Clinical stage biopharma company Bionomics (ASX: BNO) is celebrating this morning after being granted “fast track designation” for its BNC210 development program for the treatment of post-traumatic stress disorder (PTSD) by the US Food and Drug Administration (FDA).
Fast track designation is a purposed FDA program that expedites drug development while reviewing new drugs to address an unmet medical need in the treatment of a serious or life-threatening condition.
The fast track designation also includes other trauma and stressor-related disorders which Bionomics may, or may not, choose to take up in future.
The impact of PTSD
PTSD is associated with changes in brain function and has been recognised in the US as a “psycho-biological mental disorder” which tends to affect military veterans, victims of terrorist attacks, natural disasters, serious accidents, assault, abuse, or extensive emotional impacts following major trauma.
Scientific research has shown that from the 70% of people that go through tragic and traumatic events in their lives, more than 20% are likely to develop PTSD.
The annual financial cost is estimated to exceed $42 billion in the US alone, often exacerbated by misdiagnosis, mistreatment as well as psychiatric treatment, indirect workplace effects and the negative impacts of existing prescription drugs.
Bionomics is, therefore, developing a drug that seeks to remedy an unmet medical need, or in other words, to affect a condition whose treatment or diagnosis is not adequately addressed by existing treatments. This can mean either that the drug treats a condition for which no other treatment exists, or that it confers some benefit that existing treatments do not.
For the time being, the only available treatment for PTSD sufferers is variable doses of SSRI drugs such as sertraline and paroxetine – both of which have been reported to deliver severe side effects while reducing patient quality of life.
Developing a treatment for PTSD
Currently, Bionomics is developing a novel solid dose formulation of BNC210 which has been shown to achieve the blood levels predicted as necessary to meet the clinical trial primary endpoint for effectiveness for treating PTSD patients.
With this initial effectiveness confirmed, the biopharma company is now busy preparing to optimise its intended solid dose formulation in anticipation of a phase 2b trial in PTSD patients, to be conducted across multiple sites in Australia and the US.
“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,” said Dr Errol De Souza, executive chairman of Bionomics.
Bionomics has been expressly focused on progressing BNC210 for the past year and said that the drug’s development is “on track” after extensive pharmacometric analysis and two pharmacokinetic studies were completed successfully.
With the FDA’s fast track designation now obtained, Bionomics is set to access exclusive developmental benefits including more frequent meetings with FDA officials, eligibility for accelerated approval and priority reviews.
Possibly most important for Bionomics will be eligibility for what’s known as “rolling review” access – a measure that enables drug companies to submit completed sections of their new drug applications (NDA) for FDA review, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.
Such access can greatly expedite drug development given the more focused and prioritised approach taken by the US regulator to new drugs.
Financial metrics update
In addition to the regulatory boost, Bionomics is also buoyant due to a relatively strong quarterly cashflow report published last week.
The company said that it had received a sum of over $1.3 million as a research and development tax incentive refund for the 2017/2018 financial year.
Furthermore, the company reported a cash balance of $9.36 million with net operating cash outflow of $2.56 million for the past quarter. Cash receipts from customers totalled $1.03 million while research and development costs decreased by almost 50% compared to Q2 2019.
In the report, the company said: “We continue to assess the strategic options for partnering and portfolio prioritisation whilst protecting our major assets and conserving cash. The feasibility of funding a second clinical trial of BNC210 is currently being assessed.”
The news was well-received pushing Bionomics’ shares up by over 27% up to $0.12 in morning trade.