Bionomics Ltd (ASX:BNO) (OTCMKTS:BNOEF) has initiated a 7-day dosing pharmacokinetic (PK) study in healthy volunteers using the newly developed solid dose tablet formulation of its lead drug candidate, BNC210.
BNC210 has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of Post-Traumatic Stress Disorder (PTSD) and other trauma-related and stress-related disorders.
The new solid dose formulation of BNC210 has been developed to overcome the failure of the liquid suspension formulation (which has a requirement to be taken with food) to provide sufficient blood exposure for efficacy in the first BNC210 Phase 2 PTSD trial, RESTORE.
Pharmacometrics analysis of data from the RESTORE trial modelled an exposure-response relationship (between BNC210 blood levels and the primary endpoint measure in PTSD clinical trials,
CAPS-5 severity scores) and the potential to treat PTSD symptoms provided that adequate blood levels can be achieved.
“Pleased with progress”
Bionomics executive chairman Errol De Souza said: “We are pleased with the progress made in optimising the BNC210 tablet formulation to overcome the limitations of the previous liquid suspension formulation.
“We continue on our previously communicated timelines to confirm the pharmacokinetic profile of the optimised BNC210 tablet to demonstrate that blood exposures predicted from the pharmacometrics modelling are not only achieved but are maintained for a period of at least seven days.
“In parallel, we are preparing for the start of the Phase 2 PTSD study with the new tablet formulation projected for mid-2021.”
Study to determine dosing regimen
Pharmacokinetic data from earlier single-dose PK studies demonstrated that the tablet formulation does not have a requirement to be given with food and can reach blood levels required to achieve exposures predicted by pharmacometrics modelling.
Results from this 7-day, twice-daily dosing PK clinical trial in healthy subjects with the tablet formulation of BNC210 will be used to determine the dosing regimen of BNC210 that will be given to PTSD patients in a second Phase 2 clinical trial.
Tablets for the PK trial have been successfully manufactured, the study site has been formally initiated, and screening and selection of healthy volunteers for participation has commenced. Results from the study are expected later this quarter.
Bionomics is a global, clinical-stage biopharmaceutical company leveraging its proprietary platform technologies to discover and develop a deep pipeline of best in class, novel drug candidates.