Apnimed Announces Completion of Enrollment in Phase 3 LunAIRo Study of AD109, the Potential First Nighttime Oral Treatment for Obstructive Sleep Apnea
09 Mayo 2024 - 7:00AM
Apnimed, a clinical-stage pharmaceutical company focused on
developing oral pharmacologic therapies for the treatment of
obstructive sleep apnea (OSA) and related disorders, announced the
early completion of enrollment in its LunAIRo Phase 3 study
designed to examine the efficacy and safety of its lead candidate
AD109 (aroxybutynin/atomoxetine) compared to placebo at six months
and one year. The company believes AD109 has the potential to be
the first nighttime oral pharmacologic treatment for people with
OSA who are either intolerant of or refuse to use positive airway
pressure (PAP) therapy. Apnimed’s second, large pivotal Phase 3
randomized controlled trial, SynAIRgy, is continuing its
enrollment. Topline Phase 3 data for both LunAIRo and SynAIRgy are
expected in Mid-2025.
OSA is one of the most common and serious sleep disorders,
affecting more than 50 million and as many as 80 million people in
the United States and nearly one billion worldwide. Unlike many
other common chronic disorders, OSA is vastly underdiagnosed and
undertreated, representing a major potential opportunity to build
awareness driven by new innovations in the field. OSA significantly
impairs daily function and increases one’s risk for serious
comorbidities like hypertension, diabetes, cardiovascular disease
and stroke.
“There are no FDA-approved drugs currently available to address
the neuromuscular dysfunction that causes OSA. The LunAIRo Study is
designed to evaluate the potential of AD109 to address the
underlying neurobiology of OSA by activating the upper airway
muscles and maintaining an open airway during sleep,” said Sanjay
R. Patel, MD, primary investigator in
the LunAIRo clinical study and Director, UPMC
Comprehensive Sleep Disorders Clinical Program in Pittsburgh,
Pennsylvania. “Because fewer than half of the people who are
prescribed devices such as PAP therapy consistently use them long
term and many others cannot or will not use them, new options are
urgently needed to address the chronic undertreatment of OSA among
millions of Americans.”
LunAIRo at ATS 2024 International
Conference
The rationale and design of the LunAIRo Phase 3 Study will be
featured in a poster presentation at the American Thoracic
Society’s (ATS) International Conference in San Diego, California,
on May 20, 2024. The LunAIRo Study is a randomized, double blind,
placebo-controlled, parallel-arm 1-year study of AD109 in adults
with OSA who are intolerant of or refuse PAP therapy. The LunAIRo
study examines the use of AD109 in a range of OSA patients across
all types of OSA from mild to severe and ranges of body mass index
(BMI) from normal to obese.
“We completed the enrollment of LunAIRo ahead of schedule,
signaling that there is strong interest in innovative new
approaches to treating OSA among both clinicians and people with
OSA,” said Larry Miller, MD, Chief Executive Officer of Apnimed.
“Studying AD109 across a broad range of people who have OSA is an
important consideration in the LunAIRo Study. We believe AD109
represents a significant market opportunity, with the potential to
help patients with OSA across a broad spectrum of severity and
BMI.”
Presentation Details: |
POSTER: |
7597 |
|
Aroxybutynin and Atomoxetine
(AD109) for the Treatment of OSA: Rationale and Design of the
LunAIRo Phase 3 Randomized, Controlled Clinical Trial |
Session: |
B80-3: OSA 2.0: LEVELING
UP THE SLEEP APNEA TOOL KIT |
Time: |
Monday, May 20, 11:30-1:15 PM
PT |
Location: |
San Diego Convention Center,
Area D (Hall A-B2, Ground Level) |
Presenter: |
Sanjay R. Patel, MD, principal
investigator of the LunAIRo Study and Director, |
|
UPMC Comprehensive Sleep
Disorders Clinical Program in Pittsburgh, Pennsylvania |
|
|
About the LunAIRo studyThe LunAIRo Study
(clinicaltrials.gov identifier NCT05811247) is a randomized, double
blind, placebo-controlled, parallel-arm 1-year study of a fixed
dose combination of aroxybutynin/atomoxetine (AD109) in
participants with OSA who are intolerant of or currently refuse
positive airway pressure (PAP) therapy. Participants (n=660) were
randomized 1:1 to either AD109 or placebo. The primary endpoint is
designed to show that AD109 is safe and superior to placebo in
reduction of airway obstructions (AHI4). A key secondary endpoint
is determining whether AD109 is superior to placebo for OSA
symptoms based on the PROMIS-Fatigue scale. Other standard
objective and subjective metrics of OSA will also be evaluated. The
trial enrolled patients from 64 centers across the US.
