Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world’s
leading producers of plasma-derived medicines, today announced it
has met its enrollment target of 339 patients in SPARTA (Study of
ProlAstin-c Randomized Therapy with Alpha-1 augmentation;
NCT01983241), its phase 3 clinical trial designed to determine if
alpha-1- antitrypsin (AAT) deficiency (alpha-1) patients with
emphysema have a slower progression of lung tissue loss when
treated weekly with two separate dose regimens of Grifols
Prolastin®-C.
Alpha-1 is an underdiagnosed2 genetic disorder that can result
in chronic obstructive pulmonary disease (COPD), a group of
respiratory diseases that includes emphysema, which can occur when
a patient has low levels of alpha-1 antitrypsin (AAT), a protective
protein that safeguards the lungs. The currently approved dosage is
60 mg/kg in weekly infusions.
SPARTA, the largest randomized, double-blind, placebo-controlled
study on AAT augmentation therapy to-date, is designed to evaluate
the potential of Prolastin®-C to significantly reduce emphysema
progression in alpha-1 patients by raising AAT protein levels
through weekly administration of two active dose levels versus
placebo.
The clinical trial is taking place across 16 countries and more
than 50 sites. It will evaluate the efficacy and safety of two
separate dose regimens of Prolastin®-C (60 and 120 mg/kg/week)
versus placebo for 156 weeks (i.e., three years), measuring the
rate of pulmonary-tissue loss through whole lung computed
tomography (CT) densitometry as the primary measure of clinical
efficacy.
“While alpha-1 patients currently benefit from recommended AAT
augmentation therapy, we hope to show clinical evidence of benefit
with the current approved dose and a greater impact by doubling the
single dose to 120 mg/kg weekly,” said Sandra Camprubi, Grifols
Senior Director Clinical Operations. “We look forward to providing
topline data from this study in 2026 and evaluating the next
regulatory steps to provide emphysema patients impactful treatment
options for alpha-1.”
The company’s robust innovation pipeline
includes a strong commitment to supporting the alpha-1 community.
Earlier this year, Grifols launched its AlphaID™ At Home Genetic
Health Risk Service (AlphaID™ At Home), the first-ever free
direct-to-consumer program in the U.S. to screen for the genetic
risk of alpha-1.
About Alpha-1 and COPD
Alpha-1-antitrypsin deficiency, also known as alpha-1, is a
rarely diagnosed genetic disease that can result in chronic
obstructive pulmonary disease (COPD), a group of respiratory
diseases that includes emphysema, a lung condition that causes
shortness of breath. Patients who have alpha-1 have a genetic
deficiency of alpha-1 antitrypsin, a protective plasma protein that
safeguards the lungs from inflammation caused by infection and
inhaled irritants such as tobacco smoke. Alpha-1 is the major known
genetic risk factor for COPD3.
About
Prolastin®-C
PROLASTIN®-C is an alpha1-proteinase inhibitor (human)
(alpha1-PI) indicated for chronic augmentation and maintenance
therapy in adults with clinical evidence of emphysema due to severe
hereditary deficiency of alpha1-PI (alpha-1-antitrypsin
deficiency).
PROLASTIN®-C is contraindicated in immunoglobulin
A (IgA)-deficient patients with antibodies against IgA or
patients with a history of anaphylaxis or other severe systemic
reaction to alpha1-PI products. Hypersensitivity
reactions, including anaphylaxis, may occur. Monitor vital signs
and observe the patient carefully throughout the infusion. If
hypersensitivity symptoms occur, promptly stop PROLASTIN®-C
infusion and begin appropriate therapy. Because PROLASTIN®-C
is made from human plasma, it may carry a risk of transmitting
infectious agents, e.g., viruses, the
variant Creutzfeldt-Jakob disease (vCJD) agent, and,
theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
This also applies to unknown or emerging viruses and other
pathogens. The most common drug-related adverse reaction observed
at a rate of >5% in subjects receiving PROLASTIN®-C was upper
respiratory tract infection. The most serious adverse reaction
observed during clinical trials with PROLASTIN®-C was an abdominal
and extremity rash in 1 subject.
For full US Prescribing Information, please visit:
https://grifolsug-pi.com/inserts/Prolastin-C.pdf
Always refer to the Summary of Product Characteristics (SmPC)
and the local prescribing information of your country.
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 Lozano R, Naghavi M, Foreman K, et al. Global and regional
mortality from 235 causes of death for 20 age groups in 1990 and
2010: a systematic analysis for the Global Burden of Disease Study
2010. Lancet. 2012;380(9859):2095-2128. doi:
10.1016/S0140-6736(12)61728-02 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.168.7.8183 What
causes alpha-1 antitrypsin deficiency? National Heart, Lung, and
Blood Institute website.
https://www.nhlbi.nih.gov/health/health-topics/topics/aat/causes.
Updated October 11, 2011. Accessed June 28, 2023.
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