(RTTNews) - Mereo BioPharma Group plc (MREO), a clinical-stage biopharmaceutical company, provided an update on its lead programs for its rare-disease product candidates, setrusumab and alvelestat, along with revised cash-runway guidance.
Following the update, MREO is up 7% in the premarket at $0.70.
-Setrusumab (UX-143) For Osteogenesis Imperfecta
Setrusumab is a fully humanised monoclonal antibody being investigated for the potential treatment of osteogenesis imperfecta (OI), commonly known as brittle bone disease.
Mereo BioPharma and Ultragenyx are collaborating on the global development of setrusumab (UX-143) under a license agreement signed in December 2020.
Osteogenesis imperfecta (OI) is a group of rare systemic connective tissue disorders, most commonly caused by pathogenic variants in genes that encode type I collagen production.
Notably, there are no EMA or FDA-approved treatments for OI, though supportive care like bracing, physical therapy, and surgery are standard, except for neridronate, which is approved in Italy.
Last December 2025, Mereo announced results from its Phase 3 ORBIT and COSMIC studies of setrusumab (UX143) in Osteogenesis Imperfecta in which neither study met the primary endpoint of reducing annualised clinical fracture rate compared with placebo or bisphosphonates, respectively. But both studies achieved their secondary endpoints of improvements in bone mineral density (BMD) against comparators, placebo and bisphosphonates, with statistical significance.
Data from the Phase 3 Orbit and Cosmic studies of setrusumab in osteogenesis imperfecta, including data on bone mineral density, vertebral fractures, and patient-reported outcomes on pain and physical function, will be presented at the J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 1:30 pm.
The reductions and delays in pre-commercial and manufacturing activities related to setrusumab following the recent top-line data from the Phase 3 Orbit and Cosmic studies have extended the firm's cash runway to mid-2027, said Denise Scots-Knight, Chief Executive Officer of Mereo.
He added that they continue to assess the overall Phase 3 trial data to determine next steps, including potential interactions with regulators.
-Alvelestat (MPH-966) For Alpha-1 antitrypsin deficiency and Bronchiolitis Obliterans Syndrome
Alvelestat is Mereo's yet another rare disease product candidate, which is an oral drug being investigated for the treatment of severe Alpha-1 antitrypsin deficiency (AATD) and Bronchiolitis Obliterans Syndrome (BOS). Alpha-1 Antitrypsin Deficiency (AATD) is a rare, genetic condition that results in a deficiency of alpha-1 antitrypsin. This protein protects the lungs against damage caused by neutrophil elastase, a key enzyme that the body releases during inflammation.
Alvelestat may have the potential to offer the convenience of an oral regimen and the potential benefit of daily dosing for sustained control of neutrophil elastase.
The company is continuing to advance key activities to support the planned initiation of the global Phase 3 pivotal study.
Mereo expects that a single Phase 3 trial enrolling approximately 220 early- and late-stage AATD-LD patients, evaluating alvelestat over an 18-month treatment period, will support regulatory submissions in both the U.S. and Europe.
The primary efficacy endpoint for U.S. approval will be the St. George's Respiratory Questionnaire (SGRQ) Total Score, with lung density measured by CT scan serving as the primary endpoint for potential European regulatory approval.
Mereo continues to be in active discussions with potential partners for the Phase 3 development and commercialisation of alvelestat.
Vantictumab (OMP18R5) for autosomal dominant osteopetrosis Type 2
Vantictumab is Mereo's out-licensed product to Ashibio, Inc. for autosomal dominant osteopetrosis Type 2 (ADO2) while etaining European rights.
Ashibio will fully fund the global program, with a phase 2 study of vantictumab in Autosomal Dominant Osteopetrosis Type 2 (ADO2), a rare bone disease, planned for the second half of 2026. Over the past year, MREO traded between $0.20 and $3.25. The stock closed Tuesday's trade at $0.66, up 16.34%.
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