brexanolone extended release (BRII-296) / Brii Biosci - LARVOL DELTA

A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD) (clinicaltrials.gov) - P2 | N=11 | Completed | Sponsor: Brii Biosciences Limited | Active, not recruiting ➔ Completed | N=24 ➔ 11 | Trial completion date: Jun 2024 ➔ Mar 2024 | Trial primary completion date: Jun 2024 ➔ Mar 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD) (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: Brii Biosciences Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD) (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Brii Biosciences Limited | Phase classification: P2a ➔ P2

Phase classification • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD) (clinicaltrials.gov) - P2a | N=24 | Recruiting | Sponsor: Brii Biosciences Limited

New P2a trial • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

BRII-296 Demonstrates a Favorable Safety Profile for Sedation - Results from a Phase 1 Study of Safety, and Pharmacokinetics of BRII-296, an Extended-Release Injectable Formulation of Brexanolone in Healthy Adult Subjects (ASCP 2023) - "PK and safety profile in male and female healthy volunteers support further assessment of BRII-296 in PPD patients. No excessive sedation or loss of consciousness was observed. SSS median scores were normal across all cohorts with two isolated reports of sleepiness."

Clinical • Late-breaking abstract • P1 data • PK/PD data • CNS Disorders • Depression • Psychiatry • Vertigo

Brii’s COVID-19 antibody cocktail remains active against variants, expects Q4 data readout (FierceBiotech) - "'Our antibody cocktail remains active against most of the major variants of the virus: Delta, Beta, those key variants,' said Rogers Luo, president and general manager of Greater China for Brii. The phase 3 trial is ongoing and still recruiting patients in South Africa, Brazil, Argentina, U.S. and likely to enter India, as well...Brii expects a phase 3 data readout in the fourth quarter of this year...Brii has a phase 1 trial for BRII-296, which is being tested in patients with post-partum depression. The biotech expects top-line results by the end of this year, and Brii is also working on developing the drug for major depressive disorder."

P1 data • P3 data • Preclinical • Trial status • CNS Disorders • Depression • Infectious Disease • Major Depressive Disorder • Novel Coronavirus Disease • Postpartum Depression