Mereo BioPharma Group, a UK-based specialty biopharma company, has completed patient enrolment for a phase 2b clinical trial of BPS-804 (Setrusumab) intended for the treatment of osteogenesis imperfect (OI), it was reported yesterday.
The product has received Orphan Drug Designation from both the US Food and Drug Administration (FDA) and the European Medicines Agency for the product for OI, a form of brittle bone disease.
The investigational OI drug has also been accepted into the European Medicines Agency's Adaptive Pathways Program and was offered PRIority MEdicines (PRIME) designation.
The trial is a multi-centre, randomised, double-blind, dose-finding phase 2b study named ASTEROID and will assess the drug in a total of 112 adult patients across the United States and Europe, according to the company.
FDA approval streamlines access to Bristol Myers Squibb CAR T cell therapies
Emmaus Life Sciences' Endari label enhancements receive US FDA approval
Accord Healthcare introduces Dehydrated Alcohol Injection for cardiovascular indications
CARsgen Therapeutics' satri-cel NDA accepted by Chinese regulator
Sanofi receives FDA orphan drug designation for riliprubart in transplant rejection
Hoth Therapeutics reports positive interim results for HT-001 topical therapy
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Hemab Therapeutics presents bleeding disorder clinical and preclinical data at ISTH 2025 Congress