Yesterday, top-line data from Bionomics Limited (ASX:BNO, OTCQX:BNOEF) revealed details of the biopharmaceutical company’s Phase II clinical trial of BNC210 in regards to patients with post-traumatic stress disorder (PTSD). BNC210 is an innovative negative allosteric modulator of the alpha7 nicotinic acetylcholine receptor.
“This trial comprehensively assessed symptoms in 193 patients with PTSD across 25 sites in the US and Australia,” explained Professor Paul Rolan, Bionomics’ consultant Chief Medical Officer. “We found that BNC210 showed excellent tolerability and safety. This adds to the safety picture for BNC210, administered for the first time over a prolonged 3-month treatment period. Although there was no overall treatment effect assessed by CAPS-5, we saw improvements on select components of the scale that are attributable to the mood and anxiety symptoms of the condition.”
Bionomics (ASX: BNO) is a worldwide clinical stage biopharmaceutical company working to create original drug candidates for cancer and central nervous system (CNS) disorders such as Alzheimer’s disease, anxiety, and depression. “Bionomics has a portfolio of well differentiated drug candidates. Each target the treatment of serious conditions with significant unmet clinical need, and for which large market opportunities exist. We are able to not only sustain but accelerate our pipeline development by virtue of two distinguishing attributes: 1) high quality drug candidates and 2) our strategic partnering strategy which allows multiple and diverse programs to be optimally developed,” quotes their website. At the BioPharma Asia Industry Awards during the BioPharma Asia Convention in 2014, Bionomics was named as the Innovative Asian Biotech of the Year.
Bionomics consultant Dr. Murray Stein, Distinguished Professor of Psychiatry, Family Medicine and Public Health at the University of California San Diego offered that “there is great unmet medical need for safe and effective treatments for the large population of patients suffering with PTSD worldwide. While challenging to find which symptoms may respond to the novel pharmacological properties of BNC210, there was great anticipation that it would show clear beneficial effects on improving PTSD symptoms, supporting further development of the drug as a novel treatment for this condition. Results of this trial do not demonstrate those broad benefits, underscoring the complexity of PTSD and the heterogeneity of PTSD symptoms across patients. Future work with BNC210 – and other novel compounds – may be best focused on a subset of symptoms, or a subset of patients, considered most likely to benefit.”
Their pipeline divides into the aforementioned two areas of specialty, CNS and oncology. BNC210 is the company’s lead drug candidate, with primary indications in PTSD, agitation, GAD, and panic. Results divulging that the drug has been ineffective may prove to be detrimental to the company’s efforts. Since the announcement yesterday morning, the Bionomics share price has dropped 69%, a 52-week low.
“We are extremely disappointed that the primary endpoint in this trial was not met. As we move forward we will focus on the completion of the ongoing Phase 2 trial of BNC210 in hospitalised, elderly patients suffering from agitation which is anticipated to readout in Q1, 2019. We plan to stop all other work on BNC210 until that time,” disclosed Dr. Deborah Rathjen, CEO & Managing Director of Bionomics. “In FY18 Bionomics reduced costs by closing the US operations and reducing overall headcount. In order to maintain and enhance shareholder value, we are continuing to assess our strategic options for partnering and portfolio prioritisation whilst conserving cash. We will provide an update on our strategic direction at the Annual General Meeting to be held on 14 November.”
“Bionomics has ongoing drug discovery programs which are anticipated to deliver up to two new therapeutic candidates this financial year. We also have a strategic partnership with Merck & Co., (known as MSD outside the United States and Canada), assessing a cognition therapy candidate in an ongoing Phase 1 program, which entered clinical development and triggered a US$10 million milestone payment last year,” added Dr. Rathjen. “This deal has a potential value of up to US$506 million in terms of the upfront payments, R&D payments and milestone payments, plus additional annual royalties on net sales of licensed drugs. Both the MSD partnership and our drug discovery programs reflect the robustness of Bionomics’ pipeline.”
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