R&D Towards better quality of life, GNT Pharma

Pipeline

Global New Drug Development Pipeline

NELONEMDAZ Nelonemdaz / Drug for stroke

Overview
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  • Nelonemdaz is the first "multi-target" neuroprotection drug designed to reduce brain damage after stroke or cardiac arrest.
  • Pharmacological action: (1) Inhibition of NMDA receptor subtype NR2B activity (2) Removal of free radicals (antioxidant)
  • Unlike non-selective NMDA receptor inhibitors, nelonemdaz is a proven safe drug that does not cause adverse drug effects such as psychoses in normal people and stroke patients.
  • Verification of safety and efficacy in the phase II clinical study (SONIC) in South Korea with 209 stroke patients undergoing a standard surgery to remove a blood clot.
  • Verification of safety and efficacy in the phase II clinical study (ENIS) in China with 238 stroke patients receiving thrombolytics.
Indications
  • Stroke
  • Cardiac Arrest
  • Traumatic Brain Injury & Traumatic Spinal Cord Injury
  • Burn Injuries
Comparison Safety and Efficacy of Nelonemdaz and clinical trial drugs for stroke
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Type of stroke Nelonemdaz NMDA antagonists Antioxidants
Treatment Time Window in vivo Severe tMCAO 8 hour Less than 1 hour 2-4 hour
Mild tMCAO 48 hour ND
(Not Determined)
Permanent MCAO 4 hour
Forebrain ischemia 24 hour
Safety in human Phase I for Healthy Subjects
Phase II for Stroke
*Safe up to 6,000mg(IV) SAE
at target doses
SAE at target doses
(e.g. edaravone)
Two Phase I Studies
165 subjects in US & China
Two Phase II Studies
447 patients in China & SK
Efficacy in human Ischemic Stroke alone ND All failed All failed except
edaravone in Japan
Ischemic stroke with thrombolytics Beneficial effects in PII (N=238)
PIII ongoing
Ischemic stroke with endovascular thrombectomy Promising beneficial effects in PII SOINC (N=209) Nerinetide little beneficial effects in PIII (N=1105) ND
PIII RODIN ongoing
Cardiac Arrest with ROSC PII AWAKE (N=78 at present) ND ND
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