Gabather AB initiates discussions with specialist doctors and researchers at Karolinska Institutet for the design of a study in individuals at risk of developing frontotemporal dem

Gabather approaching a significant milestone in the clinical development of GT-002. The Company has completed 3 clinical trials so far, each showing that GT-002 is safe and well tolerated in man. The next step in the development of GT-002 is clinical studies in patients with diagnoses where effective treatments are lacking.

Discussions with specialist doctors and researchers at the Karolinska Institutet have been initiated for the design of a study in individuals with genetic predispositions to develop FTD. Currently, there are no available specific treatments for FTD, and there is still no evidence of an effective symptomatic treatment.

The goal is to create ground-breaking symptomatic treatment of FTD. The intended study is a pilot study with the aim of laying the foundation for a larger multi-centre study with GT-002. At the same time, Gabather is working towards orphan drug status "Orphan Drug Designation" (ODD) for GT-002, with a planned advisory meeting with the European Medicines Agency (EMA) during the first quarter of 2024. ODD enables a faster review and approval of the drug candidate, which also creates new opportunities for licensing deals.

"We look forward with excitement to the continued clinical development of GT-002 with good opportunities to interest a major pharmaceutical company in the further development of GT-002 as an orphan drug for the treatment of FTD. Discussions with potential licensees will intensify in 2024 with presentations of our exciting new data generated during the target-engagement study, as well as the outcome of the consultative meeting with the EMA", says Michael-Robin Witt, CEO, Gabather.