THOUSAND OAKS, Calif.,
Nov. 30, 2020 /PRNewswire/
-- Three members of the COVID R&D Alliance - Amgen Inc.
(NASDAQ: AMGN), Takeda Pharmaceutical Co. Ltd. (NYSE: TAK), and UCB
(Euronext BR: UCB) - today announced the first patient enrolled in
the COMMUNITY Trial (COVID-19 Multiple Agents and Modulators
Unified Industry Members). COMMUNITY is a randomized, double-blind,
placebo-controlled, adaptive platform trial that enables an array
of therapeutic candidates to be studied in hospitalized COVID-19
patients.
With worldwide COVID-19 deaths exceeding one million and a
resurgence of cases globally, life science companies are working
urgently to identify treatments that can potentially reduce
clinical severity of COVID-19 in hospitalized
patients. COMMUNITY is the first platform trial designed and
launched by members of the COVID R&D Alliance, a group of more
than 20 leading pharmaceutical and biotech companies who are
devoting significant time, insights and company resources to speed
the development of potential therapies, novel antibodies, and
anti-viral therapies for COVID-19 and its related symptoms.
"As this insidious virus rapidly spreads around the globe,
doctors need options to treat hospitalized patients who are
actively sick and experiencing a range of symptoms as the disease
progresses," said David M. Reese,
M.D., Executive Vice President Research & Development, Amgen.
"Working hand-in-hand with our peers, we hope to find options that
could potentially save lives of the patients who will need
treatments for COVID-19 before widespread availability of a
vaccine."
COMMUNITY uses an adaptive design which allows for the addition,
removal and simultaneous study of multiple therapeutic candidates
during the course of the trial. Multiple candidates will be tested
against a shared placebo-controlled arm. The design allows for a
streamlined approach which may accelerate execution of the study
and save time as we search for therapeutics in the fight against
the pandemic. Immunomodulating therapies will be the first
candidates to enter COMMUNITY. Other therapies may join in the
future, such as antivirals.
The trial's design and global footprint were selected to address
potential barriers in the study of COVID-19 therapeutics. This
includes anticipating and activating trial sites to align with the
rise and fall of COVID cases across geographic regions as well as
streamlining an influx in trial-related inquiries faced by some
hospitals and health systems. COMMUNITY will onboard global sites
in the United States, Brazil, Mexico, Russia, South
Africa and other countries. This geographic diversity
will allow the trial sites to be active when cases spike locally.
COMMUNITY aims to simplify the study of investigational therapies
that may result in potential treatment options and address the
needs of hospitals in treating patients.
"COVID is not confined to one country, making it imperative that
we share the challenges, successes and insights in real-time," said
Dhavalkumar Patel, Executive Vice
President and Chief Scientific Officer, UCB. "By sharing our
expertise and resources, we hope to arm care teams with promising
investigational therapies to help patients who cannot wait."
Uncontrolled vascular and immune inflammatory responses have
proven to be hallmark symptoms in patients facing severe COVID-19
infections. These patients may face increased risk of acute
respiratory distress syndrome (ARDS), stroke and death. Initial
therapies entering into COMMUNITY were selected based upon their
potential to suppress or control the immune response or the
resulting inflammation. None of these therapies have been approved
by the FDA, EMA, or other health authorities for the treatment of
COVID-19 or its symptoms and are still investigational. These
include:
- Amgen's OTEZLA® (apremilast), which may suppress
immune response inflammation;
- Takeda's investigational intravenous administration of
lanadelumab, which modulates the kallikrein-kinin system and
suppresses production of bradykinin, potentially lessening
inflammation;
- UCB's zilucoplan, an investigational medicine that may reduce
overactivation of the immune system that contributes to ARDS.
OTEZLA entered COMMUNITY this week. It is expected lanadelumab
and zilucoplan will enter in the coming weeks. Other anti-viral,
immunomodulating and vascular agents may enter in the coming
months.
