MPH.L Regulatory News (MPH)

Mereo BioPharma Announces Setrusumab 6-Month Phase 2b Data in Osteogenesis Imperfecta Selected for Late-Breaking Oral Presentation at the American Society for Bone and Mineral Research (ASBMR) 2019 Annual Meeting

12-month data on all patients enrolled in the study expected in Q4 2019

London and Redwood City, Calif., September 04, 2019 - Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH), "Mereo" or the "Company" or the "Group," a clinical stage biopharmaceutical company focused on rare diseases, today announces that the 6-month interim data from the open label arm of the Company's Phase 2b dose-ranging "ASTEROID" clinical study of setrusumab (BPS-804) in adults with Type I, III or IV osteogenesis imperfecta (OI) have been selected for a late-breaking oral presentation at the upcoming American Society for Bone and Mineral Research (ASBMR) 2019 Annual Meeting to be held from September 20-23 in Orlando, FL.

Details of the presentation are as follows:

Presentation Title: "Setrusumab for the Treatment of Adults with Osteogenesis Imperfecta: 6-Month Data from the Open-Label Treatment Arm of the Phase 2b ASTEROID Study"

Date: Friday, September 20, 2019

Time: 3:45PM - 4:00 PM EDT

Location: Orange County Convention Center, Valencia Ballroom B-D

Session: Rare Bone Diseases: Evaluation and Treatment

Abstract Number: 1040

Authors: Bettina M Willie,1,2 Elizabeth A Zimmermann,1,2 Francis H Glorieux,1,2 Ian Hodgson,3 Anthony Hall,3 Alastair MacKinnon,3 Muhammed K Javaid,4 Jay Shapiro5

Affiliations: 1. Shriners Hospitals for Children - Canada, Montreal, Canada 2. Department of Pediatric Surgery, McGill University, Montreal, Canada 3. Mereo BioPharma Group Plc, London, UK 4. Nuffield Department of Orthapaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK 5. Suburban Hospital, Betheseda, MD, USA

About the Phase 2b ASTEROID Study

ASTEROID is an ongoing, 12-month, randomized, double-blind, Phase 2b dose-finding study in 112 adults diagnosed with type I, III or IV Osteogenesis Imperfecta and a confirmed COL1A1/COL1A2 mutation who have fractured over the previous 5 years. Patients in the trial had not been treated with bisphosphonates in the previous 3 months or other anabolic or anti-resorptive medications in the previous 6 months. The primary endpoint of the study is change from baseline of Bone Mineral Density (BMD) of the radius (wrist) as measured by High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) with secondary endpoints of BMD using traditional two-dimensional dual-energy X-ray absorptiometry (DXA) measurement together with measurement of serum bone biomarkers.

In May 2019, Mereo reported positive early 6-month data from the open label arm of the study. Mereo expects to report 12-month data on all patients enrolled in the ASTEROID study in Q4 2019.

About Osteogenesis Imperfecta

Osteogenesis Imperfects (OI) is a rare genetic disorder that is characterized by fragile bones and reduced bone mass resulting in bones that break easily, loose joints and weakened teeth. In severe cases patients may experience hundreds of fractures in a lifetime. In addition, people with OI often suffer muscle weakness, early hearing loss, fatigue, curved bones, scoliosis, respiratory problems and short stature, leading to significant impacts on overall health and quality of life. The majority of cases of OI (estimated at approximately 90.0%) are caused by a dominant mutation in a gene coding for type I collagen, a key component of healthy bone. Current treatment of OI is supportive, focusing on minimizing fractures and maximizing mobility, but to date, there are no EMA or FDA approved treatments.

About Setrusumab

Setrusumab is a fully humanized monoclonal antibody that inhibits sclerostin, a protein which inhibits the activity of bone-forming cells. The mechanism of action of setrusumab could be particularly well suited for the treatment of OI and has the potential to become the first approved treatment option that could reduce fractures and improve OI patients' quality of life. In addition to evaluating setrusumab in adult OI patients, Mereo's Paediatric Investigation Plan (PIP) has been approved by the European Medicines Agency (EMA) and a study design has been agreed for a Phase 3 registration trial in children, based on a primary endpoint of fracture rate over a 12-month period. The Phase 3 study will be conducted in approximately 165 children aged 5-18 years old, with severe OI.

About Mereo BioPharma

Mereo BioPharma is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics that aim to improve outcomes for patients with rare diseases. Mereo's strategy is to selectively acquire product candidates for rare diseases that have already received significant investment from pharmaceutical and large biotechnology companies and that have substantial preclinical, clinical and manufacturing data packages. Mereo's existing portfolio consists of six clinical stage product candidates.

·; Setrusumab for osteogenesis imperfecta (OI). In October 2018, the Company announced completion of enrollment of 112 adult patients in a Phase 2b dose ranging study with initial positive 6-month open label data announced in May 2019 and top-line 12-month blinded dose ranging data expected in Q4 2019. A pediatric Phase 3 study design has also been approved by the EMA. Setrusumab has orphan designation in the U.S. and the EU and has been accepted into the PRIME and Adaptive Pathways in EU;

·; Alvelestat for alpha-1 antitrypsin deficiency (AATD). The Company has initiated a Phase 2 proof-of-concept clinical trial in patients with severe AATD in the United States and the EU and expects to report top-line data from this trial around the end of 2019;

·; Acumapimod for severe exacerbations of COPD. The Company announced positive Phase 2 data in May 2018 and recently announced the outline of the pivotal Phase 3 study including the primary and key secondary endpoints following the successful end of Phase 2 Type B meeting with the FDA;

·; Leflutrozole for hypogonadotropic hypogonadism (HH). The Company announced positive top-line Phase 2b data in March 2018 and positive results from the Phase 2b safety extension study in December 2018;

·; Navicixizumab has completed a Phase 1a single-agent clinical trial in patients with advanced solid tumors and is currently in a Phase 1b trial in combination with a standard paclitaxel regimen in patients with platinum-resistant ovarian cancer. This study recently completed enrollment and the Company has held a successful Type B meeting with the FDA outlining a path for Accelerated Approval; and

·; Etigilimab has completed a single-agent Phase 1a trial in patients with advanced or metastatic solid tumors and the Phase 1b combination study with nivolumab has fully enrolled and is currently in the safety monitoring phase. 

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