Positive results for Bionomics' solid dose formulation of BNC210

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Bionomics (ASX:BNO) has announced positive results from a pharmacokinetic study in healthy volunteers using the newly developed solid dose formulation of its lead drug candidate, BNC210.

The company said the study demonstrates that the solid dose of BNC210 achieves the blood levels predicted as necessary to meet the primary endpoints for effectiveness for treating Post-Traumatic Stress Disorder (PTSD) patients in future clinical trials.

It said the study is the culmination of efforts designed to overcome the failure of the liquid suspension formulation to provide sufficient blood exposure for efficacy in the Phase 2 PTSD trial, RESTORE.

The liquid suspension formulation of BNC210 used in the RESTORE trial was required to be taken with food, gave variable absorption and consequently lower exposure than expected.

A pharmacometric analysis of the PTSD trial data showed an exposure-response relationship between BNC210 blood levels and CAPS-5 scores, the primary endpoint measure in PTSD trials, and the potential of BNC210 to treat PTSD symptoms provided that adequate blood levels could be achieved (Area Under the Curve or AUC ~25 mg.h/L).

Bionomics said these new pharmacokinetic data from the single ascending doses of BNC210, along with data reported earlier this year demonstrating that the solid dose formulation can overcome the 'food effect', show that the solid dose formulation of BNC210 can reach blood levels required to achieve exposures predicted to give clinically meaningful and statistically significant changes from placebo on Total CAPS-5 scores.

The company also said it recently attended a supportive Type C meeting with the FDA to discuss the further development of BNC210 using the solid dose formulation for the treatment of PTSD. It subsequently submitted a request for Fast Track designation for BNC210.