BASEL, Zwitserland – (BUSINESS WIRE) – Novaremed AG (Novaremed), een Zwitserse biofarmaceutische onderneming in klinische fase, heeft vandaag aangekondigd dat het een Investigational New Drug (IND) -aanvraag heeft ingediend bij de Amerikaanse Food en Drug Administration (FDA) voor de nieuwe kandidaat voor geneesmiddelen (NRD135S.E1) voor de behandeling van Painful Diabetic Peripheral Neuropathy (PDPN) om NRD135S.E1 te evalueren in een fase 2-onderzoek.
Novaremed had de eerste feedback van de FDA ontvangen tijdens een Pre-IND-bijeenkomst op 24 juli 2019. De fase 2-studie, opgezet als een gerandomiseerde, dubbelblinde, placebo-gecontroleerde studie, zal patiënten met neuropathische pijn veroorzaakt door diabetes mellitus inschrijven. Patiënten die in aanmerking komen, worden gerandomiseerd naar orale doses van NRD135S.E1 of placebo eenmaal daags gedurende 3 maanden.
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
BASEL, Switzerland–(BUSINESS WIRE)– 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:
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.
For further information, please contact:
Subhasis Roy, CEO/COO
Tel: +41 79 2075715