- Bionomics’ share price jumped more than 44 per cent this morning after it received positive results from a clinical trial with lead drug candidate BNC210
- The trial demonstrated that a solid dose of BNC210 achieves the blood levels that are necessary in treating patients with PTSD
- Five healthy adult males took part in the trial with each receiving between 300 to 1200 milligrams of BNC210
- BNC210 is an orally-administered acetylcholine receptor that helps treat anxiety, PTSD, agitation and panic
Bionomics’ share price jumped almost 45 per cent this morning after it received positive results from a clinical trial using its lead drug candidate BNC210.
The study demonstrated that the solid dose of BNC210 achieves the blood levels predicted as necessary to meet the endpoints for the effectiveness in treating patients with post traumatic stress disorder (PTSD).
It was also well tolerated at the exposure levels reached in the healthy volunteers who took part in the study.
Five healthy adult male volunteers took part in the study and were administered between 300 and 1200 milligrams of BNC210.
Two weeks ago Bionomics submitted an application to fast track the drug for PTSD and if successful it will speed up the trial process and cut down the time needed to bring the medication into the market.
BNC210 is Bionomics’ novel, orally-administered, first-in-class nicotinic acetylcholine receptor (membrane protein that responds to cell signals) that helps treat anxiety, PTSD, agitation and panic.
However, outstanding trials could allow for the development of a more solid formulation.
No sedation is required, no withdrawal symptoms are experienced and it’s fast acting.
The study is the peak of efforts which were designed to overcome the failure of the liquid suspension formulation to provide sufficient blood exposure for efficacy in the Phase 2 PTSD trial.
The data from this trial, along with data reported earlier this year, demonstrates that the solid dose formulation can overcome the “food effect”.
This means that a solid application, that can give significant changes, should be taken shortly after a meal.
Bionomics recently attended a supportive Type C meeting (meeting regarding the review and development of a product) with the FDA to discuss the further development of BNC210.
It also submitted a request to fast track designation for BNC210.