Novaremed AG, a clinical-stage Swiss biopharmaceutical company and its fully-owned subsidiary in Israel, Novaremed Ltd. are focused on the development of NRD.E1, an orally active New Chemical Entity (NCE) for the treatment of Neuropathic Pain.
Novaremed Ltd. was founded in Israel in 2008, where it successfully completed a Phase IIa Proof of Concept (PoC) study in Painful Diabetic Peripheral Neuropathic (PDNP).
In 2017, Novaremed AG was incorporated in Basel, Switzerland, which is one of the most important biotech and pharma clusters in Europe to gain access to experienced clinical development staff and investor capital.
Novaremed AG and Novaremed Ltd. are currently preparing to conduct a global Phase IIb study investigating 3 months treatment with NRD.E1 in PDPN in the US. The study design was agreed with the FDA and the IND opened in June 2020.
NRD.E1 is a new chemical entity, that is orally available and being developed for the treatment of Diabetic Neuropathic Pain (DNP). Our Founder, Dr. Eli Kaplan identified and patented the active components of a traditional remedy used in Siberia to treat inflammation and pain.
NRD.E1 has shown efficacy in multiple preclinical models for neuropathic pain (Chung and Streptozotocine). In addition, NRD.E1 has demonstrated a very good safety profile 13-week toxicology studies in rats and dogs.
The mechanism of action of NRD.E1 is different to that of approved pain therapies. NRD.E1 does not bind/interact with the following receptors: opioids, serotonin, GABA, NMDA, sodium channels, calcium channels, cannabinoid, kinases and a large number of additional targets tested. Our working hypothesis is that NRD.E1 is a Lyn Kinase modulator. Lyn Kinase has been shown to be involved in the upregulation of P2X4, a purinergic receptor, critical for pain processing in the Central Nervous System (CNS).
The Phase IIa Proof of Concept (PoC) was a 3-week, placebo-controlled, randomized, multi-center study, conducted in Israel, in 88 DNP patients. The study outcome showed clinically relevant reduction in patient-reported pain. NRD.E1 was safe and well tolerated at all doses up to 150 mg/day.
Besides evaluation of NRD.E1 in DNP, further indications will be explored as part of a comprehensive life-cycle management. Preliminary efficacy has been demonstrated in multiple preclinical models of pain, inflammation and other indications.
Peripheral nerve injury from various etiologies (e.g., diabetic neuropathy, postherpetic neuralgia, neuropathy due to cancer or trauma) may result in chronic and severe intractable pain: Neuropathic Pain (NP). Despite its varied etiologies, NP conditions share certain clinical characteristics: spontaneous, continuous pain, usually of a burning character; hyperalgesia to noxious stimulation or allodynic hypersensitivity to innocuous stimulation (e.g., light touch and cold). Paradoxically, these hyper-sensitivities can occur in areas in which the patient also complains of and demonstrates loss of sensation.
Diabetic polyneuropathy is one of the most frequent complications of diabetes: it develops in 50% of diabetic patients. Up to 20% of patients with diabetic polyneuropathy long-term suffer from Diabetic Neuropathic Pain (DNP) and experience chronic, debilitating NP that substantially impairs quality of life.
Evidence suggests that in DNP, only a few drugs achieve greater than 30% reduction in pain in more than 50% of patients. In addition, many of the currently available drugs are often not well tolerated by the patients, due to their Central Nervous System or Gastrointestinal side effects.
The rapidly increasing prevalence of diabetes and of DNP, as well as the limitations of the available therapies, makes the treatment of DNP one of the strongest unmet medical need of the upcoming years.