Brii Biosciences Limited, a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, announced top-line results from a phase 1 study evaluating its long-acting, single-injection therapy, BRII-296, in development for the treatment of postpartum depression (PPD). These data show that a single treatment via intramuscular (IM) injection of 600 mg of BRII-296 achieved dose linearity, early drug absorption, gradual and extended release profiles without the need for dose titration or tapering, providing confidence that this dose has potential to achieve clinical efficacy in the treatment of PPD. The selected dose regimen will be evaluated in a phase 2 clinical trial that is expected to begin this year.
BRII-296 acts as a novel gamma-aminobutyric acid A (GABAa) receptor positive allosteric modulator (PAM) with a unique long-acting formulation that does not require cessation of breastfeeding and enables the drug to be effective for weeks after the patient leaves the injection appointment. It is designed to provide a rapid, profound and sustained reduction in depressive symptoms of PPD and may offer substantial clinically meaningful advantages over currently available treatment options for PPD.
