GNT Pharma has successfully completed a Phase III clinical trial for crisdesalazine, a new drug for treating canine cognitive dysfunction syndrome or Alzheimer’s disease.

In the clinical study conducted with 48 companion dogs with severe cognitive dysfunction at 7 veterinary hospitals including Seoul National University Animal Hospital, crisdesalazine-treated group demonstrated outstanding and significant efficacy compared to the placebo group in canine cognitive dysfunction rating scale, the primary outcome measure, as well as in canine dementia scale, the secondary outcome measure. Efficacy was identified both at the 4-week and 8-week treatment in companion dogs that received 5 mg/kg or 10 mg/kg of crisdesalazine. No adverse events were found in relation with the administration of crisdesalazine.

Davis research group at the University of California reported that 28% of companion dogs aged 11~12 and 68% of such dogs aged 15~16 suffer from cognitive dysfunction. As lifespan of companion dogs increases thanks to the advancement in veterinary science and healthcare, their dementia prevalence rate is on the rise. But the increase in companion dogs with dementia is emerging as a serious socio-economic problem due to the unavailability of treatment for dogs with dementia.

Crisdesalazine is a multi-target drug developed to provide strong antioxidant effect and safe anti-inflammatory action to prevent amyloid plaque, neurofibrillary tangle, and neurodegeneration that cause Alzheimer’s disease and companion dog’s dementia. Earlier, scientists at GNT Pharma proved that crisdesalazine reduced amyloid plaques and neuronal death while improving cognitive function in the Alzheimer’s disease mice models.

“Demonstration of safety and outstanding efficacy of crisdesalazine in companion dogs with dementia is a groundbreaking outcome and we recently filed an application for the PCT patent,” said Dr. Jin Hwan Lee, Head of GNT Pharma Animal Healthcare Division.

“We expect to complete its Phase II clinical study in 2~3 years for patients with Alzheimer’s disease,” said Dr. Byoung Joo Gwag, CEO of GNT Pharma and inventor of crisdesalazine. “We plan to submit an application to the Ministry of Food and Drug Safety in the second half year for the clinical study of crisdesalazine for treating Alzheimer’s disease.”