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.