Denovo Biopharma LLC Announces FDA Approval of IND to Initiate Global First Biomarker-Guided CNS Clinical Trial for Treatment-Resistant Depression (TRD)

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SAN DIEGO, January 31, 2022 /PRNewswire/ — Denovo Biopharma LLC (“Denovo”), a pioneer in the application of precision medicine to the development of breakthrough therapies, today announced that the FDA has cleared the application of DB104 (liafensin) for company’s investigational new drug (IND) for treatment-resistant depression (TRD) to proceed, allowing Denovo to start a global Phase 2b clinical trial to assess the safety and efficacy of the liafensin in patients with TRD. This will be the third potentially pivotal global trial that Denovo is conducting and, more importantly, it could be the first-ever genetic biomarker-guided clinical trial conducted for central nervous system (CNS) diseases.

“This could potentially be a game-changer in the field of CNS drug development.”

Xiao Xiong LuPhD, CTO of Denovo, said, “CNS diseases are notoriously difficult to treat, and the lack of precision medicines may contribute to the modest success of innovative drug development in this area. Denovo has used its unique biomarker platform to identify a novel predictive biomarker named Denovo Genomic Marker 4 (DGM4™), which is strongly associated with clinical response to liafensin in patients with TRD We are excited to initiate this TRD guided trial by biomarkers which could provide a scientific and personalized approach to medicine rather than the trial-and-error method which is generally used today. This could potentially be a game-changer in the field of CNS drug development.

About Treatment Resistant Depression
Major depressive disorder (MDD) affects more than 15 million people in the United States each year. About one-third of people with MDD fail to respond adequately to at least two different antidepressants of adequate dose and duration in the current depressive episode and are considered to have treatment-resistant depression (TRD). TRD is a chronic disease that imposes a lifelong emotional, functional, and economic burden on the individual, their loved ones, and society.

About Denovo Biopharma
Denovo Biopharma LLC is a clinical-stage biopharmaceutical company that uses novel biomarker approaches to execute effective clinical trials in targeted patient populations to optimize the likelihood of trial success. Denovo has 8 late-stage clinical drugs in its pipeline addressing significant unmet medical needs in oncology and CNS diseases, most of which are premium drugs with global rights. Its first biomarker-guided trial for its lead asset DB102 (enzastaurine) has completed the enrollment of patients with diffuse large B-cell lymphoma (DLBCL) in a phase 3 clinical trial in the United States and China, and enrollment is underway in a phase 3 glioblastoma (GBM) trial. In addition to the biomarkers discovered by Denovo for DB102 and DB104, Denovo also recently announced the discovery of a new biomarker for its gene therapy program DB107 (Toca 511/Toca FC) for recurrent high-grade glioma. For more information, please visit www.denovobiopharma.com.

Contact:
Michael F. HallerEntrepreneur
Denovo Biopharma LLC
[email protected]vobiopharma.com

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