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 antidepressant 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 welltolerated, 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.

Evgen Pharma – a company developing sulforaphane-based therapies – has issued the final data from its phase 1b healthy volunteer trial of its SFX-01 candidate. The study is specifically analysing the company’s new enteric coated tablet formation of the drug.

The data concerned has been released in an extensive clinical study report (CSR) in compliance with good clinical practice (GCP).

The study aimed to establish how sulforaphane released from the tablet formulation was absorbed from the intestine and its wider impact on the physiology of trial participants.

This new data contains details of the full pre-specified pharmacodynamic and pharmacokinetic dataset from placebo-controlled, randomised, dose-escalating research.

Notably, sulforaphane (SFN) was released by the new enteric coated tablet beyond the acid environment of the stomach. Furthermore, total blood levels of SFN and SFN-metabolites were confirmed in the micromolar range, where efficacy is witnessed in vitro.

Additional pharmacodynamic exploratory investigations, incorporating mRNA sequencing, demonstrated alterations in gene expression after dosing.

Dr Glen Clack, CMO at Evgen, explained: “The pharmacodynamic data generate a number of hypotheses relevant in both oncology and other conditions that we continue to explore. These insights will be used in our grant-funded collaborations with the Erasmus Medical Centre in Rotterdam in glioblastoma and with our partner, Stalicla, in ASD.”