At 48 weeks, Allurion Balloon subjects had a
greater than 50% responder rate and substantially greater weight
loss than Control subjects
Low rate of serious adverse events supports
favorable safety profile of the Allurion Balloon
Fourth and final module of PMA submission
including AUDACITY trial data planned for 2025
Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to
ending obesity, today announced topline results from the AUDACITY
Food & Drug Administration (FDA) pivotal trial evaluating the
safety and efficacy of the Allurion Balloon.
The AUDACITY trial is an open-label, multicenter, randomized,
controlled study and is the first FDA pivotal trial on an
intragastric balloon for weight loss to report primary outcomes
beyond 9 months. 550 subjects were randomized 1:1 to either two
cycles of the Allurion Balloon1 or a control group that received
moderate intensity lifestyle therapy. Subjects in the treatment
group received their first Allurion Balloon at Week 0, which passes
at approximately Week 16, and a second Allurion Balloon at Week 24,
which passes at approximately Week 40. Co-primary endpoints based
on Allurion Balloon subject responders and a comparison of percent
total body weight loss between groups were measured at Week 48,
approximately eight weeks after the second Allurion Balloon passes
at Week 40.
The AUDACITY trial achieved its responder rate co-primary
endpoint by demonstrating that more than 50% of Allurion Balloon
subjects lost more than 5% of their total body weight at 48 weeks
(58%; p-value = 0.0089). At 48 weeks, Allurion Balloon subjects
exhibited substantially greater weight loss compared to control
subjects with a 3.77% mean difference in total body weight loss,
resulting in a 2.69% superiority margin. This margin was less than
the pre-specified 3% superiority margin needed to meet the
comparative co-primary endpoint (p-value=0.1616) and was impacted,
in part, by higher-than-expected weight loss in control subjects.
At 40 weeks, approximately when the second Allurion Balloon has
passed, the 4.22% mean difference in total body weight loss between
groups exceeded a 3% superiority margin.
The rate of serious adverse events in Allurion Balloon subjects
in the AUDACITY trial was 3.1%, the lowest reported in a pivotal
FDA trial for a liquid-filled intragastric balloon indicated for
weight loss.2
Based on the results of the AUDACITY trial, Allurion plans to
submit the fourth and final module of the Pre-Market Approval (PMA)
application to the FDA.
“I believe the results of the AUDACITY trial demonstrate a
favorable benefit-risk profile for people with obesity,” said Dr.
Shelby Sullivan, Professor of Medicine and Director, Endoscopic
Bariatric and Metabolic Program Center for Digestive Health at
Dartmouth-Hitchcock Health and Lead Investigator of the AUDACITY
trial. “If approved, the Allurion Balloon could fill a significant
gap in the treatment of obesity and serve as a valuable alternative
to GLP-1 medications.”
“Data from the AUDACITY trial demonstrate the Allurion Balloon’s
positive impact on weight loss and excellent safety record,” said
Dr. Ram Chuttani, Chief Medical Officer and Founding Partner of
Allurion. “We believe that the Allurion Balloon will be a novel and
very useful therapy for people in the United States living with
obesity.”
“We were pleased with the performance of the Allurion Balloon
subjects in the AUDACITY trial, where a majority of them were
responders while using the balloon alone, without the customized
digital platform that normally accompanies it commercially,” said
Dr. Shantanu Gaur, Founder and CEO of Allurion. “Our real-world
experience in over 150,000 patients outside the United States shows
that weight loss, exceeding that observed in AUDACITY, ranges from
14% with a single balloon cycle and up to 22% with two balloon
cycles when the Allurion Balloon is combined with the AI-powered
Virtual Care Suite3,4. The AUDACITY trial results further bolster
this rich data set on the safety and efficacy of the Allurion
Balloon. We are looking forward to submitting these data to the FDA
and advancing our PMA application toward FDA approval.”
Additional data on the AUDACITY trial will be presented at
upcoming medical meetings.
About Allurion
Allurion is dedicated to ending obesity. The Allurion Program is
a weight loss platform that features the Allurion Gastric Balloon,
the world’s first and only swallowable, Procedure-less™
intragastric balloon for weight loss, and offers access to the
Allurion Virtual Care Suite, including the Allurion Mobile App for
consumers, Allurion Insights for health care providers featuring
the Coach Iris AI Platform, and the Allurion Connected Scale. The
Allurion Virtual Care Suite is also available to providers
separately from the Allurion Program to help customize, monitor and
manage weight loss therapy for patients regardless of their
treatment plan: gastric balloon, surgical, medical or nutritional.
