The primary objective of the phase II clinical trial is to evaluate the safety and tolerability of multiple doses of PRX-00023 in patients with moderate to severe generalized anxiety disorder (GAD).
PRX-00023 is a proprietary, potent serotonin 1A (5HT1A) receptor agonist which has shown clear induction of surrogate biomarkers and was well tolerated in three phase I clinical studies in normal volunteers. Additional studies in major depression are planned for the future.
“We are very excited about the results from our three phase I trials with PRX-00023,” stated Dr Michael Kauffman, president and CEO of Predix. “Our goal in this program is to develop PRX-00023 as an anxiolytic and antidepressant with no sexual side effects and with rapid onset of action.”
Other compounds that target 5HT1A have been approved for GAD and have shown efficacy in major depression; however, PRX-00023 is designed to selectively interact with the 5HT1A receptor in the brain.