Mereo BioPharma Group plc Initiation of BPS-804 Phase 2b study (1223E)
May 04 2017 - 2:00AM
UK Regulatory
TIDMMPH
RNS Number : 1223E
Mereo BioPharma Group plc
04 May 2017
Mereo BioPharma Group plc
("Mereo" or the "Company" or the "Group")
Initiation of BPS-804 potentially pivotal Phase 2b study in
patients with osteogenesis imperfecta, an orphan disease
Headline data expected mid-2018
London, 4 May 2017 - Mereo BioPharma Group plc (AIM: MPH), a
clinical stage, UK-based, biopharmaceutical company focused on rare
and specialty diseases, announced today the initiation of the
potentially pivotal Phase 2b clinical study of BPS-804 for the
treatment of the orphan disease, osteogenesis imperfecta (OI)
(brittle bone disease), the ASTEROID study. BPS-804 has been
granted Orphan Drug Designation by the US FDA and the EMA. BPS-804
has also been accepted into the EMA's Adaptive Pathways
Programme.
Dr Denise Scots-Knight, Chief Executive Officer of Mereo
BioPharma Group plc commented:
"The initiation of this potentially pivotal trial is an
important milestone in the development of BPS-804. Osteogenesis
imperfecta is a serious, debilitating and painful disease for which
there are currently no approved treatments that address the
underlying bone weakness. We believe BPS-804's mechanism of action
is specifically suited to OI and has the potential to become a
novel treatment option that could reduce fractures and improve
quality of life of these patients. We look forward to announcing
the top-line results for the ASTEROID study, which we expect in
mid-2018."
OI is a rare genetic disorder that is characterized by fragile
bones that break easily. Current treatment of OI patients is
largely surgical and focuses on reducing pain or addressing the
complications associated with this disorder. BPS-804 is a fully
humanised monoclonal antibody targeting sclerostin, a protein which
itself prevents the activity of bone-forming cells. Treatment with
BPS-804 increases bone formation and reduces bone resorption,
thereby strengthening the bone and potentially reducing fractures
in OI patients.
Clinical studies in 83 patients to date have shown that BPS-804
is safe and well tolerated. In a study in OI patients BPS-804
showed a statistically significant improvement in bone mineral
density and on bone biomarkers.
Details of the study
The Phase 2b trial is expected to enrol up to 120 adult OI
patients and is a randomised, double-blind, placebo-controlled,
multi-centre study which is being conducted in the US and
Europe.
The study's primary endpoint is change in trabecular volumetric
bone mineral density measured by high resolution peripheral
quantitative CT (HRpQCT) and change in bone strength on finite
element analysis (FEA). Additional endpoints include further
measures of bone parameters on HRpQCT, bone turnover markers and
quality of life scores.
Mereo intends to begin a further study in paediatric OI patients
in H2 2017.
For further information on patient recruitment of this trial,
visit: https://clinicaltrials.gov/ NCT identifier: NCT03118570
For Further Enquiries:
Mereo BioPharma Group
plc +44 (0)333 023 7319
Denise Scots-Knight, Chief
Executive Officer
Richard Jones, Chief Financial
Officer
Nominated Adviser and
Joint Broker
Cantor Fitzgerald Europe +44 (0)20 7894 7000
Phil Davies
Will Goode
Joint Broker
RBC Capital Markets +44 (0)20 7653 4000
Rupert Walford
Laura White
Public Relations Adviser
to Mereo Biopharma
FTI Consulting +44 (0)20 3727 1000
Ben Atwell
Simon Conway
Brett Pollard
About Mereo
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 2b study with BGS-649
and a Phase 2 study with acumapimod.
Mereo initiated the first pivotal Phase 2b trial for BPS-804
(the ASTEROID study) 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.
This information is provided by RNS
The company news service from the London Stock Exchange
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