Mereo BioPharma Reports on Recent Program Developments and Provides Financial Update

LONDON, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases, today provided an update on recent program developments and third quarter 2023 financial information.

Recent Program Developments

Setrusumab (UX143)

On October 14, 2023, Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) and Mereo BioPharma Group plc (“Mereo” or the “Company”) announced interim data from the Phase 2 portion of the Phase 2/3 Orbit study demonstrating that treatment with setrusumab (UX143) achieved a 67% reduction in annualized fracture rate in patients with osteogenesis imperfecta (OI) with at least 6 months of follow-up and continues to demonstrate ongoing and meaningful improvements in lumbar spine bone mineral density (BMD). The Phase 3 portion of the study is currently enrolling approximately 195 patients at 50 sites across 12 countries.

Alvelestat (MPH-966)

University of Alabama at Birmingham (UAB) and the Company are reporting on the ATALANTa study, a multi-center, double-blind, placebo-controlled, proof-of-concept investigator-led study run by Professor Mark Dransfield, Director of the Division of Pulmonary, Allergy and Critical Care, UAB, in collaboration with Mereo. ATALANta investigated the safety and efficacy of alvelestat 120 mg, or matched placebo, twice daily, for 12 weeks in a broad range of individuals with Alpha-1 Antitrypsin Deficiency-Associated Lung Disease, including subjects with less severe phenotypes (Pi*SZ) than were enrolled in the Company-sponsored ASTRAEUS Phase 2 study, and those receiving augmentation therapy. The study randomized 63 patients, 32 in the 120 mg alvelestat arm (44% on augmentation therapy) and 31 in the placebo arm (48% on augmentation therapy).

The results demonstrated with the 120 mg dose of alvelestat (the lower dose used in the Phase 2 ASTRAEUS study) are consistent with those observed in ASTRAEUS on blood neutrophil elastase activity and changes in the biomarkers desmosine and Aα-val³⁶⁰. The data from ATALANTa also show the significant effect of alvelestat on the SGRQ-activity domain in patients not on augmentation (p=0.0106 versus placebo).

There was no difference in the proportion of patients with treatment-related Adverse Events (AEs) between the alvelestat and placebo arms. There were no Serious Adverse Events (SAEs) and no Adverse Events of Special interest (AESIs) of liver, QTC prolongation or neutropenia observed. AESIs of infection were more frequent in the placebo arm, driven by an increased number of acute exacerbations of COPD (one in the alvelestat arm in a patient on augmentation, and seven exacerbations in the placebo arm in seven patients, five of whom were on augmentation). There were two discontinuations in the alvelestat group due to mild and moderate headache. The data demonstrate that the 120 mg dose of alvelestat is safe on top of augmentation and support Mereo’s selection of the 240 mg dose to be studied in the planned Phase 3 pivotal trial. Additional data are expected to be presented by UAB at future medical conferences.