The Allurion Gastric Balloon is an investigational device in the
United States.
For more information about Allurion and the Allurion Virtual
Care Suite, please visit www.allurion.com.
Allurion is a trademark of Allurion Technologies, Inc. in the
United States and countries around the world.
Forward-Looking Statements
This press release may contain certain forward-looking
statements within the meaning of the U.S. federal and state
securities laws. These forward-looking statements generally are
identified by the words “believe,” “project,” “expect,”
“anticipate,” “estimate,” “intend,” “strategy,” “future,”
“opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,”
“will continue,” “will likely result,” and similar expressions and
include statements regarding: the timing of, and plan to submit, a
PMA application for the Allurion Balloon; the Allurion Balloon
being a novel therapy for people with obesity; and the ability of
the Allurion Balloon to fill the gap in the treatment of obesity
and serve as a valuable alternative to GLP-1 medications.
Forward-looking statements are predictions, projections and other
statements about future events that reflect the current beliefs and
assumptions of Allurion’s management based on information currently
available to them and, as a result, are subject to risks and
uncertainties. Many factors could cause actual future results or
developments to differ materially from the forward-looking
statements in this communication, including but not limited to (i)
the ability of Allurion to obtain and maintain regulatory approvals
for and successfully commercialize its program, including the
Allurion Balloon, its VCS platform, and its compounded GLP-1
program, in the United States and abroad, (ii) the timing of, and
results from, our clinical studies and trials and submission of
such results to regulatory authorities, including the PMA
application, (iii) the evolution of the markets in which Allurion
competes, including the impact of GLP-1s, (iv) the ability of
Allurion to defend its intellectual property, (v) the impact of the
COVID-19 pandemic, the Russia and Ukraine war, and the conflict in
the Middle East on Allurion’s business, (vi) Allurion’s
expectations regarding its market opportunities, including those
for the Allurion Program, its VCS platform, and its compounded
GLP-1 program, (vii) the risk of economic downturns and a changing
regulatory landscape in the highly competitive industry in which
Allurion operates, (viii) the successful development of our sales,
marketing and commercial capabilities in the U.S., if the Allurion
Balloon is approved by the FDA, (ix) our ability to raise capital
when needed, and (x) our ability to comply with NYSE listing
requirements. The foregoing list of factors is not exhaustive. You
should carefully consider the foregoing factors and the other risks
and uncertainties described in the “Risk Factors” section of
Allurion’s Annual Report on Form 10-K filed on March 26, 2024 (as
subsequently amended), Quarterly Report on Form 10-Q filed on
November 13, 2024, and other documents filed by Allurion from time
to time with the U.S. Securities and Exchange Commission. These
filings identify and address other important risks and
uncertainties that could cause actual events and results to differ
materially from those contained in the forward-looking statements.
Forward-looking statements speak only as of the date they are made.
Readers are cautioned not to put undue reliance on forward-looking
statements, and Allurion assumes no obligation and does not intend
to update or revise these forward-looking statements, whether as a
result of new information, future events, or otherwise. Allurion
does not give any assurance that it will achieve its
expectations.
_______________________ 1 Subjects received only the Allurion
Balloon without the Allurion App, Bluetooth® Scale, Coach Iris, or
access to the Virtual Care Suite. 2 The Allurion Balloon has not
been compared to other liquid-filled intragastric balloons in a
head-to-head study for weight loss or for frequency or type of
adverse events. 3 Ienca et al. Obesity Surgery. 2020
Sep;30(9):3354-3362. 4 Ienca R, et al. Sequential Elipse Balloon
Treatment 1 Year Weight Loss Results Approximate Bariatric Surgery
Results, 2020.
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version on businesswire.com: https://www.businesswire.com/news/home/20250107707450/en/
Global Media Hannah Lindberg hlindberg@allurion.com
Investor Contact Mike Cavanaugh, Investor Relations ICR
Westwicke (617) 877-9641 mike.cavanaugh@westwicke.com
Allurion Technologies (NYSE:ALUR)
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