At time of writing, shares of Bionomics Ltd [ASX:BNO] are up by 62.5%, to 19.5 cents per share.
Why did Bionomics Ltd share price push higher?
Bionomics announced additional analysis conducted by Pharmetheus AB, showing a statistically significant response in the Phase 2 PTSD Trial (referred to as the RESTORE trial). The exposure-response analysis tested patients’ blood levels to the company’s drug, regardless of the administered dose. The analysis showed a reduction in total PTSD symptoms, as measured by total CAPS-5. That’s the endpoint mandated by the US Food & Drug Administration (FDA) for PTSD trials.
What’s up next for Bionomics Ltd?
The share price increased on the news:
Bionomics has traded sideways since September, when it decreased by more than 50%. The company announced that its trial didn’t meet the primary end point at the time. Of course, that’s changed now and the share price went up on the news today. In my opinion, the share price could hold this level for the time being, until the company advances through to the next stage of its trials.
I believe Bionomics could become a billion-dollar company, if it can get through its trial process and sell its drug ― BNC210. BNC210 aims to treat the large population of patients suffering with post-traumatic stress disorder (PTSD) worldwide. I see a need for a safe and effective treatment in the market.
Dr Errol De Souza, Executive Chairman of Bionomics, told the market today:
‘Bionomics had a solid scientific rationale for evaluating BNC210 in PTSD, based on its mechanism of action, and this has been borne out by this further analysis. At the time of the topline data announcement of 2 October 2018, the results of the complex and time-consuming drug exposure analyses were not available and could not have readily been foreseen. The results of the further analysis are meaningful for future development of BNC210 and they support its continued development for PTSD, as well as other indications, and our ongoing partnering activities.’
Bionomics has discovered an improved solid dose formulation of BNC210. It has the potential to overcome the ‘food effect’ by using a liquid formulation; as such, patients might not need to take the drug with food. It’s anticipated the solid dose formulation will be used in any future PTSD trials.
The company intends to seek FDA guidance on the next steps for BNC210, including the design of a further trial and whether BNC210 is eligible for Fast Track designation. If this is approved by the FDA, the share price could surge higher in my opinion.
Resources Analyst, Markets & Money