GNT Pharma "Nellonemdas·Hypothermia Treatment Combination Therapy, Domestic Patent Application"

GNT Pharma announced on the 4th that it has filed a domestic priority patent for the 'combination therapy of Nelenemdas and hypothermia treatment.'

GNT Pharma 'Nellonemdaz'
[Photo by GNT Pharma]

GNT Pharma filed the patent after confirming the brain cell protection, improvement of brain nerve function, and safety of the multi-target new drug 'Nelenemdas' in patients who received hypothermia treatment following the restoration of spontaneous circulation after severe cardiac arrest emergency measures.

When the heart temporarily stops, it is known that about 2 million brain nerve cells die per minute due to the accumulation of glutamate and reactive oxygen species in the brain. Because of this, patients who miss the golden time suffer disabilities or die. The only treatment for cardiac arrest patients is hypothermia therapy, which lowers the patient's body temperature to 32-34 degrees Celsius after cardiopulmonary resuscitation. However, its effect is weak and limited, making the development of appropriate therapeutics urgent.

Nelenemdas was confirmed to safely improve brain nerve function and reduce brain death when combined with hypothermia therapy in a Phase 2 clinical trial involving 105 cardiac arrest patients conducted at five university hospitals including Samsung Medical Center and Chonnam National University Hospital. Among severe, comatose cardiac arrest patients who received high-dose (5250 mg) Nelenemdas within 4 hours after spontaneous circulation was restored by cardiopulmonary resuscitation, the proportion of patients able to live independently without disability after 90 days was 63%, an increase of 22.3 percentage points compared to 40.7% in the placebo group. Accordingly, GNT Pharma explained that it filed a patent for Nelenemdas to protect brain cells and improve brain nerve function not only in cardiac arrest patients receiving hypothermia treatment but also in patients with stroke, spinal cord injury, and neonatal hypoxic-ischemic encephalopathy receiving hypothermia treatment.

Since the efficacy and safety of Nelenemdas were confirmed in the Phase 2 clinical trial, GNT Pharma plans to soon apply for conditional approval under the trade name ‘Zantinel.’

Byungjoo Kwak, CEO of GNT Pharma, said, “Ninety percent of cardiac arrest patients die, and survivors suffer permanent disabilities such as brain damage, but there has been no appropriate therapeutic. Since the safety and efficacy of Nelenemdas have been confirmed, we will promptly apply for conditional approval as an orphan drug for cardiac arrest patients and proceed with Phase 3 clinical trials for global market entry.”