Bionomics Limited announced the initiation of a 7-day dosing pharmacokinetic (PK) study in healthy volunteers using the newly developed solid dose tablet formulation of Bionomics' 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, that read out in October 2018. Pharmacometric 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 for BNC210 to treat PTSD symptoms provided that adequate blood levels can be achieved. Pharmacokinetic data from the 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 pharmacometric modelling to give clinically meaningful and statistically significant results in PTSD patients. The 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.