GNT Pharma's Dementia Drug 'Chrisdesalazine' Receives IND Approval for Phase 2 Clinical Trial

GNT Pharma announced on the 3rd that it has received approval from the Ministry of Food and Drug Safety for the clinical trial application (IND) of the Phase 2 clinical trial of Crisdesalazine, a treatment under development for degenerative brain neurodegenerative diseases, targeting patients with Alzheimer's dementia.

GNT Pharma is developing 'Crisdesalazine' as a treatment for Alzheimer's dementia.
Photo by GNT Pharma

This clinical trial is a multinational study involving 132 patients with mid-stage Alzheimer's disease who have cognitive impairment and tested positive on brain amyloid positron emission tomography (PET) imaging. The subjects will be administered either a placebo or Crisdesalazine orally once daily for 26 weeks in a double-blind manner to evaluate efficacy and safety. In South Korea, Professor Choi Seong-hye, a renowned dementia specialist at Inha University Hospital's Department of Neurology, will serve as the principal investigator of the clinical trial.

Crisdesalazine previously demonstrated safety and pharmacokinetics in a Phase 1 clinical trial involving 72 adults, including elderly subjects. Notably, it was confirmed that companion dogs suffering from cognitive dysfunction syndrome, often called "dog dementia" due to its similarity to Alzheimer's disease, showed significant improvement in cognitive function and social activity after taking Jedacure, an animal drug containing Crisdesalazine, for more than four weeks. Jedacure received the first synthetic new animal drug approval in South Korea in February 2021 and is currently sold in over 1,870 animal hospitals nationwide.

Gwak Byung-joo, CEO of GNT Pharma, stated, “Currently used Alzheimer's disease treatments not only cause serious side effects in some patients but also show only mild effects in early-stage patients. We expect that the efficacy of Crisdesalazine, confirmed in companion dogs who lost their memory, will be reproduced in this Phase 2 clinical trial, potentially restoring memory in patients with mid-stage Alzheimer's disease.”