Newswise — SAN DIEGO, March 6, 2023 /PRNewswire/ -- Denovo Biopharma LLC ("Denovo"), a pioneer in applying precision medicine to the development of innovative therapies, set up a gene registry web portal and invites people who suffer from treatment-resistant depression (TRD) to visit www.iMatchDepression.com to help identify whether they or someone they know may be eligible to participate in a biomarker-guided global Phase 2b clinical trial (the "ENLIGHTEN" study).
Two-thirds of people with depression do not benefit from their first antidepressant treatment, and more than 30% of people fail to adequately respond following multiple treatment attempts. Denovo is trying to address this unmet need with a novel precision medicine approach. Denovo identifies a specific DNA biomarker, called Denovo Genomic Marker 4 (DGM4™); people who have this biomarker have increased likelihood of responding to an investigational medication called liafensine. However, it brings a unique challenge to the study enrollment as no more than 20% of the patients carry the DGM4 biomarker. To overcome this difficulty, Denovo has created a novel gene registry platform which allows potential participants to have their DGM4 status tested without leaving their home by simply submitting their saliva sample to a testing lab, at no cost. People with the DGM4 biomarker may be eligible to join the ENLIGHTEN clinical study, but there is no obligation to do so. This may be the first precision medicine based clinical study in the CNS field.
Matthew A. Spear, M.D., Chief Medical Officer at Denovo, said, "At www.iMatchDepression.com people can register, obtain a test kit for the DGM4 biomarker, and learn more about joining our innovative biomarker-guided ENLIGHTEN clinical study for TRD. We thank everyone in advance for contributing to this effort to potentially develop a precision medicine for TRD."
For more information on the iMatchDepression registry and the DB104 ENLIGHTEN clinical study, visit www.imatchdepression.com and www.enlightendepressionstudy.
About Treatment-Resistant Depression
Major depressive disorder (MDD) afflicts more than 15 million people in the US in any given year. Approximately one-third of people with MDD do not respond adequately to at least two different antidepressants that have been given at adequate doses and duration and are considered to have treatment-resistant depression (TRD). TRD is a chronic condition that places an ongoing emotional, functional, and economic burden on the individual, their loved ones, and society.
About the Phase 2b ENLIGHTEN clinical study
The ENLIGHTEN clinical study assesses the safety and efficacy of liafensine in patients with treatment resistant depression (TRD). Liafensine is a first-in-class triple reuptake inhibitor targeting transporters for dopamine, serotonin, and norepinephrine. Using a unique machine learning technology combined with a whole genome sequencing to identify biomarkers Denovo discovered a novel genetic biomarker that may identify persons who are likely to respond to liafensine. This randomized, double-blind, placebo-controlled global study will enroll approximately 200 patients. The primary outcome measure for this study is the change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score in patients with or without the proprietary DGM4 biomarker. This TRD study has received Phase 2b permission from regulatory agencies in the US, Canada, and China.
About DB104 (Liafensine)
DB104 is a first-in-class triple reuptake inhibitor targeting reuptake transporters for dopamine, serotonin, and norepinephrine. It was licensed from Albany Molecular Research, Inc. following its return from Bristol-Myers Squibb, who had conducted two large phase 2b clinical trials in TRD. To date more than 1700 subjects have been treated with DB104.
About Denovo Biopharma
Denovo Biopharma LLC is a clinical-stage biopharmaceutical company that uses novel biomarker approaches to execute efficient, patient-targeted clinical trials to optimize the probability of trial success. Denovo has 8 late clinical stage drugs in its pipeline. These address major unmet medical needs in oncology and CNS diseases, most of which are first-in-class drugs with global rights. It has two biomarker-guided late-stage ongoing trials -- a Phase 3 trial in glioblastoma (GBM) for its DB102 asset and a Phase 2b trial for its DB104 asset. For additional information, please visit www.denovobiopharma.com.
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