First Patient Dosed in the ENLIGHTEN Biomarker-Guided Global Clinical Trial of DB104 (Liafensine) for Treatment-Resistant Depression

SAN DIEGO, July 28, 2022 /PRNewswire/ -- Denovo Biopharma LLC ("Denovo"), a pioneer in applying precision medicine to the development of innovative therapies, today announced dosing of the first patient in its biomarker-guided global Phase 2b clinical trial (the "ENLIGHTEN" study) to assess the safety and efficacy of DB104 (liafensine) in patients with treatment resistant depression (TRD).  DB104 is a first-in-class triple reuptake inhibitor targeting transporters for dopamine, serotonin, and norepinephrine.  Denovo discovered a novel genetic biomarker for DB104 efficacy using its unique machine learning approach with whole genome sequencing to identify biomarkers that may be predictive of a patient's response to a specific medicine.  TRD has a major unmet need since approximately one-third of people receive inadequate benefit from at least two existing treatments for depression.

This randomized, double-blind, placebo-controlled global study is to enroll close to 200 patients. The primary outcome measure is the change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score in patients with or without the proprietary Denovo Genomic Marker 4 (DGM4)™ biomarker.  This TRD stuty has received Phase 2b permission from regulatory agencies in the US and China.

Larry Alphs, M.D., Senior Vice President at Denovo, said, "This global study utilizes Denovo's state-of-the-art biomarker discovery process that identified the novel DGM4 biomarker as predictive of patients who will respond to DB104. To our knowledge this is the first clinical study industry-wide that uses a genetic biomarker to predict a drug's efficacy in patients with a mental health disorder."

For more information on the DB104 ENLIGHTEN clinical study, visit https://clinicaltrials.gov/ct2/show/NCT05113771.

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 cha TRD. TRD is a chronic condition that places an ongoing emotional, functional, and economic burden on the individual, their loved ones, and society.

DB104 is a first-in-class triple reuptake inhibitor targeting transporters for dopamine, serotonin, and norepinephrine.  It was licensed from Albany Molecular Research, Inc. (NASDAQ: AMRI) following its return from Bristol-Myers Squibb, who had conducted two large phase 2b clinical trials in TRD.  More than 2000 subjects have been treated with DB104 to date.

Denovo Biopharma LLC is a clinical-stage biopharmaceutical company that uses novel biomarker approaches to executes efficient clinical trials in targeted patient populations to optimize the probability of successful trials. Denovo has 8 late clinical stage drugs in its pipeline addressing major unmet medical needs in oncology and CNS diseases, most of which are first–in–class drugs with global rights. Its first biomarker-guided trial for its lead asset DB102 (enzastaurin) has completed enrollment of patients with diffuse large B-cell lymphoma (DLBCL) in a Phase 3 clinical trial in the US and China, and enrollment is ongoing in a Phase 3 trial in glioblastoma (GBM). For additional information, please visit www.denovobiopharma.com.

Contact:
Michael F. Haller, Ph.D., Chief Business Officer
Denovo Biopharma LLC
[email protected]

SOURCE Denovo Biopharma LLC