COMMUNITY is studying hospitalized COVID-19 patients. This
includes confirmed COVID-19 patients who may require either ongoing
medical care, supplemental oxygen, noninvasive ventilation or
high-flow oxygen devices, or invasive mechanical ventilation or
extracorporeal membrane oxygenation (ECMO). By enrolling both
hospitalized Intensive Care Unit and non-Intensive Care Unit
patients, the trial seeks to yield greater understanding of how
therapeutic interventions may be used with hospitalized COVID-19
patients experiencing a range of symptoms.
About COMMUNITY
COMMUNITY is an adaptive, randomized,
double-blind, placebo-controlled platform study designed to assess
multiple candidates as a potential treatment for hospitalized
patients with COVID-19, a disease caused by severe acute
respiratory syndrome coronavirus 2 (SARS CoV 2). The focus of the
trial is to identify an effective treatment(s) for hospitalized
COVID-19 patients, who are Grade 2 to Grade 5 on a Clinical
Severity Status 8-Point Ordinal Scale.
The primary endpoint of COMMUNITY is time to confirmed clinical
recovery without being re-hospitalized through Day 29 based on the
clinical severity status scale, which is defined as achieving a
score of 6, 7, or 8. Key secondary endpoints are oxygen-free
recovery, improvement from baseline or fit for discharge from
baseline, and all-cause mortality.
Patients will be randomized equally to either the candidate
agent plus the standard of care or a placebo plus standard of care
in a double-blind fashion. Patients who are randomized to placebo
plus standard of care will be subsequently randomized equally to a
matching placebo corresponding to an available agent.
About the COVID R&D Alliance
Organized in
March 2020, the COVID R&D
Alliance is operating unconstrained by past models of development
and is accelerating the study candidates without regard to company
affiliation. Members are sharing clinical trial data and real-world
evidence, as well as crowd-sourcing early stage candidates to
identify mechanisms and treatments that may be effective against
COVID-19. Initial efforts by the group focus on advancing well
understood therapies and late-stage investigational medicines for
hospitalized patients who need treatment options. Activities are
testing re-purposed molecules and early stage candidates. Member
companies have 40 trials expected to have findings in the coming
months.
Additional information on the COVID R&D Alliance is
available at www.CovidRDAlliance.com.
About Otezla®
(apremilast)
OTEZLA® (apremilast) is an oral
small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for
cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in
increased intracellular cAMP levels, which is thought to indirectly
modulate the production of inflammatory mediators. The specific
mechanism(s) by which OTEZLA exerts its therapeutic action in
patients is not well defined.
Otezla is currently approved for use in more than 50 countries
as an oral treatment for inflammatory diseases such as psoriasis
and psoriatic arthritis. By inhibiting PDE4, Otezla is thought to
modulate the production of inflammatory cytokines and other
mediators, which may prove helpful in inhibiting the inflammatory
response associated with the signs, symptoms and pulmonary
involvements observed in some COVID-19 patients. Amgen plans to
collaborate with platform trials to investigate Otezla in treatment
of hospitalized COVID-19 patients.
Otezla® (apremilast) U.S.
INDICATIONS
Otezla® (apremilast) is indicated for
the treatment of adult patients with moderate to severe plaque
psoriasis who are candidates for phototherapy or systemic
therapy.
Otezla is indicated for the treatment of adult patients with
active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with
oral ulcers associated with Behçet's Disease.
Otezla® (apremilast) U.S. IMPORTANT SAFETY
INFORMATION
Contraindications
- Otezla® (apremilast) is contraindicated in patients
with a known hypersensitivity to apremilast or to any of the
excipients in the formulation
Warnings and Precautions
- Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea,
nausea, and vomiting were associated with the use of Otezla. Most
events occurred within the first few weeks of treatment. In some
cases, patients were hospitalized. Patients 65 years of age or
older and patients taking medications that can lead to volume
depletion or hypotension may be at a higher risk of complications
from severe diarrhea, nausea, or vomiting. Monitor patients who are
more susceptible to complications of diarrhea or vomiting; advise
patients to contact their healthcare provider. Consider Otezla dose
reduction or suspension if patients develop severe diarrhea,
nausea, or vomiting
- Depression: Carefully weigh the risks and benefits of treatment
with Otezla for patients with a history of depression and/or
suicidal thoughts/behavior, or in patients who develop such
symptoms while on Otezla. Patients, caregivers, and families should
be advised of the need to be alert for the emergence or worsening
of depression, suicidal thoughts, or other mood changes, and they
should contact their healthcare provider if such changes occur
-
- Psoriasis: Treatment with Otezla is associated with an increase
in depression. During clinical trials, 1.3% (12/920) of patients
reported depression compared to 0.4% (2/506) on placebo. Depression
was reported as serious in 0.1% (1/1308) of patients exposed to
Otezla, compared to none in placebo-treated patients (0/506).
