Denovo Biopharma LLC Announces FDA Approval
of IND to Initiate First Biomarker‑Guided Global CNS Clinical Trial for Treatment-Resistant
Depression (TRD)
SAN DIEGO, January 31, 2022 -- Denovo
Biopharma LLC (“Denovo”), a pioneer in applying precision
medicine to the development of innovative therapies, today announced that the FDA
has authorized the company’s investigational new drug (IND) application of DB104
(liafensine) for treatment-resistant depression (TRD)
to proceed, which enables Denovo to start a global Phase 2b
clinical trial to assess the safety and efficacy of liafensine in patients with
TRD. This will be the third potentially pivotal global trial that Denovo is conducting, and more importantly, may be the
first ever genetic biomarker-guided clinical trial conducted for central
nervous system (CNS) diseases.
Xiao-Xiong
Lu, PhD, Denovo’s Chief Technical Officer, said, “CNS
diseases are notoriously difficult to treat, and lack of precision medicines
may contribute to the modest success in developing innovative drugs in this
area. Denovo used its unique biomarker platform to
identify a novel predictive biomarker named Denovo
Genomic Marker 4 (DGM4™), which is highly associated with clinical response to
liafensine in patients with TRD. We are excited to launch this biomarker-guided
TRD trial that may provide a scientific, personalized medicine approach rather
than the trial-and-error method that is typically used today. This could potentially be a game‑changer for the field of
CNS drug development.”
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 of
adequate dose and duration in the current depressive episode 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 Denovo Biopharma
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 dieseases, 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).
In addition to Denovo-discovered biomarkers for DB102
and DB104, Denovo also announced
recently the discovery of a novel biomarker for its gene therapy program
DB107 (Toca 511/Toca FC)
for recurrent high-grade glioma. For additional information, please visit www.denovobiopharma.com.
Contact:
Michael F. Haller, Chief Business Officer
Denovo Biopharma LLC
mhaller@denovobiopharma.com