Mereo BioPharma Group plc Completion of Patient Enrolment in Phase 2b study (9604D)
October 15 2018 - 1:00AM
UK Regulatory
TIDMMPH
RNS Number : 9604D
Mereo BioPharma Group plc
15 October 2018
Mereo BioPharma Group plc
("Mereo" or the "Company" or the "Group")
Completion of Patient Enrolment in Phase 2b study
of BPS-804 for the treatment of Osteogenesis Imperfecta
Six month efficacy data from top dose open label cohort expected
H1 2019
Top-line results expected H2 2019
London, 15 October 2018 - Mereo BioPharma Group plc (AIM: MPH),
a clinical stage UK based biopharmaceutical company focused on rare
diseases, today announced it has successfully completed patient
enrolment in the potentially pivotal adult phase 2b ASTEROID
clinical study of BPS-804 (Setrusumab) for the treatment of
osteogenesis imperfecta (OI), an orphan genetic disorder known as
brittle bone disease.
A total of 112 adult patients have been enrolled into this
multi-centre, randomised, double-blind, dose-finding study, which
is being conducted in the US and Europe. The study has 4 arms and
includes an open-label arm which is expected to report six-month
data on the top dose in H1 2019 and 12-month data in H2 2019.
Top-line 12 month data from the blinded dose ranging part of the
study is expected in Q4 2019. 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 and granted
PRIority MEdicines (PRIME) designation.
The study's primary endpoint is change from baseline of Bone
Mineral Density (BMD) after 12 months as measured by High
Resolution peripheral Quantitative Computed Tomography (HR-pQCT)
and the secondary endpoints of BMD using traditional
two-dimensional dual-energy X-ray absorptiometry (DXA) measurement
together with measurement of serum bone biomarkers. Bone
microarchitecture assessed by HRpQCT has been shown to be a
predictor of fracture risk in postmenopausal women (The OFLEY
study(1) ). In a previous study in OI patients, BPS-804 showed a
statistically significant improvement in BMD and on bone
biomarkers.
In August 2018, the Company's Paediatric Investigation Plan
(PIP) was approved by the European Medicine Agency. Mereo plans to
commence this registration trial in approximately 160 children with
severe disease aged 5-18 years old in 2019. The primary endpoint
will be fracture rate over a 12-month period.
Alastair Mackinnon, Chief Medical Officer of Mereo BioPharma
Group plc commented:
"This is another important milestone in the development of
BPS-804 for Osteogenesis Imperfecta, which is a serious,
debilitating and painful orphan disease for which there are
currently no EMA or FDA approved treatments. 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 data from this study during the course of
2019."
About BPS-804 (Setrusumab)
BPS-804 is a fully humanised monoclonal antibody that inhibits
sclerostin, a protein which inhibits the activity of bone-forming
cells. The mechanism of action of BPS-804 could be particularly
well suited for the treatment of OI and has the potential to become
a novel treatment that could reduce fractures and improve patient
quality of life.
About OI
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.
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.
1 Bone microarchitecture assessed by HRpQCT as Predictor of
Fracture Risk in Postmenopausal Women: The OFELY Study Journal of
Bone Mineral Research 9 March 2017
About Mereo BioPharma
Mereo is a biopharmaceutical company focused on the development
and commercialization of innovative therapeutics that aim to
improve outcomes for patients with rare diseases. The portfolio
currently consists of four clinical-stage product candidates, each
of which were acquired from large pharmaceutical companies: BPS-804
(setrusumab) for the treatment of osteogenesis imperfecta ("OI");
MPH-966 (alvelestat) for the treatment of severe alpha-1
antitrypsin deficiency ("AATD"); BCT-197 for the treatment of acute
exacerbations of chronic obstructive pulmonary disease, ("AECOPD");
and BGS-649 for the treatment of hypogonadotropic hypogonadism
("HH") in obese men. Each of the Company's product candidates has
generated positive clinical data for Mereo's target indication or
in a related indication. The Company's strategy is to selectively
acquire product candidates that have already received significant
investment from pharmaceutical companies and that have substantial
preclinical, clinical and manufacturing data packages. Since
inception the Company has commenced large, randomized,
placebo-controlled Phase 2 clinical trials for all four of the
product candidates and has previously announced positive top-line
results from two of its clinical trials: a Phase 2 trial with
BCT-197 in December 2017 and a Phase 2b dose-ranging study with
BGS-649 in March 2018.
For Further Enquiries:
Mereo BioPharma Group plc +44 (0)333 023 7300
Denise Scots-Knight, Chief Executive
Officer
Richard Jones, Chief Financial Officer
Cantor Fitzgerald Europe (Nominated
Adviser and Broker) +44 (0)20 7894 7000
Phil Davies
Will Goode
Rick Thompson
RBC Capital Markets (Joint Broker) +44 (0)20 7653 4000
Rupert Walford
Jamil Miah
FTI Consulting (Public Relations Adviser) +44 (0)20 3727 1000
Simon Conway
Brett Pollard
Burns McClellan (US Public Relations
Advisor to Mereo Biopharma) +01 (0) 212 213 0006
Lisa Burns
Steven Klass
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END
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