DUBLIN, May 17, 2019 /PRNewswire/ -- Allergan plc
(NYSE: AGN) today announced the expansion of the PLEDGE program
with a fifth study now evaluating relamorelin, an investigational,
ghrelin agonist being studied for the treatment of diabetic
gastroparesis (DG). Recruitment remains underway for the pivotal
Phase 3 studies RLM-MD-01 and RLM-MD-02. Patients who complete 52
weeks of the Phase 3 program will now be eligible for the RLM
3071-305-020 open-label study to evaluate the long-term safety of
the investigational drug.
This new study (RLM 3071-305-020) will follow participants for
up to five years to provide additional information on the long-term
safety profile of relamorelin.1 It also
enables eligible patients to potentially have access to relamorelin
until it is commercially available. The clinical goal of this study
is to collect additional information on the long-term safety of
relamorelin in this highly challenging patient
population.1
Diabetes is the leading cause of gastroparesis and affects
millions of diabetic
patients.2 It is a disorder in which there is a
substantial delay in stomach emptying and is characterized by
nausea, vomiting, bloating, and other gastrointestinal
complications.3 This delay can worsen a
patient's diabetes by making it more difficult to manage blood
sugar,3 which is of paramount importance to patients
with diabetes.4
"The goal of managing diabetes is to keep blood sugar levels
within a safe range. This is problematic in people with diabetic
gastroparesis, or DG, because they cannot predict when the food or
medicine will be absorbed and what impact this delay will have on
their blood sugar levels," said Dr. Brian
E. Lacy, MD, PhD, Gastroenterologist at Mayo Clinic
Jacksonville. "New research, as done through the current PLEDGE
program, is greatly needed as there are currently limited
therapeutic options for patients living with DG."
PLEDGE is a multi-study, patient-centric program designed to
evaluate the safety and efficacy of relamorelin in people with DG.
Allergan initiated the PLEDGE program following the results of a
Phase 2b study that showed
improvements in many of the core symptoms of DG compared to
placebo.5
"The PLEDGE program is one of Allergan's many commitments to
patients that could change treatment paradigms across
gastroenterology," said David
Nicholson, Chief R&D Officer, Allergan. "We're eager to
continue enrolling additional patients and remain dedicated to
helping the millions of people suffering from the debilitating
effects of DG."
For more information on the PLEDGE program, or to participate,
visit www.AllerganDG.com.
More About Relamorelin
Relamorelin is a potent ghrelin agonist in development for the
treatment of diabetic gastroparesis.6 Relamorelin is
administered via subcutaneous injection.7 The U.S. Food
and Drug Administration (FDA) has granted Fast Track designation to
relamorelin for the treatment of diabetic gastroparesis.
More About the PLEDGE Clinical Research Program
PLEDGE consists of five studies with up to a five-year
commitment.:
- RLM-MD-01 and RLM-MD-02 are two identical, pivotal, 12-week,
randomized, double-blind, placebo-controlled studies evaluating the
safety and efficacy of relamorelin compared to
placebo;7,8 Currently enrolling;
- RLM-MD-03 is a long-term extension roll-over (from -01 and -02)
placebo-controlled trial that evaluates the safety and efficacy of
relamorelin treatment for up to one year;9
- RLM-MD-04 is a non-pivotal 12-month study in less severe DG
patients evaluating the safety and efficacy of relamorelin
treatment;10
- RLM 3071-305-020 is a Phase 3b
open-label extension trial which will enroll patients who complete
either -03 or -04.5
More About Diabetic Gastroparesis
Diabetic gastroparesis is a disorder in patients with diabetes
in which there is a substantial delay in stomach emptying with
characteristic signs and symptoms of vomiting, nausea, abdominal
pain, early satiety, postprandial fullness, and
bloating.3 Moderate to severe diabetic gastroparesis
results in significant debility and hospitalizations and can
interfere with nutrition and the absorption of
medications.11 Up to 50 percent
of patients with type 1 and type 2 diabetes have been found to have
delayed gastric emptying.12 However, diagnosed
prevalence of symptomatic diabetic gastroparesis has been estimated
to be as low as five percent of patients with type 1 diabetes and
one percent of patients with type 2 diabetes, possibly reflecting
under-recognition in clinical practice.2 There is
high unmet need in this patient population as available therapies
to treat this disorder are limited and may exhibit significant side
effects.13
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical
leader focused on developing, manufacturing and commercializing
branded pharmaceutical, device, biologic, surgical and regenerative
medicine products for patients around the world. Allergan markets a
portfolio of leading brands and best-in-class products primarily
focused on four key therapeutic areas including medical aesthetics,
eye care, central nervous system and gastroenterology. As part of
its approach to delivering innovation for better patient care,
Allergan has built one of the broadest pharmaceutical and device
research and development pipelines in the industry.
