Australian drug development company Bionomics Limited (ASX:BNO, OTCQX:BNOEF) will launch a key Phase 2 trial of its novel anxiety drug BNC210 as a treatment for post-traumatic stress disorder (PTSD), following a US$12 million private placement to US institutional investors.
The new trial is expected to begin in the first half of 2016, with patients to be recruited at several trial sites in Australia and New Zealand. All patients enrolled will have experienced severe trauma, including war, natural disasters or have been involved in serious accidents.
The program will be funded with a US$12 million Private Placement to four US institutional investors.
Under the placement 40,207,472 shares will be issued at A$0.408 per share with attaching 40,207,472 warrants to purchase shares at A$0.5938 per share (the same price as the MSD investment), of which 16,082,988 warrants will be subject to shareholder approval at a shareholder meeting to be held early in 2016. Roth Capital Partners acted as the sole US Placement Agent in the transaction.
The Board recommends that shareholders vote to approve the issue of the warrants. The Board further advises that individual Board members will vote their shareholdings in favour of the issue of the warrants.
Bionomics CEO and Managing Director Dr Deborah Rathjen said all existing data indicated that BNC210, which is currently in trial to treat Generalised Anxiety Disorder, could be an effective therapy for PTSD patients.
"After reviewing the extensive datasets from pre-clinical studies and Phase I clinical trials of BNC210, we believe that the safety and efficacy profile of BNC210 suggests that it will be an effective treatment for PTSD sufferers," she said. "This trial will be critical to building out our clinical package to drive partnering deals."
The risk of developing PTSD after a traumatic event is 8.1% for men and 20.4% for women. Bionomics' study will recruit male and female subjects and will aim to demonstrate improvement in PTSD symptoms following 12 weeks of daily dosing with BNC210. Further study details will be provided on trial initiation.
It is estimated that approximately 8 million Americans, or 3.5% of the US population, suffer PTSD at any given time. Similarly, an estimated 1 million Australians experience PTSD in any year, and 12% of Australians will experience PTSD during their lifetime.
The anxiety and depression treatments markets are projected to reach US$18.2 billion by 2020 highlighting the significant market opportunity for BNC210.
BNC210 is a novel, orally-administered, first-in-class, modulator of the alpha-7 nicotinic acetylcholine receptor. BNC210 is currently undergoing a Phase II trial in Generalised Anxiety Disorder patients which is expected to report results in Q3 CY2016.
The company has previously reported clinical and preclinical data indicating that BNC210 is safe and well-tolerated and has strong potential as a new and effective treatment for other central nervous system indications.