Mereo BioPharma Group plc BPS-804 receives PRIME designation (2476W)
13 November 2017 - 6:00PM
UK Regulatory
TIDMMPH
RNS Number : 2476W
Mereo BioPharma Group plc
13 November 2017
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Mereo BioPharma Group plc
("Mereo" or the "Company")
Mereo receives EMA PRIME designation for BPS-804 to treat
osteogenesis imperfecta
BPS-804 to receive EMA ongoing advice with the potential for
accelerated regulatory assessment in Europe
London, 13 November 2017 - Mereo BioPharma Group plc (AIM: MPH),
a multi-asset, clinical stage, biopharmaceutical company focused on
rare and specialty diseases, today announces that the European
Medicines Agency (EMA) has granted BPS-804 PRIority MEdicines
(PRIME) designation for the treatment of osteogenesis imperfecta
(OI), or "brittle bone disease." OI is a debilitating disease for
which there is no current treatment approved by the U.S. Food and
Drug Administration (FDA) or the EMA. Mereo announced commencement
of a Phase 2b trial for BPS-804 in adult patients with OI in May
2017.
The EMA PRIME programme provides early collaborative input to
clinical development including scientific advice and
health-technology-assessment in order to facilitate rapid access
for patients to novel drugs in areas of high unmet medical need
once they are approved. Since its inception in 2016, only 31 of 137
requests for PRIME have been granted. Under the PRIME programme, a
marketing authorisation application (MAA) in Europe for BPS-804 for
OI could be eligible for an accelerated regulatory assessment (150
days instead of 210 days).
As previously announced, BPS-804 for OI has also been accepted
into the EMA's Adaptive Pathways Programme and has been granted
orphan drug status in both the US and EU.
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.
Dr Denise Scots-Knight, Chief Executive Officer of Mereo
BioPharma Group plc commented:
"We are delighted that the EMA has awarded BPS-804 a PRIME
designation for OI. We believe this is further recognition that OI
is a disease with a high unmet medical need and that BPS-804 has
the potential to provide a much needed novel treatment option for
these patients. We look forward to collaborating closely with the
EMA through both PRIME and the Adaptive Pathways Programme to
expedite the development of BPS-804 and potentially accelerate
availability of this therapy for patients."
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.
About PRIME
The PRIME initiative is a programme launched by the EMA to
enhance support for the development of treatments in diseases of
high unmet medical need which may offer a significant therapeutic
benefit over existing treatment options or address a disease where
there are currently no treatment options. PRIME is designed to
accelerate availability of these new treatment options to
patients.
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
FTI Consulting +44 (0)20 3727 1000
Ben Atwell
Simon Conway
Brett Pollard
US Public Relations Advisor
to Mereo +01 (0) 212 213
Burns McClellan 0006
Lisa Burns
Steven Klass
About Mereo
Mereo is a multi-asset biopharmaceutical company focused on the
acquisition, development and commercialization of innovative
therapeutics that improve outcomes for patients with rare and
speciality diseases. Mereo's current portfolio consists of four
clinical--stage product candidates, all of which were acquired or
licensed from large pharmaceutical companies: BPS-804 for the
treatment of OI; AZD-9668 (alvelestat) for the treatment of alpha-1
antitrypsin deficiency (AATD), BGS-649 for the treatment of
hypogonadotropic hypogonadism (HH) in obese men and BCT-197
(acumapimod) for the treatment of acute exacerbations of chronic
obstructive pulmonary disease (AECOPD). Each of these product
candidates has demonstrated either positive preclinical and
clinical data for the Company's target indications or data in
related indications. Mereo has commenced large, randomised, placebo
controlled Phase 2 clinical trials for three of its product
candidates, two of which are fully enrolled (BGS-649 and BCT-197).
The Company intends to commence additional late-stage clinical
trials in 2018.
This information is provided by RNS
The company news service from the London Stock Exchange
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