Bionomics Limited (ASX:BNO), the clinical stage biopharmaceutical company, has fallen in the red zone with a significant fall of about 56% on October 02, 2018 (1:00 PM AEST), after announcing a discouraging clinical trial result for its BNC210 drug. The group’s top-line data from its Phase 2 clinical trial of BNC210, a negative allosteric modulator of the ?7 nicotinic acetylcholine receptor, in patients with Post Traumatic Stress Disorder (PTSD) has revealed that the trial failed to meet the primary endpoint of decline in PTSD symptoms, measured by CAPS-5 at 12 weeks.
Primarily, the group had indicated that about 193 patients with PTSD across US and Australia (25 sites) were assessed for symptoms under the trial. While there was no overall treatment effect assessed by CAPS-5, the group’s drug BNC210 exhibited first-rate tolerability and safety supporting the safety profile when administered for the first time over a prolonged 3-months’ treatment period. Thus, while the result was not as expected, there were some improvements on few components of the scale and these related to the mood and anxiety symptoms of the condition. The group has categorically focussed on the unmet medical need for safe and effective treatments for PTSD; however, as per the Bionomics consultant Dr. Murray Stein, Professor of Psychiatry, Family Medicine and Public Health at the University of California San Diego, the beneficial effects on improving PTSD symptoms and development of the drug as a novel treatment for the condition have not been demonstrated. BNO now aims to have future work with BNC210 and other novel compounds on a subset of symptoms, or patients, which can still prove beneficial. At the moment, BNO will aim to complete the ongoing Phase 2 trial of BNC210 in hospitalised, elderly patients who suffer from agitation; and this is scheduled for a readout in Quarter 1 of 2019 while it will suspend other work on BNC210 till the above is done.
On the other hand, the group is undertaking drug discovery programs that may deliver up to two new therapeutic candidates in FY19; and is also evaluating a cognition therapy candidate in an ongoing Phase 1 program, progressed to clinical development and related to a US $ 10 million milestone payment under BNO’s strategic arrangement with Merck & Co. (MSD outside the United States and Canada). The potential value of over US $ 505 million in terms of the upfront payments, R&D payments and milestone payments, with additional annual royalties on net sales of licensed drugs, has been indicated for the above; and the group is still confident on its robust pipeline given the relationship with MSD.
BNO has otherwise taken charge on costs etc. with the shutting down of US operations and reducing overall headcount in FY18; and still aims to set its strategic options for partnering and portfolio prioritisation to have better shareholder value. An insight on this will be provided at the Annual General Meeting scheduled for November 14, 2018.
As of now, the result has led to a wave of uneasiness among investors as the primary endpoint of the trial was not met. The stock was up about 8.7% in last one year and witnessed some bit of volatility lately.
With the development at hand, the stock would be under the purview as many investors have pressed the sell button as at October 02, 2018.
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