CNS breakthrough!

On January 17, 2022, Soyuan Bio, a leading company in precision medicine, announced that the U.
S.
FDA approved the international Phase IIb clinical trial of Soyuan Bio’s first-in-class drug DB104 (liafensine) against refractory depression (TRD).
IND application
.
Suoyuan Bio will initiate this international Phase IIb clinical trial based on FDA approval to evaluate the safety and efficacy of DB104 in TRD patients
.
This clinical trial is the third international clinical trial carried out by Soyuan Bio after DB102 lymphoma international phase III and glioma clinical phase III, and will also be the first biomarker to be carried out in the field of the central nervous system (CNS).
guided clinical trials
.
DB104 is a world-first drug that specifically inhibits the reuptake of serotonin, norepinephrine, and dopamine, which play an important role in depression
.
Liafensine was originally developed by BMS/AMRI.
In the more than ten clinical trials that have been completed, DB104 has demonstrated a good safety profile, and no discontinuation due to adverse events has occurred
.
Soyuan Bio acquired the global R&D, production and sales rights of Liafensine in 2017
.
Dr.
Xiaoxiong Lu, Chief Technology Officer of Suoyuan Bio, said: "Compared with the endless number of innovative drugs in the field of oncology, the progress of drug research and development in the field of CNS is much slower
.
The success of a series of innovative oncology drugs in the past decade is largely based on biomarkers.
However, in the CNS field, there are few successful cases of targeted screening of effective population through biomarkers
.
Soyuan Bio uses a unique DGM biomarker discovery platform to discover a new predictive biomarker DGM4 (Denovo Genomic Marker 4), which specifically predicts the efficacy of DB104 treatment in TRD patients
.
We are very pleased to be able to advance this international clinical trial under the guidance of biomarkers, based on today's trial-and-error approach to more scientific An effective personalized medicine approach to develop new drugs for TRD and bring changes to the CNS field with the help of precision medicine
.
"For the oncology and CNS fields with serious unmet clinical needs, Soyuan Bio currently has eight products that have been developed to the late clinical stage
.
Among them, DB102 (enzastaurin) is used for the first-line treatment of diffuse large B-cell lymphoma (DLBCL).
The international multi-center phase III clinical trial (ENGINE study) has completed the enrollment of all patients worldwide, and the international multi-center phase III clinical trial (ENGAGE study) of DB102 for the first-line treatment of glioblastoma (GBM) is recruiting patients globally.
In addition to DB102
and DB104, Soyuan Bio has recently announced its newly discovered first predictive biomarker DGM7 in the field of gene therapy, which specifically predicts recurrent high-grade glioma (HGG) patients receiving gene therapy Efficacy after DB107 (Toca 511/Toca FC) treatment
.