Prescription digital therapeutics (DTx) company Blue Note is starting a large-scale, decentralised trial of two cancer therapies that it hopes will lead to regulatory approval from the FDA.
The company is working with Curebase on a trial that will recruit around 350 patients with cancer and will be run completely remotely, with no need for clinic visits. The study will examine the effects of using two DTx products targeting mental and physical health, as an add-on to standard cancer care.
“Patients living with cancer frequently experience stress, anxiety, and depression,” said Geoffrey Eich, Blue Note’s chief executive.
“Our collaboration with Curebase is exciting as it brings together our unique capabilities to expand our reach in recruiting for this new, fully virtual clinical trial.”
One of Blue Note’s DTx products – used to treat anxiety and depression in adults with acute myeloid leukaemia (AML) who are hospitalised for a regimen of high-intensity induction chemotherapy – was awarded a breakthrough designation by the FDA earlier this year.
At the time, the digital health company said the status recognised the potential of the DTx for the thousands of patients diagnosed with AML every year in the US who can find it challenging to cope with both the symptoms of the cancer and the debilitating side effects of treatment.
Curebase’s decentralised trial platform will be used to recruit and screen participants, obtain consent, and then guide them through the reporting and activities required for the study from their own homes. The company also takes responsibility for running the virtual trial.
According to Blue Note, the approach will enable it to access patient populations that have been underrepresented in traditional site-based clinical studies, regardless of their location.
In 2020, Blue Note formed an alliance with Memorial Sloan Kettering Cancer Centre in the US to develop an app that can be used by patients who are living in fear of their cancer. Drawing on this, it is developing a range of DTx products for specific cancer settings, including for breast and lung cancer patients.
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