DUBLIN and BOSTON, Oct. 27,
2016 /PRNewswire/ -- Allergan plc. (NYSE: AGN), a
leading global pharmaceutical company and Rhythm Holding Company,
LLC, which owns Motus Therapeutics, Inc. a biopharmaceutical
company developing peptide therapeutics for the treatment of
gastrointestinal (GI) disorders, announced today the top line
results of a Phase 2b clinical trial assessing the efficacy and
safety of relamorelin (RM-131),
Motus' ghrelin agonist, for the treatment of gastroparesis in
patients with type 1 and type 2 diabetes. Allergan also announced
that it has exercised its option to acquire Motus
Therapeutics. Motus (formerly known as Rhythm Health) is a
wholly-owned subsidiary of Rhythm Holding Company, LLC.
In the Phase 2b study, relamorelin administered for 12 weeks
demonstrated substantial efficacy for the key diabetic
gastroparesis symptoms of nausea, post-prandial fullness, abdominal
pain and bloating (measured both individually and as a composite
endpoint), along with a potent prokinetic effect on gastric
motility. Patients receiving relamorelin also experienced an
approximately 75 percent reduction in vomiting frequency across all
doses compared to baseline (the primary endpoint), similar to the
effect seen in the Phase 2a trial. However, an unusually high
placebo response for vomiting frequency, extending well beyond that
expected from previous studies, limited the ability to demonstrate
treatment efficacy on the vomiting frequency endpoint.
"The clinical results with relamorelin in this Phase 2b trial in
diabetic gastroparesis are very encouraging. Based on these
results and the results observed in the earlier phase 2a trial,
Allergan has exercised its option to acquire Motus Therapeutics and
intends to initiate Phase 3 clinical trials of relamorelin," said
David Nicholson, Executive Vice
President of Global Research and Development for Allergan. "We very
much look forward to sharing this phase 2b data with the US Food
and Drug Administration and to discussing our plans to conduct
Phase 3 trials."
The Phase 2b trial was designed to evaluate the effect of
relamorelin on the key signs and symptoms of gastroparesis
identified in the draft FDA guidance for gastroparesis, as well as
gastric emptying and safety in patients with moderate to severe
diabetic gastroparesis and with symptoms of vomiting at baseline.
The randomized, double-blind, placebo-controlled study evaluated
the safety and efficacy of dosing regimens ranging from 10 to 100
mcg administered twice daily over three months. The trial enrolled
393 patients with diabetic gastroparesis at clinical sites in the
U.S. and Europe.
"Patients with diabetic gastroparesis suffer greatly and have
very limited treatment options," said Michael Camilleri, MD, gastroenterologist at
Mayo Clinic who was an advisor on the design and interpretation of
the study. "The findings in this trial support initiating Phase 3
clinical trials to confirm these Phase 2b results with relamorelin
for the treatment of moderate to severe diabetic
gastroparesis."
"There has not been a drug approved for gastroparesis by the FDA
since 1983. Relamorelin may offer a much needed
opportunity for patients with diabetic gastroparesis to have
symptom relief and improved quality of life, said Richard McCallum, MD, of Texas Tech University." It is particularly
impressive that relamorelin can be delivered through SC injections
because these patients are not able to absorb medications once they
start vomiting. Relamorelin may be a major advance in the
armamentarium of physicians who manage diabetic gastroparesis."
Overall, relamorelin was safe and well-tolerated in the phase 2b
study with high compliance and completion rates over the course of
the study. There was some evidence of dose-related adverse
events related to worsening of glycemic control in some
patients.
Motus Therapeutics previously completed a successful 4-week
Phase 2 clinical trial of relamorelin in diabetic gastroparesis, in
which patients treated with relamorelin 10 mcg twice daily
demonstrated statistically significant improvements in gastric
emptying and vomiting frequency and in a pre-specified subgroup
also showed statistically significant improvements in the other
symptoms of gastroparesis.
"We are very excited that Allergan has exercised its option to
acquire Motus and that relamorelin will now advance into Phase 3
trials," said Bart Henderson,
President and Founder of Rhythm Holding. "Relamorelin has enormous
potential to improve the lives of patients with GI functional
disorders, and Allergan has the skill and resources to develop and
commercialize this promising drug to its fullest potential."
"The need for better treatments for diabetic gastroparesis is
urgent," said Keith Gottesdiener,
MD, CEO of Rhythm Holding. "This is a devastating condition that
affects several million people in the U.S., with only one drug
approved by the FDA in the past 30 years. In this clinical trial,
relamorelin improves gastric function, and shows substantial
efficacy for the debilitating symptoms of DG. We thank
everyone who has participated in this clinical trial. And we thank
Allergan for joining with us to help advance this potentially
breakthrough treatment for patients who may benefit from it."
Rhythm Holding and Allergan plan to submit the data for
presentation at a major gastrointestinal medical conference in
2017.