Suicidal behavior was observed in 0.1% (1/1308) of patients on
Otezla, compared to 0.2% (1/506) on placebo. One patient treated
with Otezla attempted suicide; one patient on placebo committed
suicide
- Psoriatic Arthritis: Treatment with Otezla is associated with
an increase in depression. During clinical trials, 1.0% (10/998)
reported depression or depressed mood compared to 0.8% (4/495)
treated with placebo. Suicidal ideation and behavior was observed
in 0.2% (3/1441) of patients on Otezla, compared to none in
placebo-treated patients. Depression was reported as serious in
0.2% (3/1441) of patients exposed to Otezla, compared to none in
placebo-treated patients (0/495). Two patients who received placebo
committed suicide compared to none on Otezla
- Behçet's Disease: Treatment with Otezla is associated with an
increase in depression. During the phase 3 clinical trial, 1%
(1/104) reported depression or depressed mood compared to 1%
(1/103) treated with placebo. No instances of suicidal ideation or
behavior were reported in patients treated with Otezla or treated
with placebo
- Weight Decrease: Monitor body weight regularly; evaluate
unexplained or clinically significant weight loss, and consider
discontinuation of Otezla
-
- Psoriasis: During clinical trials, body weight loss of 5-10%
occurred in 12% (96/784) of patients treated with Otezla and in 5%
(19/382) of patients treated with placebo. Body weight loss of ≥10%
occurred in 2% (16/784) of patients treated with Otezla compared to
1% (3/382) of patients treated with placebo
- Psoriatic Arthritis: During clinical trials, body weight loss
of 5-10% was reported in 10% (49/497) of patients taking Otezla and
in 3.3% (16/495) of patients taking placebo
- Behçet's Disease: During the phase 3 clinical trial, body
weight loss of >5% was reported in 4.9% (5/103) of patients
taking Otezla and in 3.9% (4/102) of patients taking placebo
- Drug Interactions: Apremilast exposure was decreased when
Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy
may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin,
phenobarbital, carbamazepine, phenytoin) is not recommended
Adverse Reactions
- Psoriasis: Adverse reactions reported in ≥5% of patients were
(Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper
respiratory tract infection (9, 6), tension headache (8, 4), and
headache (6, 4)
- Psoriatic Arthritis: Adverse reactions reported in at least 2%
of patients taking Otezla, that occurred at a frequency at least 1%
higher than that observed in patients taking placebo, for up to 16
weeks (after the initial 5-day titration), were (Otezla%,
placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9,
2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2,
0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0,
0.2)
- Behçet's Disease: Adverse reactions reported in at least ≥5% of
patients taking Otezla, that occurred at a frequency at least 1%
higher than that observed in patients taking placebo, for up to 12
weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea
(19.2, 10.7); headache (14.4, 10.7); upper respiratory tract
infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting
(8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract
infection (6.7, 4.9); arthralgia (5.8, 2.9)
Use in Specific Populations
- Pregnancy: Otezla has not been studied in pregnant women.
Advise pregnant women of the potential risk of fetal loss. Consider
pregnancy planning and prevention for females of reproductive
potential. There is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to Otezla during pregnancy.
Information about the registry can be obtained by calling
1-877-311-8972 or visiting
https://mothertobaby.org/ongoing-study/otezla/
- Lactation: There are no data on the presence of apremilast or
its metabolites in human milk, the effects of apremilast on the
breastfed infant, or the effects of the drug on milk production.
