TIDMMPH
RNS Number : 5124E
Mereo BioPharma Group plc
28 February 2020
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS DEFINED UNDER
THE MARKET ABUSE REGULATION (EU) NO. 596/2014. UPON PUBLICATION OF
THIS ANNOUNCEMENT THIS INFORMATION IS NOW CONSIDERED IN THE PUBLIC
DOMAIN.
Mereo BioPharma Announces Positive Feedback from Type B
End-of-Phase 2 Meeting with the FDA and Outlines Pivotal Phase 3
Pediatric Study Design for Setrusumab in Osteogenesis
Imperfecta
London and Redwood City, Calif., February 28, 2020 - Mereo
BioPharma Group plc (NASDAQ: MREO, AIM: MPH), "Mereo" or the
"Company," a clinical stage biopharmaceutical company focused on
rare diseases, today announced the successful completion of a Type
B End-of-Phase 2 meeting with the U.S. Food and Drug Administration
("FDA") to discuss the development of setrusumab, an
anti-sclerostin antibody, for the treatment of children and
adolescents with osteogenesis imperfecta ("OI"). OI is a genetic
rare disorder characterized by reduced bone mass and fragile bones
that break easily. There are currently no approved treatments for
OI.
Following the review of the data from the Company's Phase 2b
ASTEROID study with setrusumab in adults with OI, the FDA agreed on
the design of a Phase 3 pediatric study in OI to be completed prior
to the submission of a Biologics License Application ("BLA") in the
United States. This is in line with Mereo's proposed pivotal
pediatric study design that has already been agreed to in principle
with the European Medicines Agency ("EMA"). The Phase 3 pediatric
study will include the following elements:
-- A single study with two cohorts in approximately 160 children
and adolescents ages 2 to <18 years diagnosed with Type I, III
or IV OI and a confirmed genetic mutation leading to a collagen
defect;
-- A safety cohort with a limited number of patients will
confirm the dose of setrusumab based on safety and the efficacy
cohort will be a two-arm, randomized, double-blind, active control
design of 12 months duration;
-- In the efficacy cohort, participants will be randomized to
one of two double-blinded study arms: in one arm participants will
receive setrusumab at a dose equivalent to the high-dose arm
utilized in the Phase 2b ASTEROID study and in the other arm,
participants will receive a standardized bisphosphonate;
-- Primary endpoint of fracture rate versus active control following 12 months of treatment; and
-- Secondary endpoints of bone mineral density (BMD) at the
lumbar spine at 12 months over baseline measured using
two-dimensional dual-energy X-ray absorptiometry (DXA), bone
biomarkers, patient reported outcomes (PRO) and quality of life
measures.
"We are pleased with the productive feedback we received from
the FDA during our End-of-Phase 2 meeting," said Dr. Denise
Scots-Knight, Chief Executive Officer of Mereo. "Overall, the final
pivotal study design will be consistent with what we had previously
agreed to in principle with the EMA. We now have a clear path
forward to initiate a Phase 3 study of setrusumab in pediatric OI
that incorporates feedback from both the FDA and EMA and is
intended to support the filings of a BLA in the United States and a
Marketing Authorization Application ("MAA") in the EU. This is an
important milestone for Mereo and we are excited to continue to
develop setrusumab as there are no currently approved therapies for
OI and treatment options are greatly needed. Preparations for the
Phase 3 study are underway."
About Osteogenesis Imperfecta
Osteogenesis Imperfects (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, those with OI 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, leading to significant impacts on
overall health and quality of life. 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 FDA or
EU approved treatments.
About Setrusumab
Setrusumab is a fully humanized monoclonal antibody that
inhibits sclerostin, a protein which inhibits the activity of
bone-forming cells. The mechanism of action of setrusumab could be
particularly well suited for the treatment of OI and setrusumab has
the potential to become the first approved treatment option that
could reduce fractures and improve the quality of life for
individuals with OI. Mereo has obtained orphan drug designation in
OI for setrusumab in both the United States and the EU, in February
2017 setrusumab was accepted into the EMA's Adaptive Pathways
program in the EU and, in November 2017 it was accepted into the
EMA's Priority Medicines scheme (PRIME). In the Phase 2b ASTEROID
study, setrusumab demonstrated a dose-dependent bone building
effect and a trend of reduction in fractures in addition to being
safe and well tolerated adults with OI. On January 14, 2020 Mereo
announced additional positive prespecified endpoint data from the
Phase 2b ASTEROID study.
