Trial Results Demonstrate ESG Procedure Offers Significant and Durable Weight Loss, with Improvements in Obesity-Related Health Conditions
- MERIT-Trial met its primary endpoints for safety and efficacy, with patients undergoing the Endoscopic Sleeve Gastroplasty (ESG) procedure achieving excess body weight loss of 49.2% at 12 months and a serious adverse event rate of 2%
- Patients undergoing ESG also had clinically significant reductions in diabetes, hypertension and metabolic syndrome at 12 months
AUSTIN, TX / ACCESSWIRE / October 22, 2021 / Apollo Endosurgery, Inc. ("Apollo") (NASDAQ:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, today announced that study investigators of the Multi-Center ESG Randomized Interventional Trial (MERIT) presented positive outcomes.
Dr. Barham Abu Dayyeh, Professor of Medicine and Director of Advanced Endoscopy at the Mayo Clinic, presented the data at the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) during the "Top 10 Papers at IFSO" session.
Key highlights include:
- Study Methods: The trial enrolled 208 patients across nine US centers. Patients were randomized between ESG and moderate lifestyle modification controls. Average BMI at enrollment was 35.7 ±2.6 kg/m2. The primary efficacy endpoint was Percent Excess Weight Loss (%EWL) and responders were defined as those achieving at least 25% EWL at 12 months. The study targeted a serious adverse event rate of <5%, which was the primary safety endpoint. Patients were followed for 24 months, with control subjects given the option to cross over at 12 months.
- Efficacy: Patients undergoing Endoscopic Sleeve Gastroplasty (ESG) demonstrated an excess body weight loss (EWL) of 49.2% (+32%) at 12 months, which was a 45% difference in %EWL compared to patients undergoing moderate intensity lifestyle modification. Furthermore, 77% of subjects undergoing ESG achieved at least 25% EWL, and percent total body weight loss (%TBWL) for this responder group was 16.3% (+7%).
- Impact on Co-Morbidities: Patients undergoing ESG demonstrated improvements in diabetes, hypertension, and metabolic syndrome compared to controls, as well as improvement in, and no onset of, gastroesophageal reflux disease (GERD).
- Safety: ESG met the primary safety endpoint with a rate of serious adverse events of 2.0% (3/150), all of which resolved and did not require intensive care or surgical intervention[i].
- Durability: Despite the Global Pandemic during year-two, cross-over patients achieved similar results to the initial treatment group and those that had undergone treatment maintained the vast majority of their weight loss at 24 months.
"The MERIT outcomes are compelling, and the medical community is eager to embrace new treatment options to address the global obesity problem," said Dr. Abu Dayyeh. "Endoscopic Sleeve Gastroplasty offers a scalable, safe, effective, organ-sparing solution that can be performed in an outpatient facility by either a gastroenterologist or a bariatric surgeon. In addition, the ESG procedure can be combined with other therapeutic options to further enhance patient outcomes."
ESG is a minimally-invasive (nonsurgical) weight loss procedure that uses the OverStitch™ Endoscopic Suturing System to reduce the volume of a person's stomach. The MERIT data adds to a larger body of evidence for ESG of more than 200 publications and abstracts reporting positive outcomes in over 6,500 patients[ii].
Worldwide obesity has nearly tripled since 1975, with more than 650 million people now considered obese[iii]. In the U.S., more than 100 million adults are obese, greater than 40 percent of the adult population[iv]. Obesity related conditions including heart disease, stroke, type 2 diabetes, and certain types of cancer are among the leading causes of preventable, premature death. Obesity costs the U.S. health care system more than $170 billion a year[v]. Yet, less than one percent of obese patients are treated with bariatric surgical weight loss procedures each year.
"This is a significant milestone for Apollo in our mission to dramatically impact chronic obesity and obesity-related health conditions that continue unabated around the world," said Chas McKhann, president and CEO of Apollo Endosurgery. "The results of MERIT support that the ESG procedure offers a compelling value proposition of clinically significant weight loss from a safe, convenient, outpatient procedure. We look forward to our continued work with the FDA, following our recent De Novo 510(k) submission, as we seek regulatory clearance to recognize ESG as a potential treatment option for those living with obesity."
About the MERIT Study
The MERIT study (NCT03406975, FDA IDE G190189) is a multi-center, prospective randomized clinical trial evaluating the safety and effectiveness of the ESG procedure, a minimally invasive, endoscopic weight loss procedure performed with Apollo Endosurgery's OverStitch® Endoscopic Suturing System compared to a medically monitored regimen of diet and healthy lifestyle. The co-principal investigators are Dr. Erik Wilson, University of Texas at Houston (Houston, TX), and Dr. Barham Abu Dayyeh, Mayo Clinic, (Rochester, MN) under a collaborative research agreement sponsored by Apollo Endosurgery. The study's primary efficacy endpoint is to achieve at least 25% excess body weight loss (%EBWL) at 12 months and at least 15% EWL vs. control at 12 months, and the primary safety endpoint is a serious adverse event rate of less than 5%. Serious adverse events were those that scored a ‘3' or more using the Clavien-Dindo classification. Additionally, patients undergoing ESG are being evaluated for improvement in hypertension and type 2 diabetes at 24 months.
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical technology company focused on development of next-generation, minimally invasive devices to advance therapeutic endoscopy designed to treat a variety of gastrointestinal conditions including closure of gastrointestinal defects, managing gastrointestinal complications, and the treatment of obesity. Apollo's device-based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo's products are offered in over 75 countries today and include the X-Tack® Endoscopic HeliX Tacking System, the OverStitch® Endoscopic Suturing System, the OverStitch Sx® Endoscopic Suturing System, and the ORBERA® Intragastric Balloon.
Legal Notice Regarding Forward-Looking Statements
Certain statements in this press release are forward-looking statements that are subject to risks and uncertainties that could cause results to be materially different than expectations, including Apollo's expectations regarding the final publication of the MERIT-Trial data supporting the presentation and Apollo's utilization of the MERIT-Trial results in a submission to the FDA to potentially add a new indication for ESG. Important factors that could cause actual results to differ materially include: further analysis and full publication of the MERIT-Trial data may result in additional information, conclusions or characterization of the achievement of trial objective and endpoints; the impact of the ongoing COVID-19 pandemic and the effect it may have on Apollo's operations, the demand for the Apollo's products, Apollo's liquidity position, global supply chains and economic activity in general; reports of adverse events related to our products, outcomes of clinical studies related to our products; development of competitive products or procedures; regulatory approvals and extensive regulatory oversight by the FDA or other regulatory authorities; unfavorable media coverage related to our products or related procedures; coverage and reimbursement decisions by private or government payors; Apollo's ability to support the adoption of its products and broaden its product portfolio; the potential size of Apollo's addressable markets; the execution of our gross margin improvement projects; the availability of cash for Apollo's future operations as well as other factors detailed in Apollo's periodic reports filed with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2020 and its Form 10-Q for the period ending June 30, 2021. Copies of reports filed with the SEC are posted on Apollo's website and are available from Apollo without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Apollo disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.
[i] There were three serious adverse events (2%): a peri-gastric abscess, bleeding, and malnutrition. All were treated successfully by endoscopy without need for intensive care or formal surgery. In addition, while most patients received the ESG as an outpatient procedure, six patients (4%) were briefly hospitalized for non-serious adverse events to manage their difficulties with accommodation of reduced gastric volume.
[ii] Apollo Endosurgery internal meta-analysis of published ESG studies
[iii] World Health Organization (June 2021)
[iv] Centers for Disease Control and Prevention (February 2020)