Bionomics Announces Fast Track Designation Granted by U.S. FDA to BNC210 Development Program for the Treatment of PTSD
FDAs 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, said Dr. Errol De Souza, Executive Chairman of Bionomics.
Bionomics Limited (ASX:BNO, OTCQX:BNOEF), a global, clinical stage biopharmaceutical company discovering and developing a pipeline of novel drug candidates targeting ion channels, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the BNC210 development program for the treatment of Post-Traumatic Stress Disorder (PTSD) and other trauma-related and stressor-related disorders.
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.
“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,” said Dr. Errol De Souza, Executive Chairman of Bionomics. “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.”
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. A drug that receives Fast Track designation is eligible for some, or all, of the following:
- More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
- More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
- Eligibility for accelerated approval and priority review, if relevant criteria are met
- Rolling Review, enabling a drug company to submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire drug application to the FDA.
About Bionomics Limited
Bionomics (ASX: BNO) 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 (α7) nicotinic acetylcholine receptor. Beyond BNC210, Bionomics has a strategic partnership with Merck & Co., Inc (known as MSD outside the United States and Canada) and a pipeline of pre-clinical ion channel programs targeting pain, depression, cognition and epilepsy.
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