About the Acquisition
As a result of exercising its option to acquire Motus
Therapeutics, Allergan will pay the exercise price of $200 million at closing to Rhythm Holding. In
addition, Rhythm Holding will be eligible for a contingent payment
upon first commercial sale of relamorelin. Allergan previously made
$47 million in payments related to
the option-to-acquire Motus and the relamorelin Phase 2b clinical
trial. Completion of Allergan's acquisition of Motus Therapeutics
is expected to occur by the end of 2016 subject to customary
closing conditions.
About Relamorelin (RM-131)
Relamorelin is a potent ghrelin agonist in development for the
treatment of diabetic gastroparesis. Derived from the natural
ghrelin sequence, relamorelin has been optimized to stimulate
gastrointestinal (GI) motility, with greater potency and enhanced
stability and pharmacokinetics. The U.S. Food and Drug
Administration (FDA) has granted Fast Track review status to
relamorelin for the treatment of diabetic gastroparesis.
About Diabetic Gastroparesis
Diabetic gastroparesis is a disorder in which there is a
substantial delay in stomach emptying with characteristic symptoms
of vomiting, nausea, abdominal pain, early satiety, and bloating.
Moderate to severe diabetic gastroparesis results in significant
debility and hospitalizations and can interfere with nutrition and
the absorption of medications. Gastroparesis affects between 11 and
21 percent of the 29 million diabetics in the U.S; an estimated 2.3
million type 1 and type 2 diabetic patients with moderate or severe
gastroparesis symptoms are seeking treatment. Available therapies
to treat this disorder are limited and exhibit significant side
effects. No new therapies have been approved in the U.S. for the
treatment of gastroparesis in more than 30 years.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global
pharmaceutical company and a leader in a new industry model -
Growth Pharma. Allergan is focused on developing, manufacturing and
commercializing branded pharmaceuticals, devices and biologic
products for patients around the world. Allergan markets a
portfolio of leading brands and best-in-class products for the
central nervous system, eye care, medical aesthetics and
dermatology, gastroenterology, women's health, urology and
anti-infective therapeutic categories. Allergan is an industry
leader in Open Science, the Company's R&D model, which defines
our approach to identifying and developing game-changing ideas and
innovation for better patient care. This approach has led to
Allergan building one of the broadest development pipelines in the
pharmaceutical industry with 65+ mid-to-late stage pipeline
programs in development. Our Company's success is powered by our
more than 16,000 global colleagues' commitment to being Bold for
Life. Together, we build bridges, power ideas, act fast and drive
results for our customers and patients around the world by always
doing what is right. With commercial operations 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. For more information, visit Allergan's
website at www.Allergan.com.
About Motus and Rhythm Holding
Motus ( www.motustx.com ) is a
biopharmaceutical company focused on developing peptide
therapeutics for the treatment of gastrointestinal (GI) diseases.
Motus, formerly Rhythm Health, Inc., is a subsidiary of Rhythm
Holding Company, LLC. Motus is developing the ghrelin peptide
agonist, relamorelin (RM-131.
Rhythm Pharmaceuticals, Inc. (www.rhythmtx.com) is
another subsidiary of Rhythm Holding Company, LLC, focusing
on developing peptide therapeutics for the treatment of rare
genetic deficiencies that result in life-threatening metabolic
disorders. Rhythm's lead peptide product candidate is
setmelanotide, a first-in-class melanocortin 4 receptor (MC4R)
agonist for the treatment of rare genetic disorders of obesity. The
companies are based in Boston,
Massachusetts.
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 of existing trends and
information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements. 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, successful consummation and integration of
the acquisition of Motus Therapeutics and the ability to recognize
the anticipated benefits of the acquisition of Motus Therapeutics;
the anticipated size of the markets and anticipated demand for
Motus Therapeutics' products; the impact of competitive products
and pricing; the inherent uncertainty associated with financial
projections; periodic dependence on a small number of products for
a significant source of net revenue or income; variability of
trade-buying patterns; changes in generally accepted accounting
principles; the risks and uncertainties normally incident to the
pharmaceutical industry; risks that the carrying values of assets
may be negatively impacted by future events and circumstances; the
timing and success of product launches; the difficulty of
predicting the timing or outcome of product development efforts and
regulatory agency approvals or actions, if any; market acceptance
of and continued demand for Allergan's and Motus Therapeutics'
products; costs and efforts to defend or enforce intellectual
property rights; difficulties or delays in manufacturing; the
availability and pricing of third party sourced products and
materials; successful compliance with governmental regulations
applicable to Allergan's and Motus Therapeutics' facilities,
products and/or businesses; changes in the laws and regulations
affecting, among other things, pricing and reimbursement of
pharmaceutical products; 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, 2015 and Quarterly Report on Form
10-Q for the quarter ended June 30,
2016 (certain of such periodic public filings having been
filed under the "Actavis plc" name). Except as expressly required
by law, Allergan disclaims any intent or obligation to update these
forward-looking statements.
CONTACTS:
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Allergan
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Rhythm &
Motus
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Investors: Lisa
DeFrancesco
(862)
261-7152
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Bart Henderson
President & Founder
(857) 264-4281
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Media:
Mark Marmur
(973) 906-1526
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Adam Daley
Berry & Co.
(212) 253-8881
|
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SOURCE Allergan plc