Mereo BioPharma Group plc (MREO) has gained nearly 300% in the last 4 trading days as it gears up for a couple of important clinical trial catalysts in the coming year.
The Company’s lead drug candidate is Setrusumab, a potential treatment for osteogenesis imperfecta, also known as brittle bone disease. Setrusumab was acquired from Novartis in 2015.
Osteogenesis imperfecta, or OI, is a rare genetic disorder characterized by bone fragility leading to fracture and bone deformity, chronic bone pain and reduced mobility. (Source: NCBI). An estimated 20,000 to 50,000 people in the United States have osteogenesis imperfecta, according to reports. To date, there are no approved treatments for OI.
In a phase IIb study, which evaluated Setrusumab in adults with Type I, III or IV osteogenesis imperfecta, dubbed ASTEROID, a trend of reduction in fractures was observed in the high dose cohort. The results of this study were reported last month.
The primary endpoint of the ASTEROID study was change in Trabecular Volumetric Bone Mineral Density (Tr vBMD) of the radius (wrist) over baseline after 12 months of treatment. However, this was not met but an increase in total vBMD at the wrist, a secondary endpoint of the study, was observed and reached statistical significance in the medium and high dose cohorts, according to the Company.
Despite the ASTEROID study not meeting the primary endpoint, the Company is confident of Setrusumab’s potential and plans to advance the compound to a pediatric pivotal trial for the treatment of Osteogenesis Imperfecta.
Mereo’s Paediatric Investigation Plan (PIP) has been approved by the European Medicines Agency and a study design has been agreed for a pivotal study in children with OI, based on a primary endpoint of fracture rate over a 12-month period.
The pivotal study will be conducted in approximately 165 children aged 5 to less than 18 years old, with OI, initially in EU and Canada, with potential expansion into the U.S. following planned discussions with the FDA. This pivotal trial has fractures and fracture reduction as its primary endpoint.
The other investigational drugs in the pipeline are:
— MPH-966, (Alvelestat) an oral neutrophil elastase inhibitor, being explored for the potential treatment of alpha-1 antitrypsin deficiency (AATD), under a phase II study. Mereo expects to report top-line data from this study in mid-2020 and if the results are positive, will seek regulatory advice on the design of a pivotal trial. This compound was acquired from AstraZeneca in 2017.
— Acumapimod, a phase III-ready compound, for Acute Exacerbations of Chronic Obstructive Pulmonary Disease, or AECOPD.
— BGS-649 (leflutrozole) that has completed phase IIb development as a first-line therapy for the treatment of obese men with hypogonadotropic hypogonadism.
— Navicixizumab (OMP-305B83), a phase II-ready compound, for Advanced Platinum-Resistant Ovarian Cancer.
— Etigilimab, which has completed a phase 1a/b trial in advanced solid tumors.
The Company is seeking partnering opportunities for its compounds. As of June 30, 2019, Mereo had cash of £36.1 million.
Mereo BioPharma is the result of the merger between NASDAQ-listed OncoMed and London Stock Exchange’s AIM market-listed Mereo BioPharma, the combination of which was completed in April 2019. The combined company is dual-listed on the NASDAQ and AIM market.
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