Bionomics announced the U.S. 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.
BNC210 was previously studied in a phase 2 Post-Traumatic Stress Disorder (PTSD) trial which enrolled 193 adult patients across sites in the US and Australia. Results from the study showed that BNC210 did not significantly improve the symptoms of PTSD when compared to placebo. However, an exposure-response relationship was modelled from the trial data and established the potential for BNC210 to have significant benefit in PTSD provided that adequate exposure levels are achieved in the 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.
BNC210 is a novel, proprietary negative allosteric modulator of the alpha-7 (α7) nicotinic acetylcholine receptor.