Research & Development
Bionomics receives Fast Track Designation grant from US FDA for BNC210 development program for PTSD treatment
4 November 2019 -

Clinical stage biopharmaceutical company Bionomics Limited (ASX:BNO, OTCQX:BNOEF) disclosed on Monday that its BNC210 development program, for the treatment of Post-Traumatic Stress Disorder (PTSD) and other trauma-related and stressor-related disorders, has been granted Fast Track designation by the US Food and Drug Administration (FDA).

Bionomics stated that it is currently developing a novel solid dose formulation of BNC210 which has recently been shown to achieve the blood levels predicted as necessary to meet the clinical trial primary endpoint for effectiveness for treating PTSD patients. It added that preparations are underway for optimisation of the solid dose formulation in anticipation of initiation of a Phase 2b trial in PTSD patients.

Dr Errol De Souza, Executive Chairman of Bionomics, stated: "FDA's decision to grant Fast Track designation is an important recognition of the high unmet medical need in PTSD and potential benefits of BNC210 with a novel mechanism of action in the treatment of this disorder."

"We are pleased with the progress that we have made over the last year in getting BNC210 back on track by carrying out extensive pharmacometric analysis and two pharmacokinetic studies demonstrating that the target blood levels predictive of efficacy in the treatment of PTSD can be achieved with our new solid dose formulation. We look forward to taking advantage of the Fast Track designation and working closely with FDA in the design and initiation of the next Phase 2b study in PTSD patients."

Bionomics uses its proprietary platform technologies to discover and develop a deep pipeline of best in class, novel drug candidates. The company's lead drug candidate BNC210 is a novel, proprietary negative allosteric modulator of the alpha-7 (α7) nicotinic acetylcholine receptor. Bionomics also has a strategic partnership with Merck & Co. Inc (known as MSD outside the US and Canada) and a pipeline of pre-clinical ion channel programs targeting pain, depression, cognition and epilepsy.



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