MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced topline results from its pivotal Phase 3, randomized, double-blind, placebo-controlled clinical trial, CTH-300, that evaluated apomorphine sublingual film (APL-130277) in patients with Parkinson’s disease (PD) who experience motor fluctuations (OFF episodes). Study CTH-300 met its primary and key secondary endpoints, and the medicine was also generally well-tolerated by study participants.
Apomorphine sublingual film is being developed to treat all types of motor OFF episodes, including morning OFF, unpredictable OFF and end-of-dose wearing OFF. OFF episodes occur when PD symptoms, otherwise controlled by medications, re-emerge. OFF episodes can happen at any point during the day, often occurring in the morning after awakening and periodically throughout the day. OFF episodes are characterized, in part, by tremor, stiffness or slow movement. These episodes may disrupt a person’s ability to perform everyday activities and are burdensome for patients, family and caregivers. OFF episodes are experienced by as many as 40 to 60 percent of people with PD and may worsen in frequency and severity over the course of the illness.1
“For people with Parkinson’s disease and their families, OFF episodes can have a significant emotional and practical impact, and there are currently few treatment options for these events,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “Based on these topline results, we believe that apomorphine sublingual film has the potential to be a well-tolerated, reliable, convenient and fast-acting therapeutic option for people living with Parkinson’s disease who struggle with OFF episodes.”
The Phase 3 study met its primary endpoint, with initial results from 109 adults with PD showing that individuals with OFF episodes who received apomorphine sublingual film demonstrated a statistically significant mean reduction in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score from pre-dose to 30 minutes after dosing at Week 12 compared with the placebo group, with effects persisting until the last observed time point at 90 minutes.2 The difference in MDS-UPDRS Part III score change from baseline 30 minutes after dosing between apomorphine sublingual film and placebo was 7.6 (p=0.0002). The MDS-UPDRS Part III scale is used to assess the motor signs of PD.3 The study also met its key secondary endpoint, showing that a statistically significant greater percentage of people treated with apomorphine sublingual film (35 percent predicted response rate) had a patient-rated full ON response within 30 minutes after dosing at Week 12 compared with the placebo group (16 percent predicted response rate).2
“Apomorphine is a potent antiparkinsonian medication that is underutilized in Parkinson’s disease patients with troublesome OFF episodes. Apomorphine is currently only available as an injection. If an alternative method to deliver the medicine were approved, such as apomorphine sublingual film, it would be an important new option for healthcare providers and people with Parkinson’s disease,” said Stewart Factor, D.O., Professor of Neurology, Director of the Movement Disorders Program and Vance Lanier Chair of Neurology at Emory University School of Medicine, and the primary investigator on the CTH-300 study. “The study reported here demonstrated that sublingual apomorphine rapidly and safely converted people with Parkinson’s disease from the OFF to the ON state.”
Apomorphine sublingual film was generally well-tolerated in the study population. The most commonly reported treatment-emergent adverse events during both the titration and maintenance treatment phases were nausea (27.0 percent), somnolence (14.9 percent), dizziness (14.2 percent), yawning (12.8 percent) and headache (9.2 percent).
Full results of study CTH-300 are being analyzed and will be presented at a future scientific congress.
Results from the study will be used to support Sunovion’s submission of a New Drug Application (NDA) for apomorphine sublingual film that is expected in spring 2018. The FDA has granted Fast Track Designation (FTD) for apomorphine sublingual film. FTD is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions with the potential to address unmet medical needs.
About Apomorphine Sublingual Film
Apomorphine sublingual
film (APL-130277), a novel formulation of apomorphine, a dopamine
agonist, is being developed as a fast-acting, easy-to-use, sublingual
film for the on-demand management of OFF episodes associated with
Parkinson’s disease (PD). Apomorphine is the only molecule approved for
on-demand, intermittent treatment of OFF episodes for advanced PD
patients, but in the United States is currently approved as a
subcutaneous injection. Apomorphine sublingual film is designed to offer
a new, simple and discreet solution that can be used first thing in the
morning, up to five times throughout the day, which may help people with
PD rapidly, safely and reliably convert from the OFF to the ON state. It
is intended to serve as an on-demand adjunctive treatment with patients’
current levodopa treatment regimens to manage OFF episodes. Apomorphine
sublingual film is in Phase 3 clinical development and has not been
approved by the U.S. Food and Drug Administration (FDA). In October
2016, Sunovion acquired Cynapsus Therapeutics Inc. (Canadian Specialty
Central Nervous System Biotechnology Company), along with its product
candidate APL-130277.
