Gabather AB submits a Clinical Trial Application to further advance the development of GT-002
Gabather's clinical development with its lead compound GT-002 aims at a Proof-of-Concept (PoC) study addressing cognitive deficits in depression as the first indication. A single-dose target engagement study in healthy volunteers using electroencephalography (EEG) and the safety data acquired from the Multiple ascending dose study (MAD) will guide the design of this efficacy study in patients in an adaptive design.
As the next step in this clinical development programme, Gabather AB has today submitted an application to the regulatory authorities in Portugal for the start of a double-blind, placebo controlled Multiple Ascending Doses (MAD) clinical trial in up to 24 healthy volunteers. This study primarily investigates the safety and tolerability of multiple escalating doses of GT-002. The pharmacokinetic properties of GT-002 upon repeated administration will also be investigated. Dosing of the healthy volunteers in the MAD study are expected to start as scheduled in Q1 2020. In parallel during the spring the target engagement study is planned to commence, followed by the start of PoC study in the latter part of 2020.
"We are particularly enthusiastic to include EEG in the study design as we expect this to enable early partnering given positive data readout", says Michael-Robin Witt, CEO.
About Gabather AB (publ)
Gabather was founded in 2014, based on 10 years research at Lund University and Research Institute of Biological Psychiatry in Roskilde, to develop new drug candidates for the treatment of CNS diseases. Gabather was founded by Forskarpatent I Syd AB and inventors Olov Sterner and Mogens Nielsen, with the purpose of commercializing Sterner's and Nielsen's inventions. Sterner has worked with medicinal chemistry for 40 years, and Nielsen has worked in neuroscience for 45 years.
Gabather is listed on Nasdaq First North Growth Market and Certified Advisor is Erik Penser Bank and are reachable via +46 (0) 8-463 83 00 or [email protected].
Forward-looking statement
This press release contains forward-looking statements that constitute subjective estimates and forecasts about the future. Assessments about the future are only valid on the date they are made and are, by their nature, similar to research and development work in the biotech field, associated with risk and uncertainty. In light of this, actual outcomes may differ substantially from what is described in this press release. Gabather is listed on First North Growth Market and Eric Penser Bank is Certified Advisor.
This information is information that Gabather AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, by the above contact, for publication at 20.30 on the 22nd of January 2020.
Om Gabather
Gabathers affärsidé är att utveckla nya läkemedel för att behandla sjukdomar inom det centrala nervsystemet med nya verkansvägar, större träffsäkerhet och mindre biverkningar.