About AD109AD109 has the potential to be the
first oral drug that could both treat the underlying nighttime
airway obstruction and hypoxia that characterize OSA, as well as
improve the daytime consequences of OSA, such as fatigue. It is a
potential first-in-class, novel, investigational combination dosed
once daily at bedtime and is designed to treat OSA patients across
a broad spectrum of disease severity. AD109 combines Apnimed’s
novel selective antimuscarinic (aroxybutynin) with a selective
norepinephrine reuptake inhibitor (atomoxetine). AD109 targets key
neurological pathways in OSA that activate upper airway dilator
muscles to maintain an open airway during sleep. AD109 has the
potential to become a safe, effective, and convenient treatment for
OSA, addressing some of the key limitations of approved treatments
that are often poorly tolerated (e.g., CPAP and oral devices)
and/or invasive (e.g., surgery or implanted devices).
AD109 has been granted Fast Track designation by the FDA and is
currently in Phase 3 clinical trials.
About Obstructive Sleep ApneaObstructive Sleep
Apnea is one of the most common and serious sleep disorders. It is
estimated to affect more than 50 million and as many as 80 million
people in the United States, though underdiagnosis continues to be
a serious problem and the number of affected Americans may be far
greater. OSA impacts people across the spectrum of sex, age,
ethnicity and BMI ranges from normal to obese. OSA is characterized
by partial or complete upper airway closure that occurs during
sleep, which can cause dramatic reductions in overnight oxygen
levels and often leads to poor sleep, and in the long term, has
been shown to increase the risk of hypertension, diabetes,
cardiovascular disease, and stroke. Additionally, OSA can impair
work productivity, reduce daytime functional abilities, and lower
quality of life. Sleep-related muscular dysfunction driven by the
central nervous system is the key neurologic mechanism that causes
a reduction in neuromuscular control of the upper airway during
sleep. The vast majority of diagnosed patients are prescribed
positive air pressure therapy devices such as continuous positive
airway pressure, or CPAP, but many patients are dissatisfied with
these mechanical nighttime devices and fewer than half are
compliant long term, leaving a significant population untreated,
undertreated and at risk. Some OSA patients are overweight or
obese, and sustained weight loss can reduce the severity of airway
collapse and some symptoms. However, even substantial weight loss
may not fully address the symptoms of OSA or reduce the need for
treatments that help maintain an open airway during sleep, and if
patients regain weight OSA and its symptoms tend to return.
About ApnimedApnimed is a clinical-stage
pharmaceutical company working to transform the treatment of sleep
apnea based on a simple idea – patients with obstructive sleep
apnea could benefit from treatment with a safe and effective oral
medication dosed once daily at bedtime. Apnimed’s lead development
program, AD109, targets the neurologic control of upper airway
muscles to maintain an open airway during sleep. Based in
Cambridge, Mass., the company is developing a portfolio of novel
pharmacologic therapies for sleep apnea and related disorders.
Apnimed has a pipeline of novel, oral pharmacologic programs
including several that are part of our Joint Venture with Shionogi
& Co., Ltd. called Shionogi-Apnimed Sleep Science, LLC. Learn
more at apnimed.com or follow us
on X and LinkedIn.
Media Contact:Amanda
BreedingScientPRamanda@scientpr.com
Investor Contact:Wendy GabelKendall Investor
Relationswgabel@kendallir.com