• Crisdesalazine vertoonde een significante verbetering van de cognitiefunctie in de primaire uitkomstmaat
• Crisdesalazine vertoonde een significante verbetering van dementie in de secundaire uitkomstmaten

YONGIN, Zuid-Korea – (BUSINESS WIRE) – GNT Pharma heeft met succes een klinische fase III-studie afgerond voor crisdesalazine, een nieuw medicijn voor de behandeling van cognitieve dysfunctie syndroom bij honden met de ziekte van Alzheimer.

In de klinische studie uitgevoerd met 48 gezelschapsdieren met ernstige cognitieve disfunctie in 7 veterinaire ziekenhuizen, waaronder Seoul National University Animal Hospital, toonde de met crisdesalazine behandelde groep een uitstekende en significante effectiviteit in vergelijking met de placebogroep in de beoordelingsschaal voor cognitieve stoornissen bij de hond, de primaire uitkomstmaat, evenals in de beoordelingsschaal voor dementie bij de hond, de secundaire uitkomstmaat. De werkzaamheid werd zowel bij de behandeling van 4 weken als van 8 weken vastgesteld bij gezelschapsdieren die 5 mg / kg of 10 mg / kg crisdesalazine ontvingen. Er zijn geen bijwerkingen gevonden in verband met de toediening van crisdesalazine.

GNT Pharma’s Anti-dementia Drug ‘crisdesalazine’ Demonstrates Efficacy in Phase III Clinical Study with Companion Dogs with Dementia

• Crisdesalazine demonstrated significant improvement in cognition function in the primary outcome measure
• Crisdesalazine demonstrated significant improvement in dementia in the secondary outcome measures

YONGIN, South Korea–(BUSINESS WIRE)– 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.”

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Contacts

GNT Pharma

Dr. Jin Hwan Lee

+82-70-4261-0797

jhlee@gntpharma.com