LONDON, Oct. 17, 2022 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO), (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational oral neutrophil elastase inhibitor, alvelestat (MPH-966). Mereo intends to have an End-of-Phase 2 meeting with the FDA to discuss the design of a registration-enabling study for alvelestat as a treatment for AATD-associated lung disease, including the potential opportunity for an accelerated approval pathway, around the end of the year.
Mereo Biopharma announced topline results from the phase 2 ASTRAEUS study evaluating its oral neutrophil elastase (NE) inhibitor, alvelestat (MPH966) versus placebo in patients with severe alpha-1 antitrypsin deficiency-associated emphysema. The trial reached its primary efficacy endpoints, demonstrating a statistically significant change from baseline on blood biomarkers of alpha-1 antitrypsin deficiency (AATD) lung disease activity compared to baseline and placebo.
LONDON and REDWOOD CITY, Calif., Aug. 25, 2020 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH), “Mereo” or “the Company”, a clinical-stage biopharmaceutical company focused on oncology and rare diseases, today announced the initiation of a Phase 1b/2 placebo-controlled clinical trial to evaluate the safety and efficacy of alvelestat in hospitalized, adult patients with moderate to severe COVID-19 respiratory disease. Alvelestat is a novel, oral small molecule designed to inhibit neutrophil elastase (NE), a key enzyme involved in the destruction of lung tissue. Alvelestat is already being investigated by Mereo in a Phase 2 proof-of-concept clinical trial in patients with alpha-1 antitrypsin deficiency (“AATD”).
Mereo BioPharma has lost Celgene as a partner for anti-TIGIT drug etigilimab, one of two drugs acquired when Mereo merged with OncoMed Pharma earlier this year.