London, 20 February 2017 – Mereo BioPharma Group plc (AIM: MPH), a clinical stage, UK-based, biopharmaceutical company focused on rare and specialty diseases, is pleased to announce that BPS-804 has been accepted to participate in the European Medicines Agency’s (EMA) Adaptive Pathways programme.
BPS-804 is being developed for the treatment of osteogenesis imperfecta (OI) (brittle bone disease). It has been granted orphan drug designation by both the European Commission (EC) and the U.S. Food and Drug Administration (FDA).
OI is a rare genetic disorder that is characterized by fragile bones that break easily, for which there are currently no EMA or FDA approved treatments. BPS-804 works by inhibiting sclerostin, which itself inhibits the activity of bone-forming cells, known as osteoblasts. The Company believes that by blocking sclerostin, BPS-804 will induce or increase osteoblast function and maturation, increasing bone formation and reducing bone resorption, thereby reducing bone fragility and fractures in OI patients.
“We are delighted that BPS-804 has been accepted on to the EMA’s Adaptive Pathways programme.Osteogenesis imperfecta is a serious, debilitating and painful disease where we believe BPS-804 could reduce fractures and improve quality of life in OI patients. We are on track to initiate a phase 2b trial for BPS-804 in H1 2017 and as part of the Adaptive Pathways we have the potential to bring this important therapy to patients sooner.”Dr Denise Scots-Knight Chief Executive Officer of Mereo BioPharma Group plc
For Further Enquiries:
|Mereo BioPharma Group plc
Denise Scots-Knight, Chief Executive Officer
|+44 (0)333 023 7319|
Nominated Adviser and Joint Broker
|+44 (0)20 7894 7000|
|+44 (0)20 7653 4000|
Public Relations Adviser to Mereo Biopharma
|+44 (0)20 3727 1000|
Mereo is a UK-based biopharmaceutical company focused on the development of innovative medicines that aim to address unmet medical needs in rare and specialty disease areas and improve patient quality of life. The Company seeks to selectively acquire development-stage product candidates with demonstrated clinically meaningful data from large pharmaceutical companies and to rapidly progress these product candidates to subsequent value inflection points.
Mereo combines the operational discipline and efficiency of a small company with the financial resources to conduct comprehensive clinical studies. The Company has the option to directly commercialise products, for example in orphan diseases, in addition to partnering or divesting its products.
Mereo’s initial portfolio consists of three mid-late stage clinical assets that were acquired from Novartis in July 2015. BPS-804 is being developed for the prevention of fractures resulting from osteogenesis imperfecta (brittle bone disease); acumapimod (BCT-197), is being developed to treat inflammation in patients with an AECOPD; and BGS-649 is a once-weekly pill to restore normal testosterone levels in men with hypogonadotropic hypogonadism.
In H1 2016 the Company initiated a Phase 2 study with acumapimod and a Phase 2b study with BGS-649. Mereo expects to commence the first pivotal trial for BPS-804 during H1 2017. Additional product opportunities, from a range of large pharmaceutical and biotechnology companies, are under active evaluation.
About osteogenesis imperfecta (OI)
OI is a rare genetic disorder that is characterized by fragile bones that break easily. In addition to fractures, people with OI often have muscle weakness, hearing loss, fatigue, joint laxity, curved bones, scoliosis, and short stature. The majority of cases of OI (estimated at approximately 90 %) 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 the Adaptive Pathway
The Adaptive Pathways approach is part of the European Medicines Agency’s (EMA) efforts to improve timely access for patients to new medicines, primarily in areas of high medical need. Adaptive Pathways is a scientific concept for medicine development and data generation which allows for early and progressive patient access to a medicine. The approach makes use of the existing European Union (EU) regulatory framework for medicines and is based on three principles:
1) Iterative development, which either means:
- approval in stages, beginning with a restricted patient population then expanding to wider
- confirming the benefit-risk balance of a product, following a conditional approval based on
early data (using surrogate endpoints) considered predictive of important clinical
2) Gathering evidence through real-life use to supplement clinical trial data;
3) Early involvement of patients and health-technology-assessment bodies in discussions on a
For more information, visit: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000601.jsp