Mereo BioPharma Group plc

Mereo BioPharma Group plc is a biopharmaceutical company that develops innovative treatments for rare diseases. The company has a portfolio of product candidates in late-stage clinical development. Its late-stage rare disease product candidates include setrusumab, which treats osteogenesis imperfecta (OI), and alvelestat, for severe alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD). Setrusumab has received orphan designation for OI from the European Commission (EC) and the FDA, PRIME designation from the EMA, and Breakthrough Therapy designation and rare pediatric disease designation from the FDA. Alvelestat has received orphan designation for AATD from the EC and the FDA, and Fast Track designation for the treatment of AATD-LD from the FDA. Mereo BioPharma also has an early-stage rare disease program, vantictumab, which targets autosomal dominant osteopetrosis Type 2 (ADO2), another bone disease. The global development of vantictumab is funded and led by its partner, āshibio, with Mereo BioPharma retaining European commercial rights. The company's strategy involves acquiring and developing rare disease product candidates that have already received significant investment from larger pharmaceutical and biotechnology companies and possess substantial pre-clinical, clinical, and manufacturing data. Since its formation in March 2015, Mereo BioPharma has acquired all of its clinical-stage product candidates, three of which are for rare diseases. The company has completed large, randomized Phase 2 clinical trials for four product candidates and the Phase 1b portion of a Phase 1b/2 for a fifth. Mereo BioPharma and its partner Ultragenyx recently announced results from two Phase 3 studies for setrusumab in OI.