Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world’s
leading producers of plasma-derived medicines, today announced that
it has completed Cohort 1 of its Phase 1/2 study (NCT04722887)
evaluating Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15%
(Alpha-1 15%), a subcutaneous (SC) alpha1 antitrypsin (AAT)
treatment being compared to Liquid Alpha1-Proteinase Inhibitor
(Human) intravenous (IV).
Alpha1-antitrypsin deficiency (also known as alpha-1) is an
underdiagnosed1 genetic disorder that occurs when a patient has low
levels of AAT, a protective protein that safeguards the lungs.
Augmentation therapy with IV AAT is the standard medical treatment
option for patients with severe AAT deficiency and emphysema. If
proven successful in clinical trials, a SC option could provide
alpha-1 patients the ability to independently administer AAT
therapy from home, allowing for greater convenience and
flexibility.
In this multi-center, single-dose and repeat-dose study over
eight weeks, Cohort 1 has been completed and demonstrated no safety
issues with Alpha-1 15% that would prevent the study from moving
forward into Cohort 2.
“A subcutaneous option would be a first for alpha-1 patients,
providing more freedom when it comes to managing their AAT
deficiency by allowing patients to administer their medication from
the comfort of their own home. We are pleased to announce this
milestone during Alpha-1 Awareness Month, contributing to raising
further visibility about this rare disease,” said Jörg Schüttrumpf,
Chief Scientific Innovation Officer, Grifols. “We look forward to
moving this study into Cohort 2. Grifols has a strong commitment to
the alpha-1 community and continues to innovate to find additional
treatment options for patients living with this disease, in
addition to more convenient alpha-1 testing alternatives such as
AlphaID™ At Home, our recently launched direct-to-consumer genetic
health risk service.”
“During Alpha-1 Awareness month, we are excited to share this
exciting news to the Alpha-1 community of a new clinical trial
advancement in Alpha-1. We are thrilled that Grifols has completed
Cohort 1 in clinical study of Alpha-1 15% and moving forward into
Cohort 2. This study evaluating first-in-human subcutaneous dosing
option for Alpha-1 patients could provide a new option that could
easily be administered from their own homes,” said Scott
Santarella, Alpha-1 Foundation President and CEO.
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.com Tel.
+34 93 571 00 02
INVESTORS: Investors Relations
Department & Sustainabilityinversores@grifols.com -
investors@grifols.com Tel. +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 American Thoracic Society; European Respiratory Society.
American Thoracic Society/European Respiratory Society statement:
standards for the diagnosis and management of individuals with
alpha-1 antitrypsin deficiency. Am J Respir Crit Care Med.
2003;168(7):818-900. doi:10.1164/rccm.168.7.818
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