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Novaremed announces that it has raised CHF 4.4 million Phase 2b study planned for lead compound NRD.E1 in diabetic neuropathic pain

Press Release

Novaremed announces that it has raised CHF 4.4 million Phase 2b study planned for lead compound NRD.E1 in diabetic neuropathic pain

Basel/Switzerland, April 17, 2018 – Novaremed AG, a newly incorporated Swiss clinical-stage biopharmaceutical company, announced today that it has successfully raised CHF 4.44 million from private investors. The funds will be used to prepare for a Phase 2b clinical study of its lead compound, NRD.E1, a novel, first-in-class, small molecule for patients suffering from diabetic neuropathic pain (DNP).

NRD.E1 showed efficacy in studies in multiple pre-clinical pain models. Top-line data from the recently concluded placebo-controlled, randomized, Phase 2a (proof of concept) study in 88 patients suffering from DNP showed dose-related, clinically relevant reductions in pain intensity reported by patients. The study, carried out in 10 centers in Israel, helped to identify suitable doses for further clinical evaluation. NRD.E1 was safe and well tolerated over 3 weeks at three doses of up to 150 mg/day, the highest dose used in the study.

Eli Kaplan, MD, Founder and Chief Executive Officer of Novaremed AG, commented: “I am very proud that Novaremed’s lead compound has found strong support in the investor community. In the past years, we have generated a strong set of pre-clinical and clinical data that support a very attractive target profile for this allosteric modulator of Lyn Kinase.”

Dr. Kaplan continued: “The compound – patent-protected in major markets worldwide at least until 2032 – showed tolerability comparable to placebo at doses significantly higher than the therapeutic doses chosen for the next Phase 2b study.”

Novaremed AG is currently planning to publish the full data of the proof of concept study in a peer-reviewed medical journal in 2019.

With the CHF 4.44 million raised, the company will prepare for a Phase 2b clinical study, which will include patients in Europe and the United States.

Novaremed AG is initiating a new financing round targeting institutional investors to raise CHF 25 million for the execution of the Phase 2b clinical study, preparing for a Phase 3 clinical study and initiating life-cycle management.

Dr. Kaplan commented: “Novaremed was originally founded in 2008 in Israel. In the early stages of the company, Israel provided a very good base to conduct basic pre-clinical research and carrying out the proof of concept study in DNP patients with NRD.E1. Now, with clinical development starting on a global level in 2019, Basel is one of the best places worldwide to rapidly gain access to high-quality staff and services.”

Contact

Dr. Eli Kaplan, CEO
+41 61 3179326 eli.kaplan@novaremed.com

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Notes to the Editor:

About diabetic neuropathic pain (DNP)

Diabetes (Type 1 and Type 2) is the leading cause for neuropathy.1 Up to 20% of diabetic patients suffers from DNP2 and two-third of those – more than 15 million patients - experience chronic, debilitating pain that substantially impairs quality of life. The efficacy of available treatments is limited and associated with many adverse effects and drug to drug interactions.

1. Snyder, MJ; Gibbs, LM; Lindsay, TJ: “Treating Painful Diabetic Peripheral Neuropathy: An Update”. American Family Physician. 94 (3): 227–34, 2016

2. van Hecke O. Et al; Pain 2014, 155: 654-662

About NRD.E1

NRD.E1 is a small, once daily, orally available molecule, first synthesized in 2009. NRD.E1 has been shown to be an allosteric modulator of Lyn Kinase and is first in class. It is currently being developed for the treatment of DNP. The recently concluded 3-week, placebo-controlled, randomized Phase 2a proof of concept clinical study in 88 patients suffering from DNP showed clinically relevant reduction in patient-reported pain. NRD.E1 was well tolerated at all doses studied on the Phase 2a study.

About Novaremed

Novaremed Ltd. was founded in 2008 in Israel. In early 2018, the clinical-stage biopharmaceutical company was incorporated in Switzerland as Novaremed AG to gain rapid access to highly qualified staff and services required for rapid clinical development on a global scale. Besides evaluation of its lead compound NRD.E1 in DNP, further indications will be explored as part of a comprehensive life-cycle management, supported by efficacy demonstrated in multiple animal models of pain and other indications.

