TIDMMPH
RNS Number : 1110X
Mereo BioPharma Group plc
25 August 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 Initiation of Placebo-Controlled Phase
1b/2 Clinical Trial with Alvelestat in COVID-19 Respiratory
Disease
London and Redwood City, Calif., August 25, 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 announced the initiation of a
Phase 1b/2 placebo-controlled clinical trial to evaluate the safety
and efficacy of alvelestat in hospitalized, adult patients with
moderate to severe COVID-19 respiratory disease. Alvelestat is a
novel, oral small molecule designed to inhibit neutrophil elastase
(NE), a key enzyme involved in the destruction of lung tissue.
Alvelestat is already being investigated by Mereo in a Phase 2
proof-of-concept clinical trial in patients with alpha-1
antitrypsin deficiency ("AATD").
Acute Lung Injury (ALI) is a manifestation of systemic
inflammation in the lungs that can result from SARS-CoV-2
infection. Neutrophil extracellular traps (NETs), involving the
enzyme neutrophil elastase (NE), may contribute to the pathogenesis
of ALI via cytokine and neutrophil activation. NET formation
(NETosis) also plays an important role in arterial and venous
thrombosis, which have been shown to be common complications of
COVID-19. By inhibiting NE, alvelestat demonstrated efficacy in
preclinical models of treating ALI driven by NETosis([1]) .
"As we learn more about COVID-19 from data now accumulated from
patients worldwide, there is a rationale for blocking NE and
therefore the use of alvelestat as a potential treatment for
patients hospitalized with acute lung injury associated with
COVID-19," said Dr. J. Michael Wells, Assistant Professor in
Medicine at the University of Alabama at Birmingham. "NE is the key
enzyme involved in NET formation, degrading intracellular proteins
and triggering the release of fibres studded with inflammatory and
tissue damaging enzymes. Inhibiting NE with alvelestat could target
the disease to prevent NETs and also once NETosis is underway. By
way of this unique mechanism of action, I believe alvelestat may
have the potential to help address the needs of patients with
moderate to severe COVID-19 respiratory disease."
The Phase 1b/2 trial is a randomized, double-blind,
placebo-controlled study to assess the safety and efficacy of
alvelestat in adult patients hospitalized with moderate to severe
COVID-19 respiratory disease not yet receiving mechanical
ventilation. The trial is led by Dr. J. Michael Wells and will be
conducted at the University of Alabama. Approximately 15 patients
will be randomized (2:1) to receive either alvelestat plus standard
of care or placebo plus standard of care for 10 days. The primary
endpoint of the trial is safety and tolerability of alvelestat at
day 10, with a safety follow up to day 90. Additional endpoints
include blood biomarkers (NETosis, inflammation and
hypercoagulation) and oxygen deficit (as measured by the ratio of
oxygen saturation to the fraction of inspired oxygen, SaO2/FiO2) at
day 10. The trial will also assess clinical outcomes, including
effect on disease progression measured by need for respiratory
support and disease severity using the WHO 9-point ordinal scale at
day 29.
"We believe alvelestat may have the potential to become an
important therapeutic option for COVID-19-associated respiratory
disease," said Dr. Jackie Parkin, Head of the Alvelestat Program at
Mereo. "We look forward to working closely with our colleagues at
the University of Alabama to investigate alvelestat in this patient
population and to complete this study as rapidly as possible to
help with the ongoing effort to solve the global COVID-19
crisis."
About Alvelestat
Alvelestat (MPH-966) is a novel, oral small molecule designed to
inhibit neutrophil elastase (NE), a neutrophil protease, which is a
key enzyme involved in the destruction of lung tissue. Mereo is
conducting a Phase 2 proof-of-concept clinical trial with
alvelestat for the treatment of severe alpha-1 antitrypsin
deficiency ("AATD"), a potentially life-threatening, rare, genetic
condition caused by a lack of effective alpha-1 antitrypsin
("AAT"), a protein that protects the lungs from enzymatic
degradation. This degradation leads to severe debilitating
diseases, including early-onset pulmonary emphysema, a disease that
irreversibly destroys the tissues that support lung function. By
inhibiting NE, Mereo believes alvelestat has the potential to
protect AATD patients from further lung damage.
Investigator-sponsored studies with alvelestat are also underway in
AATD and in bronchiolitis obliterans syndrome (BOS).
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 osteogenesis
imperfecta ("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").
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 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 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.
({1]) Li, Haitao et al. "Neutrophil extracellular traps
contribute to the pathogenesis of acid-aspiration-induced
ALI/ARDS." Oncotarget vol. 9,2 1772-1784. 28 Nov. 2017,
doi:10.18632/oncotarget.22744
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
Aubrey Powell
Burns McClellan (US Investor Relations Adviser
to Mereo) +1 212 213 0006
Lisa Burns
Steve Klass
FTI Consulting (UK Public Relations Adviser
to Mereo ) +44 (0)20 3727 1000
Simon Conway
Ciara Martin
Investors investors@mereobiopharma.com
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