Blue Note Therapeutics and University of California Los Angeles Jonsson Comprehensive Cancer Center Commence a Single-Arm Open-Label Phase 2 Study for BNT001
Blue Note Therapeutics and the University of California Los Angeles (UCLA) Jonsson Comprehensive Cancer Center have commenced a single-arm, open-label, Phase 2 study for BNT001. BNT001 is Blue Note’s lead prescription digital therapeutic (PDT) candidate for the treatment of symptoms of anxiety and depression related to cancer in adult patients. The investigator-initiated Phase 2 study will primarily assess the practical feasibility of integrating BNT001 into the care of stage I-III breast or lung cancer patients and evaluate patients’ acceptability of the product. The trial will also collect preliminary data regarding the efficacy of the intervention by measuring improvements in patients’ reported symptoms of stress. The trial is currently recruiting.
In June 2020, Blue Note received Breakthrough Device Designation for BNT001 from the U.S. Food and Drug Administration (FDA) by establishing that it offers a potentially more effective treatment for cancer-related distress delivered via breakthrough technology. As a digital therapeutic, BNT001 helps to address the limitations of current face-to-face treatment methods through improved access to psychosocial behavioral therapy.
For more information about the study, visit https://ClinicalTrials.gov (NCT04705025).
For information regarding the UCLA Jonsson Comprehensive Cancer Center, visit https://cancer.ucla.edu/.