The developmental and health benefits of breastfeeding should be
considered along with the mother's clinical need for Otezla and any
potential adverse effects on the breastfed child from Otezla or
from the underlying maternal condition
- Renal Impairment: Otezla dosage should be reduced in patients
with severe renal impairment (creatinine clearance less than 30
mL/min) for details, see Dosage and Administration, Section 2, in
the Full Prescribing Information
Please click here for Otezla® Full Prescribing
Information.
About lanadelumab
Lanadelumab is a fully human monoclonal antibody that
specifically binds and inhibits plasma kallikrein activity.
Lanadelumab is produced in Chinese Hamster Ovary (CHO) cells by
recombinant DNA technology.
Based on its mechanism of action, lanadelumab may prevent the
pro-inflammatory effects of SARS-COV2 and the extravasation and
accumulation of fluid within the lungs during a serious and
prolonged COVID-19 illness by decreasing plasma kallikrein activity
and regulating excess bradykinin signaling. In addition,
lanadelumab-induced plasma kallikrein inhibition may help to reduce
inflammation and coagulation driven by FXII, which is activated by
plasma kallikrein through a positive feedback loop. An
investigational intravenous administration of lanadelumab is being
studied.
Lanadelumab (marketed under the tradename TAKHZYRO®)
is approved as a subcutaneous formulation for prophylaxis to
prevent attacks of hereditary angioedema (HAE) in patients ≥12
years of age.
U.S. INDICATION AND IMPORTANT SAFETY
INFORMATION
INDICATION
TAKHZYRO (lanadelumab-flyo) is indicated for
prophylaxis to prevent attacks of hereditary angioedema (HAE) in
patients ≥12 years of age.
IMPORTANT SAFETY INFORMATION
Hypersensitivity
reactions have been observed. In case of a severe
hypersensitivity reaction, discontinue TAKHZYRO administration and
institute appropriate treatment.
Adverse Reactions: The most commonly observed adverse
reactions (≥10% and higher than placebo) associated with TAKHZYRO
were injection site reactions consisting mainly of pain, erythema,
and bruising at the injection site; upper respiratory infection;
headache; rash; myalgia; dizziness; and diarrhea. Less common
adverse reactions observed included elevated levels of
transaminases; one patient discontinued the trial for elevated
transaminases.
Use in Specific Populations: The safety and efficacy of
TAKHZYRO in pediatric patients <12 years of age have not been
established.
No data are available on TAKHZYRO in pregnant women. No data are
available on the presence of lanadelumab in human milk or its
effects on breastfed infants or milk production.
To report SUSPECTED ADVERSE REACTIONS, contact Dyax Corp., a
Takeda company, at 1-800-828-2088, or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
For U.S. audiences, please see the full Prescribing
Information including Patient Information for
TAKHZYRO®.
About Zilucoplan
Zilucoplan, an investigational drug
product, is a once-daily self-administered, subcutaneous peptide
inhibitor of C5 which is in Phase III development for the treatment
of generalized Myasthenia Gravis (gMG). Zilucoplan is also being
investigated in immune-mediated necrotizing myopathy (IMNM),
amyotrophic lateral sclerosis (ALS) and other tissue-based
complement-mediated disorders. Zilucoplan has not been approved by
any regulatory authority for any indication.
About Amgen
Amgen is committed to unlocking
the potential of biology for patients suffering from serious
illnesses by discovering, developing, manufacturing, and delivering
innovative human therapeutics. This approach begins by using tools
like advanced human genetics to unravel the complexities of disease
and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its biologics manufacturing expertise to strive for
solutions that improve health outcomes and dramatically improve
people's lives. A biotechnology pioneer since
1980, Amgen has grown to be the world's largest
independent biotechnology company, has reached millions of patients
around the world and is developing a pipeline of medicines with
breakaway potential.
For more information, visit www.amgen.com and follow
us on www.twitter.com/amgen.
