Boosted by high-tech headband, Gate tests depression drug
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Depression is desperate for better treatments, and close to 100 patients will soon test a new drug developed in Indianapolis—combined with a high-tech headband. The Phase 2 clinical study will evaluate Gate Neurosciences’ lead drug, which uses a precision medicine approach.
The Indianapolis-based startup says it’s a sharp contrast to the current “trial and error” approach of blanket prescribing traditional drugs that may not work for weeks and often aren’t effective. The study could deliver more insight than ever before, because patients will wear a cutting-edge headband that analyzes—within hours—how their brainwaves respond.
In the same way that precision medicine has revolutionized cancer treatment by analyzing the unique biology of the patient’s tumor to find the best treatment, precision medicine could also radically improve how patients are treated for depression and other central nervous system (CNS) disorders by analyzing certain biomarkers.
“The brain is the most complex organ in the universe, so it’s been really challenging to understand what’s going on in psychiatric diseases…and the differences between patients,” says Gate Neurosciences Head of Corporate Development Rob Houghtaling. “Being able to get patients on the right treatment sooner that may be more effective for them—that’s going to be especially impactful in depression, where the current treatment paradigm is really based on trial and error.”
In the coming months, Gate will launch a Phase 2 clinical study of its rapid-acting, once-weekly oral medication to treat major depressive disorder, called zelquistinel. Gate says the main goal of the study is to better understand how patients’ mood, evaluated by a psychiatrist, responds week to week while taking zelquistinel.
The study, expected to enroll Hoosiers, could give Gate leaders more understanding than ever before of the drug’s impact by adding a new layer of technology: the Dreem 3S headband device. Developed by Boston-based MIT spinoff Beacon Biosignals, the FDA-cleared headband captures and analyzes EEG data, which “is basically a measure of brain wave activity,” says Houghtaling.
“EEG is just one biomarker to enable precision medicine in CNS disorders,” says Houghtaling. “There’s been a lot of advances in the past five years or so in capturing these waves, understanding how the wave patterns might be different between certain patient types and how new therapies [like zelquistinel] might impact your…brain wave patterns.”
Houghtaling explains the specifics of how Gate will use the Dreem headband in its Phase 2 study of zelquistinel.
Major advances in hardware also attracted Gate to use the headbands in the upcoming study; Houghtaling says the Dreem device can be worn comfortably at home and even while sleeping. Paired with the patient’s smartphone, the device will also collect highly scientific sleep measures as part of the study.
“A lot of that [sleep monitoring] data is helpful because there’s such a strong association between psychiatric disorders like depression and how well you sleep,” says Houghtaling.
Through a collaboration with Beacon Biosignals, every patient enrolled in the study will use the Dreem headband. The device could even reveal if zelquistinel has a near-immediate impact on patients’ brainwaves; when they visit the clinic for the weekly medication, the patients will wear the headband immediately before and after each dose.
“A secondary objective [of the study] is using EEG to see, if patients are feeling better, how does that correspond with what we’re capturing with the Dreem device?” says Houghtaling. “If we can use all the data we’re capturing to better treat patients, that’s really a cherry on top.”
The new level of data is expected to uncover a better understanding of biomarkers in depression, which could eventually give doctors a much clearer picture of how to best treat each patient individually.
“Our vision is that, one day, psychiatrists will be able to administer a biomarker tool, like an EEG device, in their office and better understand disease state and what type of therapy a patient might be a great candidate for. And as the patient is receiving a new therapy, be able to quickly understand whether they’re responding to it or not,” says Houghtaling. “Ultimately, this would improve the care of patients across neuropsychiatry.”
Additionally, Houghtaling says the study could help reveal applications for zelquistinel beyond depression.
“It is a compound that enhances synaptic plasticity and synaptic function. Synapses are how neurons communicate and connect with each other, so that has a lot of applications in other diseases, particularly schizophrenia, Alzheimer’s cognition, among others.”
Houghtaling says the study could help reveal applications for zelquistinel beyond depression.
As the company heads toward the clinical trial, Houghtaling said Gate Neurosciences is generating momentum, especially after moving its headquarters to the Indiana Biosciences Research Institute at 16 Tech near downtown Indy.
“One of the great things about moving our headquarters closer to downtown is being closer to Lilly and the Lilly network and really having a more close-knit biotech ecosystem with the IBRI,” he said. “We share a mutual interest in precision neuropsychiatry as the future of treatment of neuroscience diseases.”