Anti-anxiety drug into phase 2 trial

drug testing
Published: 
19 March 2016

Australian drug development company Bionomics Limited is set to launch a Phase 2 trial of its anti-anxiety drug BNC210 as a treatment for post-traumatic stress disorder (PTSD), following a US$12 million cash injection from United States institutional investors, scientific bloggers are reporting.

The new trial is expected to begin in the first half of this year, 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 United States institutional investors.

Bionomics CEO Dr Deborah Rathjen is reported as saying all existing data indicated that BNC210, which is currently in trial to treat Generalised Anxiety Disorder, could be an effective therapy for PTSD patients.

The journey of BNC210 is an interesting one. In 2013, Adelaide-based Bionomics signed a deal worth up to $345 million with United States-based Ironwood Pharmaceuticals to help develop its anti-anxiety drug BNC210.

At that time Deborah claimed the deal was one of the largest ever for an Australian company with a Phase 1 drug candidate.  BNC210 is the first drug of its kind for the treatment of anxiety, which affects over two million Australians.

The Phase 1 clinical trials identified it's potential for fast relief from anxiety without nasty side effects. Conventional treatments can be addictive and cause drowsiness and impaired memory. They can also react adversely with other medications. Successful trials were crucial to closing the deal with Ironwood Pharmaceuticals.

In one of the clinical trials, BNC210 was tested on people who were subjected to a chemically induced panic attack. Treatment with BNC210 clearly reduced anxiety symptoms. The people returned to a normal emotional state in ten minutes compared with around an hour for those on a placebo.

In another clinical trial, BNC210 was compared with Lorazepam, a drug similar to Valium. People had EEG leads attached to their scalp to measure brain activity. Those on BNC210 performed better across a range of indicators including attention, memory, and co-ordination.

Deborah believes intellectual property is vital to Bionomics' success. 'A deal of this kind simply wouldn't happen without patent protection. I can draw a direct link between our patents and the millions of dollars needed to get life changing therapies to market.'

Bionomics is positioned to target large markets inadequately served by current treatments. The company combines innovation with a global partnering strategy to secure development expertise and investment.

BNC210 trials mapped brain activity in test subjects

'We're in the enviable position of having an innovative pipeline comprising first-in-class and best-in-class drug candidates with block buster potential', says Deborah

These include other programs like: 

 

  • BNC105, a potent treatment that shuts down the blood supply to solid tumours and starves them of nutrients
  • KV1.3, targeting the US$12 billion market for Multiple Sclerosis treatments
  • Alpha 7 tackles memory impairment, including Alzheimers.

Deborah notes that major pharmaceutical companies are facing a significant "patent cliff". Many blockbuster drugs are either about to come off patent or already subject to generic competition.

'As a novel drug, BNC210 is at the forefront of development for anxiety and depression. BNC210 also has a very strong patent position and, with the first patent application filed in 2006, a long period of patent protection ahead of it.'

Bionomics is counting on the power of its patents to continue delivering strong business growth.