About Mereo BioPharma
Mereo BioPharma is a biopharmaceutical company focused on the
development and commercialization of innovative therapeutics that
aim to improve outcomes for patients with rare diseases. Mereo's
strategy is to selectively acquire product candidates for rare
diseases that have already received significant investment from
pharmaceutical and large biotechnology companies and that have
substantial preclinical, clinical and manufacturing data packages.
Mereo's lead rare disease product candidate, setrusumab, has
completed a Phase 2b dose ranging study in adults with osteogenesis
imperfecta ("OI"). Mereo's second lead product candidate,
alvelestat, is being investigated in a Phase 2 proof-of-concept
clinical trial in patients with alpha-1 antitrypsin deficiency
("AATD"). Mereo's broader pipeline consists of four additional
clinical-stage product candidates; acumapimod for the treatment of
acute exacerbations of chronic obstructive pulmonary disease
("AECOPD"), leflutrozole for the treatment of hypogonadotropic
hypogonadism ("HH") in obese men, and etigilimab ("Anti-TIGIT") for
patients with advanced or metastatic solid tumors.
Additional Information
The person responsible for arranging the release of this
information on behalf of the Company is Charles Sermon, General
Counsel of Mereo.
Forward-Looking Statements
This Announcement contains "forward-looking statements." All
statements other than statements of historical fact contained in
this Announcement are forward-looking statements within the meaning
of Section 27A of the United States Securities Act of 1933, as
amended (the "Securities Act"), and Section 21E of the United
States Securities Exchange Act of 1934, as amended (the "Exchange
Act"). Forward-looking statements usually relate to future events
and anticipated revenues, earnings, cash flows or other aspects of
our operations or operating results. Forward-looking statements are
often identified by the words "believe," "expect," "anticipate,"
"plan," "intend," "foresee," "should," "would," "could," "may,"
"estimate," "outlook" and similar expressions, including the
negative thereof. The absence of these words, however, does not
mean that the statements are not forward-looking. These
forward-looking statements are based on the Company's current
expectations, beliefs and assumptions concerning future
developments and business conditions and their potential effect on
the Company. While management believes that these forward-looking
statements are reasonable as and when made, there can be no
assurance that future developments affecting the Company will be
those that it anticipates.
All of the Company's forward-looking statements involve known
and unknown risks and uncertainties (some of which are significant
or beyond its control) and assumptions that could cause actual
results to differ materially from the Company's historical
experience and its present expectations or projections. The
foregoing factors and the other risks and uncertainties that affect
the Company's business, including those described in its Annual
Report on Form 20-F, Reports on Form 6-K and other documents filed
from time to time by the Company with the United States Securities
and Exchange Commission (the "SEC") and those described in other
documents the Company may publish from time to time should be
carefully considered. The Company wishes to caution you not to
place undue reliance on any forward-looking statements, which speak
only as of the date hereof. The Company undertakes no obligation to
publicly update or revise any of our forward-looking statements
after the date they are made, whether as a result of new
information, future events or otherwise, except to the extent
required by law.
Mereo BioPharma Contacts:
Mereo +44 (0)333 023 7300
Denise Scots-Knight, Chief Executive Officer
Richard Jones, Chief Financial Officer
Cantor Fitzgerald Europe (Nominated Adviser
and Broker to Mereo ) +44 (0)20 7894 7000
Phil Davies
Will Goode
Burns McClellan (US Public Relations Adviser
to Mereo)
+01 (0) 212 213
Lisa Burns 0006
Steve Klass
FTI Consulting (UK Public Relations Adviser
to Mereo )
Simon Conway
Ciara Martin +44 (0)20 3727 1000
Investors:
investors@mereobiopharma.com
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
MSCBBGDDXBDDGGI
(END) Dow Jones Newswires
February 28, 2020 07:00 ET (12:00 GMT)
Mereo Biopharma (LSE:MPH)
過去 株価チャート
から 12 2024 まで 1 2025
Mereo Biopharma (LSE:MPH)
過去 株価チャート
から 1 2024 まで 1 2025
