Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world’s
leading producers of plasma-derived medicines, today announced it
has completed enrollment in PRECIOSA (NCT03451292), its phase 3
clinical trial designed to determine the potential of long-term
albumin treatment with Grifols Albutein® to increase survival time
in patients with decompensated cirrhosis and ascites until a
suitable transplant is available.
Cirrhosis, a condition in which the liver is permanently scarred
and can lead to liver failure, is the leading cause of
liver-related deaths globally,1 with more than 1.32 million deaths
reported in 2017.2 In the U.S. alone, researchers estimate that
about 1 in 400 adults have cirrhosis,3 including those who have
progressed into decompensated cirrhosis once complications such as
ascites appear. Ascites is a buildup of fluid in the abdomen and
signals that a patient’s risk for poor outcomes, including death,
have significantly increased.
Albumin, the most abundant protein in plasma, has antioxidant
and anti-inflammatory properties with the potential to mitigate the
complications associated with decompensated cirrhosis and its
progression into the next stage of the disease, acute-on-chronic
liver failure (ACLF). Treatment with albumin has the potential to
reduce the high one-year mortality rates observed in decompensated
cirrhosis.
Over 400 patients with decompensated cirrhosis with ascites are
participating in this multi-center, randomized (1:1), controlled,
parallel-group, open-label study in 69 sites across North America
and Europe. It will evaluate the efficacy and safety of long-term
Albutein® administration (dosed every 10 ± 2 days for up to 12
months) plus standard medical treatment.
“There is great potential for albumin to improve the survival
prospects of patients suffering from decompensated cirrhosis until
they can get a liver transplant, a large unmet need given the
limited availability of livers for patients,” said Sandra Camprubi,
Grifols Senior Director Clinical Operations. “We look forward to
providing topline data from this study in the fourth quarter of
2024 and evaluating next regulatory steps to provide patients with
a much-needed treatment.”
Grifols is committed to strengthening its innovation pipeline,
which consists of multiple plasma and non-plasma programs across
various clinical stages, all dedicated to potential treatments to
help patients live longer, better-quality lives.
About Decompensated Cirrhosis and Ascites
Chronic liver disease is an all too common and growing problem
in the developed world, with worldwide prevalence rates of around
20%.4 One such condition is cirrhosis, in which the liver is
permanently scarred and, in many cases, can lead to liver failure.
Decompensated cirrhosis is defined by the complications that can
occur in a patient with cirrhosis, which include ascites, variceal
bleeding, hepatic encephalopathy, and bacterial infections. These
complications are associated with worse survival (2-4 years)
compared with compensated cirrhosis (10-15 years).5
About Grifols
Grifols is a global healthcare company founded in Barcelona in
1909 committed to improving the health and well-being of people
around the world. A leader in essential plasma-derived medicines
and transfusion medicine, the company develops, produces and
provides innovative healthcare services and solutions in more than
110 countries.
Patient needs and Grifols’ ever-growing knowledge of many
chronic, rare and prevalent conditions, at times life-threatening,
drive the company’s innovation in both plasma and other
biopharmaceuticals to enhance quality of life. Grifols is focused
on treating conditions across a broad range of therapeutic areas:
immunology, hepatology and intensive care, pulmonology, hematology,
neurology and infectious diseases.
A pioneer in the plasma industry, Grifols continues to grow its
network of donation centers, the world’s largest with over 390
across North America, Europe, Africa and the Middle East and
China.
As a recognized leader in transfusion medicine, Grifols offers a
comprehensive portfolio of solutions designed to enhance safety
from donation to transfusion, in addition to clinical diagnostic
technologies. It provides high-quality biological supplies for
life-science research, clinical trials, and for manufacturing
pharmaceutical and diagnostic products. The company also supplies
tools, information and services that enable hospitals, pharmacies
and healthcare professionals to efficiently deliver expert medical
care.
Grifols, with more than 24,000 employees in more
than 30 countries and regions, is committed to a sustainable
business model that sets the standard for continuous innovation,
quality, safety and ethical leadership.
