Gabather AB reports today that the clinical phase 1 study in healthy volunteers with single ascending doses (SAD study) of GT-002 has been successfully completed. No drug-related adverse events have been reported and the preliminary conclusion is that the drug is safe and well tolerated, and that the pharmacokinetic properties of GT-002 is very promising. The final study report containing all safety data and a final evaluation of the pharmacokinetic results will be available to the company in June 2019.
The completion of the phase 1 study is a major milestone in the Company's development of the lead clinical candidate, GT-002, towards further studies in patients. The results that have been generated in the study will form the basis for the planning and implementation of the subsequent clinical studies including Multiple Ascending Dose (MAD) studies in which GT-002 will be given repeatedly for a limited time to evaluate safety and pharmacokinetics. A so-called "Proof-of-concept" (PoC) study in patients is planned where valuable data will be collected regarding the efficacy of GT-002 on CNS disorders either as a separate study or in combination with the MAD study.
Details about the phase 1 SAD study can be found in the following link: www.clinicaltrials.gov/ct2/show/NCT03817346?term=gabather&rank=1
Gabather AB
Michael Robin Witt, CEO
E-mail: mrw@gabather.com
Phone nr: 0736872839
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 and Certified Advisor is Erik Penser Bank (+46 (0) 8-463 83 00) or certifiedadviser@penser.se.
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.
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 15.40 on the 25th of April 2019.