Circular Genomics, a developer of precision medicine diagnostics for a neurology and psychiatry announced Tuesday that the use of circular RNA (circRNA) biomarkers can predict patient response to the clinical depression drug Sertraline, one of the most common treatments for the mental health disorder. Data from the EMBARC (Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression) study, showed that the company’s approach of detecting brain-enriched circRNAs in whole blood could streamline the drug selection process for people with depression, who today often must try a number of different medications before finding one that is effective.
“We’re excited to announce the findings from the EMBARC study and the ways in which we expect it to shape the future of depression treatment,” said Nikolaos Mellios, co-founder and CSO of Circular Genomics. “While DNA-based pharmacogenomic tests are available, their ability to predict drug response or therapy monitoring is lacking and market adoption has been slow. With our new findings, we can work to end the guessing game mental health patients currently have to go through. When someone is already struggling with depression, the process of going on and off medications while finding the right antidepressant can be highly unpleasant at best and in some cases dangerous.”
First-line therapies for major depressive disorder are known to fail more than half of the time and in many cases it can take up to one-year to find an effective treatment for an individual. Circular Genomics takes a novel approach using circRNA as a biomarker, which is highly expressed in neural tissue and is increasingly associated with a number of neurological conditions. The company is developing its tests to not only help predict patient response to medication and aid clinicians in therapy selection, but to also monitor and validate treatment effectiveness in days to weeks rather than months.
The company noted that the results of the EMBARC study opens the possibility for more precise therapy selection, diagnosis, and patient stratification to inform drug discovery and development for new neurology treatments. “Our data suggests that predictive circRNAs detected in the blood are produced in the brain, where they are regulated via known biological mechanisms related to antidepressant response,” Mellios said.
Circular Genomics was founded in 2021 as a spin out of the University of New Mexico based on the research of Mellios and company co-founder Alexander Hafez focused on non-coding and circular RNA. In December 2021, the company received $4.5 million in seed funding co-led by Cottonwood Technology Fund III and Tramway Venture Partners along with Mountain Group Partners. It’s initial focus for leveraging circRNA as a biomarker is in depression, but the company also intends to expand into other neurologic disorders including Alzheimer’s disease, PTSD, and bipolar disorder.
In addition to the study results, the company also reported it will collaborate with the ANTaRES consortium (The Biomarkers of ANTidepressant RESponse: early indicators and novel targets), in an ongoing clinical study to discover early biomarkers and novel mechanistic targets of antidepressant response. The study includes well-characterized clinical samples and participant health records from psychiatric clinics in France with a goal of early identification of biomarkers predicting response to differential treatment outcomes. As the only commercial partner in the study, Circular Genomics will benefit by gaining access to the clinical samples to aid its ongoing product development efforts.
Leveraging these samples and the data from EMBARC, the company anticipates launch of its circRNA technology to provide therapy selection services via a CLIA LDT laboratory in early 2024.
