GNT Pharma announced on the 18th that it has received approval from the Animal and Plant Quarantine Agency for a clinical trial plan (IND) to expand the indication of Jedacure, a currently marketed treatment for canine cognitive dysfunction syndrome, to include canine epilepsy.
This clinical trial will be conducted on about 40 dogs suffering from epilepsy that experience repeated seizures despite taking anticonvulsants. The dogs will receive the active ingredient of Jedacure, crisdesalazine, once daily at a low dose (2.5 mg/kg) or high dose (5 mg/kg) for 8 weeks under double-blind conditions along with anticonvulsants. The frequency of seizures before and after administration will be compared to verify efficacy and safety. Professor Hwayoung Yoon of the Department of Internal Medicine at Seoul National University College of Veterinary Medicine will serve as the principal investigator, with participation from more than six veterinary colleges and animal hospitals.
Jinhwan Lee, head of the Animal Health Business Division at GNT Pharma, said, “Crisdesalazine inhibits reactive oxygen species and inflammation in animal models, preventing the death of hippocampal neurons. Through this clinical trial, we aim to verify the seizure-suppressing effect of crisdesalazine.”
Epilepsy is a disorder characterized by temporary hyperactivity of brain neurons, causing repeated seizures, loss of consciousness, and behavioral changes. It affects 0.5 to 5% of dogs as well as humans. In humans, it is the third most common brain disorder after stroke and dementia, occurring in about 4 to 10 people per 1,000.
Jedacure is the first synthetic new animal drug approved by the Animal and Plant Quarantine Agency in Korea and was launched in 2021. It is currently sold in about 1,900 animal hospitals nationwide, and its safety and cognitive dysfunction improvement effects have been verified through a three-year post-marketing surveillance.
Byungjoo Kwak, CEO of GNT Pharma, said, “Crisdesalazine is a dual-target drug with strong antioxidant and safe anti-inflammatory effects, making it a platform new drug applicable to various diseases. Additional indications such as canine meningitis have been continuously confirmed through post-marketing surveillance, and we will expand indications in line with global market entry.”
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