Focused CNS Pipeline
Bionomics is developing novel, allosteric ion channel modulators designed to transform the lives of patients suffering from serious central nervous system (“CNS”) disorders with high unmet medical need.
Ion channels serve as important mediators of physiological function in the CNS and the modulation of ion channels influences neurotransmission that leads to downstream signaling in the brain. The α7 nicotinic acetylcholine (“ACh”) receptor (“α7 receptor”) is an ion channel that plays an important role in driving emotional responses and cognitive performance. Utilizing our expertise in ion channel biology and translational medicine, we are developing orally active small molecule negative allosteric modulators (“NAMs”) and positive allosteric modulators (“PAMs”) of the α7 receptor to treat anxiety and stressor-related disorders and cognitive dysfunction, respectively.
Our expertise and approach have been validated through our June 2014 research collaboration and license agreement with Merck & Co. for our α7 receptor PAM program, which targets a receptor that has garnered significant attention for treating cognitive deficits. This partnership enables us to maximize the value of our ion channel and chemistry platforms and develop transformative medicines for patients suffering from cognitive disorders such as Alzheimer’s disease.
Bionomics is advancing its lead product candidate, BNC210, an oral, proprietary, selective NAM of the α7 receptor, for the acute treatment of Social Anxiety Disorder (“SAD”) and chronic treatment of Post-Traumatic Stress Disorder (“PTSD”). There remains a significant unmet medical need for the over 22 million patients in the United States alone suffering from SAD and PTSD.
Bionomics expects to initiate a Phase 2 trial for BNC210 for the acute treatment of SAD by the end of 2021 and currently anticipate reporting topline data by the end of 2022. We have initiated our Phase 2b ATTUNE trial, a randomized, placebo-controlled study to evaluate BNC210 for the treatment of PTSD and we expect to report topline data in the first half of 2023.
In June 2014, Bionomics entered into a research collaboration and license agreement with Merck to develop α7 receptor Positive Allosteric Modulators (PAMs) targeting cognitive dysfunction associated with Alzheimer’s disease and other central nervous system conditions.
The Merck collaboration currently includes two candidates which are PAMs of the α7 receptor that are in early-stage Phase 1 safety and biomarker clinical trials for treating cognitive impairment.
Bionomics’ CNS pipeline includes two earlier stage small molecule discovery programs targeting ion channels and represent additional opportunities for clinical programs and future partnering. These programs are at a similar stage at which the α7 receptor PAM program was licensed under the 2014 Merck License Agreement.
The first of these programs has developed two patented series of small molecule Kv3.1/3.2 potassium channel activators for the potential treatment of cognitive deficits and negative symptoms/social withdrawal in schizophrenia and autism spectrum disorders.
The second program has developed three patented series of small molecule inhibitors with functional selectivity for Nav1.7 and Nav1.8 voltage gated sodium ion channels for the potential treatment of chronic pain without the liability of addiction associated with opioid treatment.