TIDMMPH
RNS Number : 0176A
Mereo BioPharma Group plc
24 September 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 Receives FDA Rare Pediatric Disease Designation
for Setrusumab for the Treatment of Osteogenesis Imperfecta
London and Redwood City, Calif., September 24, 2020 - Mereo
BioPharma Group plc (NASDAQ: MREO, AIM: MPH), "Mereo" or "the
Company", a clinical-stage biopharmaceutical company focused on
oncology and rare diseases, today announces that the U.S. Food and
Drug Administration ("FDA") has granted Rare Pediatric Disease
designation to setrusumab for the treatment of osteogenesis
imperfecta ("OI"). Setrusumab is a fully humanized monoclonal
antibody that inhibits sclerostin, a protein which inhibits the
activity of bone-forming cells. OI is a genetic rare disorder with
no approved treatments that is characterized by reduced bone mass
and fragile bones that break easily. In Mereo's 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 in adults with OI.
The FDA grants Rare Pediatric Disease Designation for serious
and life-threatening diseases that primarily affect children aged
18 years or younger and fewer than 200,000 people in the United
States. If a Biologics License Application ("BLA") in the United
States for setrusumab is approved, Mereo may be eligible to receive
a priority review voucher from the FDA, which can be redeemed to
obtain priority review for any subsequent marketing application and
may be sold or transferred to other companies for their programs,
as has been done by other voucher recipients.
"Receiving Rare Pediatric Disease designation from the FDA
highlights the significant unmet medical need facing children with
OI and underscores the potential of setrusumab to become the first
approved treatment option specifically for these patients," said
Dr. Denise Scots-Knight, Chief Executive Officer of Mereo.
"Following the completion of our Phase 2b ASTEROID study, we are
pleased that both the FDA and EMA have agreed on the principles of
a design of a single Phase 3 pivotal pediatric study in OI. We
believe there is a clear path forward for setrusumab in OI and are
continuing discussions with potential partners prior to the
initiation of a Phase 3 study consistent with our Company
strategy."
About Osteogenesis Imperfecta
Osteogenesis Imperfecta (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. Setrusumab
was accepted into the EMA's Adaptive Pathways program in the EU and
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. Following the review of the data from the Phase 2b ASTEROID
study, the FDA agreed on the principles of a design of a Phase 3
pediatric study in OI to be completed prior to the submission of a
BLA in the United States, which is also in line with Mereo's
proposed pivotal pediatric study design that has been agreed to in
principle with the European Medicines Agency ("EMA"). Mereo intends
to partner setrusumab prior to conducting a pivotal trial of
setrusumab in children with severe OI.
About Mereo BioPharma
Mereo BioPharma is a biopharmaceutical company focused on the
development and commercialization of innovative therapeutics that
aim to improve outcomes for oncology and rare diseases. Mereo's
lead oncology product candidate, etigilimab (Anti-TIGIT), has
completed a Phase 1a dose escalation clinical trial in patients
with advanced solid tumors and has been evaluated in a Phase 1b
study in combination with nivolumab in select tumor types. Mereo's
rare disease product portfolio consists of setrusumab, which has
completed a Phase 2b dose-ranging study in adults with OI, as well
as alvelestat, which is being investigated in a Phase 2
proof-of-concept clinical trial in patients with alpha-1
antitrypsin deficiency (AATD) and in a Phase 1b/2 clinical trial in
COVID-19 respiratory disease.
Additional Information
The person responsible for arranging the release of this
information on behalf of the Company is Charles Sermon, General
Counsel.
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 and Section 21E of the United States Securities Exchange
Act of 1934, as amended. Forward-looking statements usually relate
to future events and 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. 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. You should not 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 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
N+1 Singer (Nominated Adviser and Broker to Mereo ) +44 (0)20 7496 3081
Phil Davies
Will Goode
Burns McClellan (US Investor Relations Adviser to Mereo ) + 01 212 213 0006
Lisa Burns
Steve Klass
FTI Consulting (UK Public Relations Adviser to Mereo ) +44 (0)20 3727 1000
Simon Conway
Ciara Martin
Investors investors@ mereo biopharma.com
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