Research & Development
US FDA Grants Fast Track Designation to BNC210 Development Programme for the Treatment of PTSD
5 November 2019 - - The US Food and Drug Administration has granted Fast Track designation to the BNC210 development programme for the treatment of Post-Traumatic Stress Disorder and other trauma-related and stressor-related disorders, Australian clinical stage biopharmaceutical company Bionomics Ltd. (ASX: BNO) (OTCQX: BNOEF) said.
Bionomics 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; preparations are underway for optimization of the solid dose formulation in anticipation of initiation of a Phase 2b trial in PTSD patients.
Fast Track designation is a FDA program intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.
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. Bionomics' lead drug candidate BNC210 is a novel, proprietary negative allosteric modulator of the alpha-7 nicotinic acetylcholine receptor.
Beyond BNC210, Bionomics has a strategic partnership with US-based Merck and Co., Inc (NYSE: MRK) and a pipeline of pre-clinical ion channel programmes targeting pain, depression, cognition and epilepsy.