Data supports further exploration of candidate as a rapid-acting anti-depressant for home use
Atai Life Sciences, a company focusing on transforming the treatment of mental health disorders, has announced the results from Perception Neuroscience’s intravenous-to-subcutaneous bridging study of its PCN-101 (R-ketamine) candidate.
PCN-101 is a single isomer of ketamine and forms part of a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant activity. Depression model studies in rodents indicate that R-ketamine could possess more durable effects than S-ketamine.
The phase 1 open-label trial analysed the tolerability, safety and pharmacokinetic profile of 60mg, 90mg and 120mg of PCN-101 when delivered subcutaneously (SQ) in contrast to 60mg of PCN-101 delivered intravenously (IV).
The research has enrolled 16 healthy volunteers, who have all been entered into one of four sequences of drug administration.
The trial was designed to provide data on dosing regimens of the new subcutaneous formulation, which may optimise the therapeutic index of the candidate across future studies, consequently supporting further exploration of R-ketamine as a rapid-acting anti-depressant for home use.
Pharmacokinetic (PK) analysis demonstrates that 120mg of PCN-101 delivered SQ resulted in an approximate doubling of drug exposure while sustaining around the same maximum concentration as the 60mg IV dose.
In addition, PCN-101 was well-tolerated, with no serious adverse events reported. Meanwhile, at the 60mg IV dose, rates of sedation and dissociation were consistent with prior studies of the candidate.
The safety and tolerability profile of PCN-101 compares favourably to that of existing therapy, Spravato, while rates of sedation and dissociation were similar to those seen in the placebo arms of both the prior phase 2 study of PCN-101 and the Spravato clinical trials in depression.
