Perception Neuroscience has reported positive data from its first Phase 1 clinical study of PCN-101 (R-ketamine) in healthy adult participants.
A stereoisomer of ketamine, R-ketamine is being developed for treating psychiatric illnesses such as treatment-resistant depression (TRD).
The single-centre, randomised, placebo-controlled, double-blind single ascending dose study analysed the safety, tolerability and pharmacokinetics of PCN-101. It also included a subsequent relative safety comparison of PCN-101 and S-ketamine.
In the study, healthy participants received a single 40-minute intravenous infusion of PCN-101 or a placebo.
The initial stage of the two-stage study analysed the safety, tolerability and pharmacokinetics of single ascending doses of PCN-101 in 58 healthy adult participants versus placebo.
Results showed that PCN-101 was safe and well-tolerated at all doses up to the highest dose tested of 150mg.
PCN-101’s pharmacokinetics in plasma was about dose-proportional with no serious adverse events reported in the study.
The study’s second stage analysed the relative safety and tolerability of PCN-101 to that of S-ketamine. Data showed that PCN-101 needed higher doses to stimulate similar perceptual changes than S-ketamine.
Perception Neuroscience CEO Terence Kelly said: “We are excited by the Phase I results that support the hypothesis that PCN-101 can be developed as a rapidly acting antidepressant with the potential for at-home use.
“The upcoming Phase II proof-of-concept trial in patients with Treatment Resistant Depression is the next important step in demonstrating the full potential of PCN-101.”
The company has obtained additional funding in a financing round that was led by atai Life Sciences to initiate the Phase IIa proof-of-concept study of PCN-101. This study is anticipated to begin in the second quarter of this year.
atai Life Sciences CEO and co-founder Florian Brand said: “The success of Perception’s Phase I clinical study leads us to believe that PCN-101 has the potential to offer a highly differentiated profile from current treatment options.”