In 2022, Grifols’ economic impact in its core countries of
operation was EUR 9.6 billion. The company also generated 193,000
jobs, including indirect and induced.
The company’s class A shares are listed on the Spanish Stock
Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols
non-voting class B shares are listed on the Mercado Continuo
(MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS).
For more information, please visit
www.grifols.com.
MEDIA CONTACT:
Media Press Officemedia@grifols.comTel. +34 93
571 00 02
INVESTORS: Investors Relations
Department &
Sustainabilityinversores@grifols.com -
investors@grifols.comTel. +34 93 571 02 21
LEGAL DISCLAIMER
The facts and figures contained in this report
that do not refer to historical data are “future projections and
assumptions”. Words and expressions such as “believe”, “hope”,
“anticipate”, “predict”, “expect”, “intend”, “should”, “will seek
to achieve”, “it is estimated”, “future” and similar expressions,
insofar as they relate to the Grifols group, are used to identify
future projections and assumptions. These expressions reflect the
assumptions, hypotheses, expectations and predictions of the
management team at the time of writing this report, and these are
subject to a number of factors that mean that the actual results
may be materially different. The future results of the Grifols
group could be affected by events relating to its own activities,
such as a shortage of supplies of raw materials for the manufacture
of its products, the appearance of competitor products on the
market, or changes to the regulatory framework of the markets in
which it operates, among others. At the date of compiling this
report, the Grifols group has adopted the necessary measures to
mitigate the potential impact of these events. Grifols, S.A. does
not accept any obligation to publicly report, revise or update
future projections or assumptions to adapt them to events or
circumstances subsequent to the date of writing this report, except
where expressly required by the applicable legislation. This
document does not constitute an offer or invitation to buy or
subscribe shares in accordance with the provisions of the following
Spanish legislation: Royal Legislative Decree 4/2015, of 23
October, approving recast text of Securities Market Law; Royal
Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4
November, and any regulations developing this legislation. In
addition, this document does not constitute an offer of purchase,
sale or exchange, or a request for an offer of purchase, sale or
exchange of securities, or a request for any vote or approval in
any other jurisdiction. The information included in this document
has not been verified nor reviewed by the external auditors of the
Grifols group.
1 GBD 2017 Causes of Death Collaborators. Global, regional, and
national age-sex-specific mortality for 282 causes of death in 195
countries and territories, 1980-2017: a systematic analysis for the
Global Burden of Disease Study 2017. Lancet.
2018;392(10159):1736-1788. doi:10.1016/S0140-6736(18)32203-72 GBD
2017 Cirrhosis Collaborators. The global, regional, and national
burden of cirrhosis by cause in 195 countries and territories,
1990-2017: a systematic analysis for the Global Burden of Disease
Study 2017. Lancet Gastroenterol Hepatol. 2020;5(3):245-266.
doi:10.1016/S2468-1253(19)30349-83 Scaglione S, Kliethermes S, Cao
G, et al. The Epidemiology of Cirrhosis in the United States: A
Population-based Study. J Clin Gastroenterol. 2015;49(8):690-696.
doi:10.1097/MCG.00000000000002084 Moon AM, Singal AG, Tapper EB.
Contemporary epidemiology of chronic liver disease and
cirrhosis. Clin Gastroenterol Hepatol. 2020;18(12):2650-2666.
doi: 10.1016/j.cgh.2019.07.0605 López-Sánchez GN, Dóminguez-Pérez
M, Uribe M, Nuño-Lámbarri N. The fibrogenic process and the
unleashing of acute-on-chronic liver failure. Clin Mol Hepatol.
2020;26(1):7-15. doi:10.3350/cmh.2019.0011; Fanali G, di Masi A,
Trezza V, Marino M, Fasano M, Ascenzi P. Human serum albumin: from
bench to bedside. Mol Aspects Med. 2012;33(3):209-290.
doi:10.1016/j.mam.2011.12.002
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