About the management of Novaremed

Dr. Eli Kaplan is the Chief Executive and Founder of Novaremed Ltd. He practiced medicine in Switzerland. He also has industry experience in the field of oncology within Farmitalia Carlo Erbain in Italy (Milan) and Germany (Freiburg). Dr. Kaplan obtained his medical degree from the University of Bologna, Italy.

The company’s staff in Basel includes Dr. Sara Mangialaio, MD, as Head of Research and Development, Maurizio Rainisio, as Head of Biometry and Subhasis Roy as Chief Operating Officer.

Dr. Mangialaio was previously Therapeutic Area Head at Actelion. She has more than 15 years of experience in the pharmaceutical industry, including Novartis. After completing her medical degree at the University of Milan, Dr. Mangialaio obtained a PhD in Immunology at the University of Strasbourg.

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Maurizio Rainisio was previously Head of Global Biometry at Actelion (until 2010) when he founded AbaNovus. AbaNovus provides consultancy and services in the field of methodology and statistics for clinical studies. He has more than 40 years of experience in the pharmaceutical industry, including Ciba Geigy, Roche and SFR.

Subhasis Roy was previously Managing Partner of Sirius Healthcare Partners, a healthcare advisory boutique. He has over 23 years of bulge bracket Investment Banking and healthcare advisory experience. He has an MBA in Finance from Duke University, NC, USA and Masters’ and Bachelors’ degrees in Commerce from University of Mumbai, India.

Liat Hochman has been the Head of Operations at Novaremed since 2011. Based in Israel, Mrs. Hochman has more than 20 years of experience working in the field of clinical research, including establishing and managing the Israeli affiliate of an international CRO. Mrs. Hochman has a Master of Science degree in microbiology from Tel Aviv University.

Michal Freud-Silverberg has been the Clinical Operations Manager at Novaremed since 2014. Based in Israel, Michael Freud-Silverberg has more than 20 years of experience working in the field of clinical research and has a PhD degree in Biochemistry from Bar-Ilan University.

About the Board of Novaremed

Harry Welten, MBA, Independent Chairman. Over the last 17 years, Harry Welten was Chief Financial Officer of both public as well as venture capital financed biotech companies. During that time he has raised more than CHF 320 million through IPO, venture capital, M&A as well as debt offerings. He serves on the board of several biotechnology companies in Switzerland and the USA and has an MBA (hons.) from Columbia University, New York.

Eli Kaplan, MD. (see under Management)

Uvi Brand. Uvi Brand is the chairperson of the Board of Directors of Gefen Biomed Investments Ltd., an Israeli public company and she is its controlling shareholder. Mrs. Brand is a holder of a BA in political science and manages an occupational clinic in the Israel Electric Corporation. Mrs. Brand is an Investment Advisor at Gefen Investments, an Israeli investment fund targeting Israeli startups with disruptive technologies.

Siak Khim Tan, MD. Dr. Khim Tan is practicing medicine (dermatology) in Singapore. He is an investor in several biotechnology companies, including Novaremed. Dr. Khim Tan obtained his medical degree from the University of Malaya, Kuala Lumpur, Malaysia.

Isaac Kobrin, MD. Dr. Kobrin was Head of Clinical Development at Actelion for twelve years, followed by a year as Chief Medical Officer at Actelion. He currently serves on the boards of several biotechnology companies. Dr. Kobrin obtained his medical degree from Hadassah Hospital in Jerusalem.

Perry Molinoff, MD. Dr. Molinoff was formerly Professor and Chairman of Pharmacology at the University of Pennsylvania. He also served as Vice President of Neuroscience Drug Discovery at Bristol Meyers Squibb. He obtained his medical degree from Harvard University in Boston. Dr. Molinoff’s background includes more than thirty years of experience in both the academic and industrial sectors. He has served on the board of both publically traded and private companies.

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Isaac KobrinNovaremed