With colleagues and commercial operations located in
approximately 100 countries, Allergan is committed to working with
physicians, healthcare providers and patients to deliver innovative
and meaningful treatments that help people around the world live
longer, healthier lives every day.
For more information, visit Allergan's website
at www.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective on existing trends and
information as of the date of this release. Actual results may
differ materially from Allergan's current expectations depending
upon a number of factors affecting Allergan's business. These
factors include, among others, the difficulty of predicting the
timing or outcome of FDA approvals or actions, if any; the impact
of competitive products and pricing; market acceptance of and
continued demand for Allergan's products; the impact of uncertainty
around timing of generic entry related to key products, including
RESTASIS®, on our financial results; risks associated
with divestitures, acquisitions, mergers and joint ventures; risks
related to impairments; uncertainty associated with financial
projections, projected cost reductions, projected debt reduction,
projected synergies, restructurings, increased costs, and adverse
tax consequences; difficulties or delays in manufacturing; and
other risks and uncertainties detailed in Allergan's periodic
public filings with the Securities and Exchange Commission,
including but not limited to Allergan's Annual Report on Form 10-K
for the year ended December 31, 2018
and Allergan's Quarterly Report on Form 10-Q for the period ended
March 31, 2019. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements.
CONTACTS:
Allergan:
Investors:
Manisha
Narasimhan, PhD
(862) 261-7162
Media:
Amy Rose
(862) 289-3072
1
|
Allergan. (2018).
Diabetic Gastroparesis Study 05. (ClinicalTrials.gov Identifier:
NCT03786380). Retrieved from
https://clinicaltrials.gov/ct2/show/NCT03786380
|
2
|
Choung RS, Locke GR
3rd, Schleck CD, Zinsmeister AR, Melton LJ 3rd, Talley NJ. Risk of
gastroparesis in subjects with type 1 and 2 diabetes in the general
population. Am J Gastroenterol. 2011;107(1):82–88.
doi:10.1038/ajg.2011.310
|
3
|
Gastroparesis. (2017,
October 16). Retrieved from
http://www.diabetes.org/living-with-diabetes/complications/gastroparesis.html
|
4
|
Tight Diabetes
Control. (2018, January 7). Retrieved from
http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/tight-diabetes-control.html
|
5
|
Camilleri, M.,
McCallum, R. W., Tack, J., Spence, S. C., Gottesdiener, K., &
Fiedorek, F. T. (2017). Efficacy and Safety of Relamorelin in
Diabetics With Symptoms of Gastroparesis: A Randomized,
Placebo-Controlled Study. Gastroenterology, 153(5),
1240-1250.e2.
|
6
|
Camilleri, M., &
Acosta, A. (2014). Emerging treatments in Neurogastroenterology:
relamorelin: a novel gastrocolokinetic synthetic ghrelin agonist.
Neurogastroenterology and motility : the official journal of the
European Gastrointestinal Motility Society, 27(3),
324-32.
|
7
|
Allergan. (2018). A
Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis.
(ClinicalTrials.gov Identifier: NCT03285308). Retrieved from
https://clinicaltrials.gov/ct2/show/NCT03285308
|
8
|
Allergan. (2018).
Study to Evaluate the Safety and Efficacy of Relamorelin in
Patients With Diabetic Gastroparesis Study 02. (ClinicalTrials.gov
Identifier: NCT03426345). Retrieved from
https://clinicaltrials.gov/ct2/show/NCT03426345
|
9
|
Allergan. (2018). A
Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis
Study 03. (ClinicalTrials.gov Identifier: NCT03420781). Retrieved
from https://clinicaltrials.gov/ct2/show/NCT03420781
|
10
|
Allergan. (2017). A
Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis
Study 04. (ClinicalTrials.gov Identifier: NCT03383146). Retrieved
from https://clinicaltrials.gov/ct2/show/NCT03383146
|
11
|
Krishnasamy, S.,
& Abell, T. L. (2018). Diabetic Gastroparesis: Principles and
Current Trends in Management. Diabetes therapy : research,
treatment and education of diabetes and related disorders, 9(Suppl
1), 1-42.
|
12
|
Gastroparesis.
(2012). Retrieved from
https://rarediseases.org/rare-diseases/gastroparesis/
|
13
|
Parkman HP, Fass R,
Foxx-Orenstein AE. Treatment of patients with diabetic
gastroparesis. Gastroenterol Hepatol (N Y).
2010;6(6):1-16.
|
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SOURCE Allergan plc