September 3, 2018
GNT Pharma said Ropesalazine, a drug candidate for Alzheimer’s disease (AD), has shown an outstanding beneficial efficacy in a pilot clinical trial conducted for dogs with cognitive dysfunction syndrome (CDS) or dementia.
CDS is a progressive neurodegenerative disorder of senior dogs and characterized by altered interaction with family, disorientation, sleep/wake cycle changes, increased house soiling, and activity change. There is no cure for the disease.
Ropesalazine is a multi-target drug to prevent both inflammation and free radicals that contribute to nerve cell death, amyloid plaque production, and neurofibrillary tangle formation which are pathological hallmarks of AD.
Ropesalazine was found to attenuate nerve cell death and amyloid plaques as well as inflammation and oxidative stress in transgenic AD mice models. Ropesalazine reduced cognitive deficit in APP/PS1 AD mice at early, moderate, and late stages. The safety of Ropesalazine was proven in human as well as rats and dogs.
GNT Pharma scientists noticed that CDS is accompanied by nerve cell death, amyloid plaques, and neurofibrillary tangles similar to AD, and designed a pilot study to investigate if Ropesalazine would alleviate signs of CDS.
The study was conducted on six companion dogs aged 10 or older that revealed severe cognitive dysfunction scored according to canine cognitive dysfunction rating scale and canine dementia scale. Within 8 weeks following daily oral administration of Ropesalazine, all six dogs returned to the normal range of cognitive function and daily activity.
Dr. Jae Bong Moon, veterinarian and head of Irion Animal Hospital in Seoul who led the study, was excited with the result, saying “The companion dogs failed to recognize their owners before the treatment. It was so amazing to see the dogs that wagged their tails for their owners and cuddled up to them within 8 weeks of Ropesalazine treatment. Ropesalazine appeared to cure CDS.”
Encouraged with promising efficacy of Ropesalazine for CDS, GNT Pharma will move toward the next clinical study for approval of Ropesalazine as a drug for the treatment of CDS. The company assigned Professor Byeong-Teck Kang, director of Chungbuk National University Veterinary Medical Center, as a principal investigator. GNT Pharma plans to complete the clinical trial and launch Ropesalazine for the treatment of CDS in companion animals in 2019.
“We are impressed with such a huge beneficial effect of Ropesalazine for CDS even within 8 weeks of treatment,” GNT Pharma CEO & President Byoung Joo Gwag said, “we will initiate a pivotal phase II study of Ropesalazine for patients with AD next year, hoping to launch Ropesalazine as the first disease-modifying AD therapy within next five years.”