- Bionomics has been granted FDA approval for fast track classification of its PTSD treating drug
- The drug has been shown to achieve the predicted blood levels needed to meet the trial endpoint
- Bionomics is now in the process of looking to start a phase 2b trial
- The company’s share price is currently 33 per cent higher with shares trading for 12.5 cents apiece
Bionomics has been granted U.S. FDA approval for the fast track designation of BNC210 in treating PTSD.
Bionomics is currently developing a novel solid dose formulation of BNC210 which has been shown to achieve a blood level predicted to meet the endpoint for effectively treating PTSD.
PTSD (post-traumatic stress disorder) is a disorder characterised by the failure to recover after experiencing or witnessing a terrifying event.
Symptoms may include nightmares, flashbacks, anxiety, depression, or the avoidance of situations that bring back the trauma.
Preparations are now underway for optimisation of a solid dose formulation in anticipation for beginning a phase 2b trial in patients.
BNC210 is an anxiolytic drug (medication that discourages anxiety) that acts via negative allosteric modulation (group of substances) of the a7-nicotine acetylcholine receptor (receptor compromised of long-term memory).
“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,” Executive Chairman Dr Errol De Souza said.
“We are pleased with the progress that we have made over the last year in getting BNC210 back on track by carrying out extensive pharmacometrics analysis and two pharmacokinetic studies demonstrating that the target blood levels can be achieved,” he added.
The fast track designation in an FDA program that is intended to ease and accelerate development and review of new drugs to meet the unmet medical need in the treatment of a serious or life-threatening condition.
Once the drug has received approval, there are more frequent meetings with the FDA to discuss the development plan of the drug and collections are guaranteed of appropriate data needed to support drug approval.
The company will also have the eligibility for accelerated approval and priority review if relevant criteria are met.
“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,” Dr Errol concluded.
In light of this news Bionomics’ share price is on the rise, currently up 33 per cent with shares trading for 12.5 cents apiece at 11:30 am AEDT.