The FDA has granted fast-track designation to Bionomics' (ASX:BNO) BNC210 development program for the treatment of Post-Traumatic Stress Disorder (PTSD) and other trauma-related and stressor-related disorders.
Adelaide-based Bionomics is a global, clinical-stage biopharmaceutical company discovering and developing a pipeline of novel drug candidates targeting ion channels.
The company is currently developing a novel solid dose formulation of BNC210 that it says 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.
“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.”
A drug that receives FDA fast track designation is eligible for a range of potential benefits, including more frequent meetings and written communication with the regulator, as well as eligibility for accelerated approval and priority review.