Approval to a Phase 1 Clinical Study

Approval to Initiate a Phase 1, First–In-Man, Clinical Study for Q134R

Soneas Research Ltd. in collaboration with Avidin received approval to initiate a Phase 1, First–In-Man, clinical study for Q134R. Q134R is a potent, selective, orally available small molecule that is brain penetrant and showed good toxicity and metabolic stability profile in preclinical studies. Q134R exhibited neuroprotective and cognitive enhancing activities in different preclinical models and hopefully will show clinically potent effects against neurodegenerative diseases, including Alzheimer`s disease in future clinical trials.

Recruitment of healthy male individuals will start in early October, 2016.

“We are delighted to receive this approval for Q134R and to be able to initiate clinical development of this exciting molecule,” said Sándor Bátori, PhD., Project Leader for the Q134R program.  “We believe the speed at which the Hungarian authorities approved the clinical trial application attests to the quality of our preclinical data and related material.”

Project Title

A PHASE 1, SINGLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED CLINICAL STUDY TO EXAMINE THE TOLERABILITY, SAFETY AND PHARMACOKINETICS OF SINGLE ASCENDING DOSES OF Q134R-K IN HEALTHY MALE VOLUNTEERS