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On June 15, 2021, Sage Therapeutics and Biogen jointly announced that the potential "first-in-class" oral drug zuranolone (SAGE-217/BIIB125) for patients with major depression (MDD) is in a phase 3 clinical trial The primary end point was reached
.
This is a new generation of gamma-aminobutyric acid (GABAA) receptor allosteric modulator
MDD is a common and serious mental illness and one of the biggest causes of disability worldwide
.
It is estimated that more than 250 million people worldwide suffer from MDD
For the past 60 years, monoamine-based antidepressants have been the standard treatment for long-term treatment of MDD.
They are based on daily administration and require continuous use to maintain efficacy
.
Zuranolone is an innovative oral potential "first-in-class" drug administered once a day for two weeks and is being developed for the treatment of MDD and postpartum depression (PPD)
▲Zuranolone molecular structure (picture source: Ed (Edgar181), Public domain, via Wikimedia Commons)
Bojian reached a cooperation with Sage Therapeutics in November last year to jointly develop zuranolone and SAGE-324 for the treatment of essential tremor and other neurological diseases
.
In the pivotal, randomized, double-blind, placebo-controlled phase 3 clinical trial WATERFALL, 90.
3% of patients in the trial group and 87.
4% of patients in the placebo group completed the study
.
On the first day before dosing, the average baseline HAMD-17 scores of the experimental group (n=268) and placebo group (n=269) were 26.
▲Zuranolone reached the primary endpoint in the Phase 3 clinical trial WATERFALL (picture source: reference [1])
The test results showed that rapid onset was observed on the 3rd, 8th, and 12th day, and there was a significant difference in the HAMD-17 score
.
On day 15, zuranolone reduced the patient's HAMD-17 score by 1.
In this study, zuranolone was generally well tolerated and showed safety characteristics consistent with previous clinical studies
.
The incidence of treatment-related adverse events (TEAE) in the experimental group was 60.
Note: The original text has been deleted
Reference materials:
[1] MDD-301B WATERFALL Topline Data.
[2] Sage Therapeutics and Biogen Announce Positive Pivotal Phase 3 Results for Zuranolone, an Investigational Two-Week, Once-Daily Therapeutic Being Evaluated for Major Depressive Disorder.