About CTH-300
CTH-300 was a pivotal, 12-week, randomized,
double-blind, placebo controlled, parallel group, Phase 3 study
examining the efficacy, safety and tolerability of apomorphine
sublingual film (APL-130277) in people with levodopa-responsive
Parkinson’s disease (PD) complicated by OFF episodes. The study was
intended to demonstrate a statistically significant reduction in the
Movement Disorder Society Unified Parkinson's Disease Rating Scale
(MDS-UPDRS) Part III. The primary endpoint was a mean change from
pre-dose in MDS-UPDRS Part III Motor Examination at 30 minutes after
dosing at the 12-week visit of the Maintenance Treatment Phase. The
prospectively specified key secondary endpoint was the percentage of
people with a patient-rated full ON response within 30 minutes at the
12-week visit of the Maintenance Treatment Phase.2
About Parkinson’s Disease and OFF Episodes
More than one
million people in the U.S. and an estimated four to six million people
worldwide suffer from Parkinson’s disease (PD). PD is a chronic,
progressive neurodegenerative disease characterized by motor symptoms,
including tremor at rest, rigidity and impaired movement, as well as
significant non-motor symptoms, including cognitive impairment and mood
disorders. It is the second most common neurodegenerative disease behind
Alzheimer’s disease, and the prevalence of PD is increasing with the
aging of the population. OFF episodes are the re-emergence of symptoms
(motor and non-motor) otherwise controlled by medications. OFF episodes
occur when PD symptoms, otherwise controlled by medications, re-emerge.
OFF episodes can happen at any point during the day, often occurring in
the morning after awakening and periodically throughout the day. OFF
episodes are characterized, in part, by tremor, stiffness or slow
movement. These episodes may disrupt a person’s ability to perform
everyday activities and are burdensome for patients, family and
caregivers. OFF episodes are experienced by as many as 40 to 60 percent
of people with PD and may worsen in frequency and severity over the
course of the illness.4
About Sunovion Pharmaceuticals Inc. (Sunovion)
Sunovion is a
global biopharmaceutical company focused on the innovative application
of science and medicine to help people with serious medical conditions.
Sunovion’s vision is to lead the way to a healthier world. The company’s
spirit of innovation is driven by the conviction that scientific
excellence paired with meaningful advocacy and relevant education can
improve lives. With patients at the center of everything it does,
Sunovion has charted new paths to life-transforming treatments that
reflect ongoing investments in research and development and an
unwavering commitment to support people with psychiatric, neurological
and respiratory conditions. Sunovion’s track record of discovery,
development and/or commercialization of important therapies has included
Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution,
Utibron™ Neohaler® (indacaterol/glycopyrrolate) Inhalation Powder,
Seebri™ Neohaler® (glycopyrrolate) Inhalation Powder, Arcapta® Neohaler®
(indacaterol) Inhalation Powder, Brovana® (arformoterol tartrate)
Inhalation Solution, Latuda® (lurasidone HCI) and
Aptiom® (eslicarbazepine acetate).
Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the company’s websites: www.sunovion.com,www.sunovion.eu and www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon
Pharma is among the top-ten listed pharmaceutical companies in Japan
operating globally in major pharmaceutical markets, including Japan, the
United States, China and the European Union. Sumitomo Dainippon Pharma
aims to create innovative pharmaceutical products in the Psychiatry &
Neurology area and the Oncology area, which have been designated as the
focus therapeutic areas. Sumitomo Dainippon Pharma is based on the
merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo
Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about
6,500 employees worldwide. Additional information about Sumitomo
Dainippon Pharma is available through its corporate website at www.ds-pharma.com.
LATUDA and SUNOVION are registered trademarks of Sumitomo Dainippon
Pharma Co., Ltd.
BROVANA is a registered trademark of Sunovion
Pharmaceuticals Inc.
APTIOM is a registered trademark of BIAL, used
under license.
SEEBRI and UTIBRON are trademarks of Novartis AG,
used under license.
ARCAPTA and NEOHALER are registered trademarks
of Novartis AG, used under license.
LONHALA is a trademark of
Sunovion Pharmaceuticals Inc.
MAGNAIR is a trademark of PARI Pharma
GmbH, used under license.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon
Pharma Co., Ltd.
© 2018 Sunovion Pharmaceuticals
Inc. All rights reserved.
For a copy of this release, visit Sunovion’s website at www.sunovion.com
References
1 “Treating the ‘off’ periods in Parkinson’s.” Parkinson’s
Disease Foundation. Available online: http://www.pdf.org/en/fall03_periods.
Accessed February 2017.
2 Efficacy, Safety and
Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes
in Patients With Parkinson's Disease. Accessed December 2017, from https://clinicaltrials.gov/ct2/show/NCT02469090.
3
“Movement Disorder Society-Sponsored Revision of the Unified Parkinson’s
Disease Rating Scale (MDS-UPDRS): Scale Presentation and Clinimetric
Testing Results” International Parkinson and Movement Disorder Society.
Available online: https://www.movementdisorders.org/MDS-Files1/PDFs/Rating-Scales/MDS-UPDRS_Vol23_Issue15_2008.pdf.
Accessed December 2017.
4 “Treating the ‘off’ periods in
Parkinson’s.” Parkinson’s Disease Foundation. Available online: http://www.pdf.org/en/fall03_periods.
Accessed February 2017.
