The biopharmaceutical company, Bionomics Limited (ASX: BNO) made an announcement on 18 February 2019 regarding the Phase 2 Post Traumatic Stress Disorder Trial (PTSD). The company has announced that the Phase 2 PTSD trail is showing the potential for significant patient benefit when there is adequate drug exposure. Following the release of this news, the share price of Bionomics Limited increased by 75% as on 18 February 2019 (AEST 3:14 PM).
An additional data analysis conducted in Sweden by Pharmetheus AB showed a statistically significant response when drug exposure versus response was measured in the Phase 2 PTSD Trial (referred to as the RESTORE trial). The exposure-response analysis demonstrated a reduction in total PTSD symptoms as measured by total CAPS-5, the endpoint mandated by the US Food & Drug Administration (FDA) for PTSD trials.
As per the Executive Chairman of Bionomics, the company had a solid scientific rationale for evaluating BNC210 in PTSD, based on its mechanism of action. He further told that, 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.
According to him, 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 the company’s ongoing partnering activities.
The company is now going to seek FDA guidance on the next steps for BNC210 for PTSD including the design of a further trial and whether BNC210 is eligible for Fast Track designation. The company will continue to evaluate partnership opportunities in parallel.
The company has now found out an improved solid dose formulation of BNC210 which is having a potential to overcome the “food effect” and the consequent variable blood levels that were evident in the PTSD trial where the patients were administered BNC210 in a liquid formulation. It is expected that the solid dose formulation will be used in any future PTSD trials.
With regards to the ongoing Phase 2 exploratory clinical trial of BNC210 in elderly patients with Agitation, the company is planning to conduct similar exposure-response analyses. Full recruitment of Phase 2 exploratory clinical trial of BNC210 is anticipated toward the end of quarter one 2019, with data expected to be available in late Q2, 2019. Recently on 15 February 2019, the company posted its half-yearly results for the period ended 31 December 2018 in which it reported a 19.3% increase in Net Loss in 1H FY2019.
BNO’s stock is currently trading at a price of $0.210 with a market capitalization of ~$65.36 Million. The counter opened the day at $0.165 and reached the day’s high of $0.210 and touched the day’s low of $0.155 with a daily volume of ~ 12,537,708. The stock has provided a YTD return of 11.63% & also posted returns of -73.91%, -7.69% over the past six months and three months period respectively. It had a 52-week high price of $0.640 and touched 52 weeks low of $0.099, with an average volume of ~ 629,006.
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