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including any statements on the
outcome, benefits and synergies of collaborations, or potential
collaborations, with any other company, including BeiGene, Ltd. or
any collaboration or potential collaboration in pursuit of
therapeutic antibodies against COVID-19 (including statements
regarding such collaboration's, or our own, ability to discover and
develop fully-human neutralizing antibodies targeting SARS-CoV-2 or
antibodies against targets other than the SARS-CoV-2 receptor
binding domain, and/or to produce any such antibodies to
potentially prevent or treat COVID-19), or the Otezla®
(apremilast) acquisition (including anticipated Otezla sales growth
and the timing of non-GAAP EPS accretion), as well as estimates of
revenues, operating margins, capital expenditures, cash, other
financial metrics, expected legal, arbitration, political,
regulatory or clinical results or practices, customer and
prescriber patterns or practices, reimbursement activities and
outcomes, effects of pandemics or other widespread health problems
such as the ongoing COVID-19 pandemic on Amgen's business,
outcomes, progress, or effects relating to studies of Otezla as a
potential treatment for COVID-19, and other such estimates and
results. Forward-looking statements involve significant risks
and uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission reports filed
by Amgen, including its most recent annual report on Form 10-K and
any subsequent periodic reports on Form 10-Q and current reports on
Form 8-K. Unless otherwise noted, Amgen is providing this
information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those Amgen projects. Discovery
or identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product.
The scientific information discussed in this news release
related to Amgen's product candidates is preliminary and
investigative. Such product candidates are not approved by the U.S.
Food and Drug Administration, and no conclusions can or should be
drawn regarding the safety or effectiveness of the product
candidates. Further, any scientific information discussed in this
news release relating to new indications for Amgen's products is
preliminary and investigative and is not part of the labeling
approved by the U.S. Food and Drug Administration for the products.
The products are not approved for the investigational use(s)
discussed in this news release, and no conclusions can or should be
drawn regarding the safety or effectiveness of the products for
these uses.
About Takeda Pharmaceutical Company Limited
Takeda
Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global,
values-based, R&D-driven biopharmaceutical leader headquartered
in Japan, committed to bringing
better health and a brighter future to patients by translating
science into highly-innovative medicines. Takeda focuses its
R&D efforts on four therapeutic areas: Oncology, Rare Diseases,
Neuroscience, and Gastroenterology (GI). We also make targeted
R&D investments in Plasma-Derived Therapies and Vaccines. We
are focusing on developing highly innovative medicines that
contribute to making a difference in people's lives by advancing
the frontier of new treatment options and leveraging our enhanced
collaborative R&D engine and capabilities to create a robust,
modality-diverse pipeline. Our employees are committed to improving
quality of life for patients and to working with our partners in
health care in approximately 80 countries.
For more information, visit https://www.takeda.com.
Takeda Forward-Looking Statements
This press release
and any materials distributed in connection with this press release
may contain forward-looking statements, beliefs or opinions
regarding Takeda's future business, future position and results of
operations, including estimates, forecasts, targets and plans for
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"projects" or similar expressions or the negative thereof. These
forward-looking statements are based on assumptions about many
important factors, including the following, which could cause
actual results to differ materially from those expressed or implied
by the forward-looking statements: the economic circumstances
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claims or concerns regarding the safety or efficacy of marketed
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impact of post-merger integration efforts with acquired companies;
the ability to divest assets that are not core to Takeda's
operations and the timing of any such divestment(s); and other
factors identified in Takeda's most recent Annual Report on Form
20-F and Takeda's other reports filed with the U.S. Securities and
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https://www.takeda.com/investors/reports/sec-filings/ or
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About UCB
UCB (www.ucb.com) is a global
biopharmaceutical company focused on the discovery and development
of innovative medicines and solutions to transform the lives of
people living with severe diseases of the immune system or of the
central nervous system. With 7,600 people in approximately 40
countries, the company generated revenue of €4.9 billion in 2019.
UCB is listed on Euronext Brussels (symbol: UCB).
UCB Forward-Looking Statements
This press release contains forward-looking statements based on
current plans, estimates and beliefs of management. All statements,
other than statements of historical fact, are statements that could
be deemed forward-looking statements, including estimates of
revenues, operating margins, capital expenditures, cash, other
financial information, expected legal, political, regulatory or
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nature, such forward-looking statements are not guarantees of
future performance and are subject to risks, uncertainties and
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Additionally, information contained in this document shall not
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any securities, nor shall there be any offer, solicitation or sale
of securities in any jurisdiction in which such offer, solicitation
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There is no guarantee that new product candidates in the
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SOURCE COVID R&D Alliance