps enterprises gain unified visibility, prioritise remediation and scale AI securely LTM, the Business Creativity partner to the world’s largest enterprises, has launched BlueVerse™ RightLogic, a cybersecurity assessment and risk assurance framework designed to help enterprises identify, assess and remediate cyber exposure as they accelerate AI adoption. AI is now capable of autonomously identifying and exploiting vulnerabilities, while exposure across infrastructure, applications and supply chains continue to expand. This has elevated cyber risk from a technology concern to a board-level priority, with enterprises struggling to maintain visibility and respond at the speed of emerging threats. BlueVerse RightLogic addresses this gap by providing a unified, business-aligned view of enterprise exposure and enabling a shift from fragmented, point-in-time assessments to continuous, evidence-led risk management. The framework combines an end-to
Media Release: Financial Worries Rise and Match Health Concerns as Cost-of-Living Pressures Mount in 20266.7.2026 10:00:00 CEST | Press release
Globally, people are united in their top personal worries: Financial and health issues rank at the top in 2026, averaging 13 percentage points ahead of other concerns.Financial pressure is prominent across Europe, rising in France, Germany, and U.K., and emerging as a top concern in newly measured markets, Spain and Switzerland.Allianz published these results in “The Allianz 3am Report 2026,” which surveyed 10,000 people across 10 countries worldwide about what keeps them awake at night.Addressing financial concerns requires accessible, targeted financial and risk education. To support this, Allianz has launched the “Allianz School For Life” learning platform. Households around the world are feeling the strain of the rising cost of living, with financial pressure increasingly shaping everyday choices and long-term confidence. Finances and health are now tied as the top global worries, at 48% each, followed by concerns about the future at 35%, according to consumer surveys in 10 countri
HAZAMA ANDO Becomes an Official Partner in Helical Fusion’s Commercial Fusion Initiative and Signs MoU Toward Construction of the Fusion Pilot Plant6.7.2026 08:40:00 CEST | Press release
A long-established Japanese general contractor will contribute construction expertise to advance Fusion Pilot Plant development toward commercially viable fusion power. Helical Fusion Co., Ltd. (“Helical Fusion”), a Japan-based fusion energy startup developing fusion power plants, and HAZAMA ANDO CORPORATION (“HAZAMA ANDO”), a long-established Japanese general contractor, today announced that HAZAMA ANDO has become an Official Partner in the Helix Program, Helical Fusion’s commercial fusion initiative. The two companies have also signed a memorandum of understanding (“MoU”) to collaborate toward the construction of Helix KANATA, Helical Fusion’s Fusion Pilot Plant targeted for the 2030s. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260706176052/en/ (L-R) Kazuhiko Kuniya (Representative Director and President, HAZAMA ANDO CORPORATION) and Takaya Taguchi (Co-Founder and CEO, Helical Fusion Co., Ltd.) at a press conference in
Sofinnova Partners Announces Myricx Bio Agrees to Be Acquired by Novartis6.7.2026 07:15:00 CEST | Press release
Sofinnova Partners co-led the seed investment in 2019 and has supported the company from founding through to exitThe proposed acquisition combines the oncology expertise of Novartis with Myricx Bio’s novel ADC assets and platform having broad potential across multiple solid tumor typesMyricx Bio's first-in-class NMTi payload platform is designed to improve the therapeutic index of ADCs, offering the potential for more effective and better-tolerated treatment options for cancer patientsThe transaction valued at up to $1.5 billion including $1.1 billion cash upfront Sofinnova Partners, a leading European life sciences venture capital firm, today announced that its portfolio company Myricx Bio (“Myricx”) has reached agreement to be acquired by Novartis, for up to $1.5 billion including $1.1 billion cash upfront plus potential milestone payments. This marks Sofinnova Partners' seventh exit in three years. Myricx Bio is a UK-headquartered transatlantic biotech company focused on the discove
Global New Material International Wins Technology Innovation Best Practice Award at Sino-European ESG Conference6.7.2026 05:59:00 CEST | Press release
Global New Material International Holdings Ltd. has received the Technology Innovation Best Practice Award at the Third Sino-European Corporate ESG Best Practice Conference recently in Mainz, Germany, in recognition of its efforts to advance sustainable development through material innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260705533555/en/ Thorsten Giehler (L), Director of the Economic, Social Development and Employment Division of The German Society for International Cooperation (GIZ), delivered the award to Zhou Fangchao, Executive Director and Vice President of Global New Material International. The annual conference, initiated by the Chinese Consulate General in Frankfurt and jointly organized with Chinese and European partners, recognizes corporate best practices in environmental, social and governance (ESG) performance. This year's event brought together government officials, business leaders and exper
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