YONGIN, South Korea--(BUSINESS WIRE)--GNT Pharma today announced the Korea Animal and Plant Quarantine Agency (APQA) has approved the New Drug Application for GedaCure, a chewable tablet of crisdesalazine, for the treatment of dogs with cognitive dysfunction syndrome (CDS) that suffer from disorientation, altered interactions with family, sleep-wake cycle disturbance, house soiling and changes in activity with aging.

GedaCure is the worlds first multi-target neuroprotection drug for canine cognitive dysfunction syndrome. It is expected to improve the quality of life of aged dogs with CDS and their owners. GNT Pharma plans to launch GedaCure in South Korea and will push ahead in earnest to advance globally for dogs and their family who suffer from CDS.

Like Alzheimers disease (AD), canine CDS is an age-related progressive neurodegenerative disease with a cognitive and behavioral deficit that is accompanied by beta amyloid precipitation, pathological tau, and neuronal death. The prevalence of senior dogs with CDS has been rapidly increasing with the extended lifespan, however, there is no cure for the disease.

Crisdesalazine prevents oxidative stress as a spin trapping agent and inflammation as an inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1), inducible enzymes essential for inflammatory PGE2 production. Crisdesalazine showed considerable effects in 3-D culture and animal models of Alzheimers disease in reducing neuronal death, tauopathy, and amyloid plaques to some extent which are pathological hallmarks of Alzheimers disease.

In a pilot clinical trial for canine CDS, all 6 companion dogs with CDS that received daily oral administration of 10 mg/kg crisdesalazine for 8 weeks showed remarkable symptomatic relief. Even in 4 weeks after administration of crisdesalazine, the dogs re-recognized and wagged their tails to their owners, slept well in the night, and revealed improved activity.

GNT Pharma conducted a double-blind, randomized, placebo-controlled phase III SMART trial of crisdesalazine for 48 companion dogs with CDS at 6 animal hospitals including Seoul National University Animal Hospital. All dogs were diagnosed as CDS according to canine cognitive dysfunction rating scale (CCDR score: 0-39 = normal, 40-49 = at risk, 50-80 = CDS). Baseline scores of CCDR before drug treatment were 61.7 2.8 for the placebo group and 62.2 2.3 for the crisdesalazine group. CCDR scores were 60.7 2.7 and 65.0 3.9 after 4-week and 8-week treatment with placebo. CCDR scores were reduced to 43.0 2.9 and 42.1 4.0 after 4-week and 8-week treatment with 5 mg/kg crisdesalazine, demonstrating significant beneficial effects of crisdesalazine vs placebo (p<0.0001). Similar beneficial effects were observed in companion dogs with CDS treated with 10 mg/kg crisdesalazine. Such beneficial effects lasted over at least 4 weeks after discontinuing 8-week treatment with crisdesalazine. Drug-related adverse events were not observed.

Administration of crisdesalazine significantly and noticeably improved cognitive function and behavioral activity without causing adverse effects in dogs with CDS that participated in the SMART trial. With rapidly increasing population of aged dogs, CCDS has been one of therapeutic areas with the highest unmet medical need. In light of proven efficacy and safety, crisdesalazine is expected to improve the quality of life of aged dogs with CDS and their owners, said Hwa-Young Youn, D.V.M. and Ph.D., Professor of Veterinary Medicine at Seoul National University, Principal Investigator of SMART trial.

We are excited to receive a new drug approval for the treatment of old dogs with CDS. The novel dual antioxidant and anti-inflammatory action of crisdesalazine, which was shown to reduce amyloid plaque, tauopathy, and neurodegeneration in various cell culture and animal models, has the potential to revolutionize how we care for CDS, said Byoung Joo Gwag, Ph.D., GNT Pharmas President and CEO, Adjunct Professor of Biological Sciences at Yonsei University. Crisdesalazine, the first multi-target drug proven and approved for CDS featuring brain pathology similar to AD, gives hope for better treatment of AD patients. We plan to initiate a pivotal clinical trial of crisdesalazine for patients with mild to moderate AD this year.

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GNT Pharma's GedaCure Approved for the Treatment of Dogs With Cognitive Dysfunction Syndrome - Business Wire