The current lack of objective biomarkers presents a real challenge for researchers developing treatments for psychiatric and neurological diseases. But now, a partnership that combines Calyx’s clinical trial imaging expertise and Ceretype’s novel functional MRI (fMRI) platform enables trial sponsors to overcome this challenge and see the objective outcome of a drug on patients with psychiatric and other neurological disorders.
Here we talk with Ceretype CEO and co-founder, Emily Stern about how fMRI can improve CNS clinical trials and how the partnership with Calyx Medical Imaging is greater than the sum of its parts.
What does Ceretype do?
Ceretype is focused on translating fMRI scanning into clinically useful products. For a long time, fMRI has been a powerful tool for research in academic medicine, enabling investigators to learn more about normal brain function and dysfunction in disease settings. However, the methodology hasn’t translated out of academia for several reasons, which Ceretype has now addressed.
An important part of Ceretype’s roadmap is to use fMRI technology to improve the outcomes of CNS clinical trials, an area in which we can immediately supply critical biological insights about the brain and how treatments impact its function.
What is the difference between fMRI and traditional MRI?
fMRI allows us to look at function in addition to structure. It’s a non-invasive tool that measures activity across the entire brain. It’s based on the fact that when nerve cells are active in specific areas of the brain there’s a local increase in blood flow and related changes in blood oxygenation. These result in biochemical changes that fMRI can measure.
With fMRI, we can measure changes in activity that occur while the brain is actively performing a task or at rest . For example, we can see the areas responsible for deciding to move a hand. We can see the areas responsible for speech, hearing/interpreting language, or problem-solving. We can even see the areas that underly emotions. And we can measure and localize abnormal activity associated with brain disease in psychiatry and neurology, or in response to treatment.
Additional Resources
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How can fMRI help clinical research and patients?
fMRI has already been a powerful tool in academia, helping us understand the neurobiology that underlies psychiatric and neurologic disorders. But it hasn’t scaled due to several technical hurdles. Ceretype has addressed these challenges systematically to create a scalable, easily deployable, reliable, reproducible, and compliant platform, enabling us to deploy fMRI widely in multi-site clinical trials.
Until now, psychiatry hasn’t had any biological measures to inform drug development or help with patient care, unlike virtually every other area of medicine. So, bringing this technology to psychiatric and other CNS-related clinical trials will be helpful in several ways.
For example, we can objectively measure the impact of an intervention on specific brain networks, allowing us to identify the therapeutic mechanism of action. We can subtype and stratify patients based on criteria such as whether they’ve responded to treatment or not.
We can also de-risk and accelerate trials by identifying more homogeneous patient groups based on brain activity patterns. For example, an important factor in the high failure rate of depression or schizophrenia trials is the heterogeneous biology that makes it unlikely that a drug will work in every patient. Hence, being able to enrich or to stratify the patient samples based on their brain activity patterns can increase the likelihood that the trial will reach significance and potentially get there more quickly. This could be very powerful in psychiatric drug development which, until now, has relied solely on subjective endpoints.
Is there evidence to prove fMRI is beneficial to clinical trials?
Our team has published numerous papers showing our methodology, which includes a technique called multi echo fMRI, significantly increases the signal to noise ratio by a factor of up to four times. The result is substantially more accurate, reliable, and reproducible fMRI. This is a prerequisite for multi-site clinical trials.
We’ve also shown that fMRI can inform our understanding of the neurobiology of multiple neuropsychiatric diseases, such as depression, schizophrenia and post-traumatic stress disorder. We and others have demonstrated that fMRI can show how the brain is modulated in response to different therapies. So, there is a lot of evidence to indicate that this technology will bring value to trials. And having this biological evidence of drug effects, particularly in psychiatry, will be a huge step forward and something that we’re very excited about.
What is the benefit of Calyx’s partnership with Ceretype?
Ceretype and Calyx are truly very complementary. While Ceretype brings this powerful new technology to inform, de-risk, and accelerate clinical trials, Calyx has a mature infrastructure for implementing the technology seamlessly into trial workflows. And Calyx is prescient in seeing the value of bringing these types of technologies to clinical trials. I think that together we’re more than the sum of our parts and we’ll accomplish great things together.
