Bright Minds Biosciences has completed its Phase I first-in-human study of BMB-101 being developed for the treatment of refractory epilepsies, psychosis, addiction, and impulse control disorders.

The three-part study assessed the pharmacokinetic (PK), tolerability, safety, and food effect of the 5-HT2C agonist BMB-101 in healthy volunteers.

It was carried out by CMAX Clinical Research in Adelaide, Australia.

Healthy volunteers were randomised into four cohorts (six drug and two placebo) who received oral dose of BMB-101 two times a day for seven days after meals.

A top dose of 150mg/70kg twice a day was achieved and biomarkers for central target engagement were determined as prolactin release and qEEG.

A dosage of BMB-101 120mg/70kg with and without breakfast was administered to 12 subjects in a crossover study. Effect of food on these levels was relatively small, hence it was advised that the therapeutic can be administered without the need for fasting.

With further formulation in development, the company intends to treat subjects once in a day with single dose.

The lead compound BMB-101 demonstrated favourable safety and tolerability profile with transient, dose-dependent increases in prolactin.

It also demonstrated predictable plasma pharmacokinetics with relatively small inter-individual variability.

Bright Minds chief medical officer Mark Smith said: “We are highly encouraged by the Phase I study observations and results, which give us confidence in selecting doses of BMB-101 for testing in refractory epilepsies and other disorders where serotonin 2C agonists are indicated.

“Learnings from the study will inform our path forward as we seek to develop effective therapeutic options with convenient dosing regimens for patients.”

The company is also planning to initiate a Phase II study, based on the observations from the Phase I study.