Weight and cardiometabolic effects of a novel oral shape-shifting superabsorbent hydrogel capsule: Prespecified and exploratory analysis of the Epitomee capsule RESET study

Article

作者: Ganon-Elazar, E ; Ryan, D H ; Kamar, M ; Kushner, R F ; Greenway, F L ; Jakicic, J M ; Ard, J D ; Wyatt, H R ; Bays, H E ; O'Neil, P M ; Asaraf, L Cohen ; Wadden, T A

BackgroundManagement of obesity potentially improves cardiometabolic risk factors in patients with metabolic syndrome (MetS). The Epitomee capsule is a non-pharmacological, biodegradable device treatment for weight reduction in patients with overweight and obesity.MethodsThis secondary analysis of the Randomized Evaluation of Safety and Efficacy of the Epitomee capsule Trial (RESET) (a randomized, 24-week, multicenter, placebo-controlled, double-blind trial that enrolled 279 adults aged ≥18 years with a BMI of 27-40 kg/m2) evaluated changes in cardiometabolic parameters in participants treated with Epitomee or placebo combined with lifestyle counseling among (a) the entire RESET study population, and (b) participants meeting diagnostic criteria for prediabetes. Predefined and exploratory endpoints included changes in waist circumference, glycemic parameters, blood pressure, and lipid blood levels; this analysis also assessed percent weight loss in participants with MetS.ResultsWaist circumference, systolic and diastolic blood pressure and some measures of glycemia and lipids, improved with both Epitomee and placebo with no significant differences. Participants with prediabetes treated with Epitomee showed significantly greater reductions in HOMA-IR (p < 0.007) and insulin levels (p < 0.003) than the placebo group. Participants with MetS at baseline experienced significantly greater percent change in initial weight when treated with the Epitomee capsule (n = 27) compared to placebo (n = 31), -8.3% vs -5.2 %, respectively (p < 0.0004). Similar percentages of participants with MetS in both groups achieved ≥5 % weight reduction (59.3 % and 54.8 %, in Epitomee and placebo groups respectively). Significantly more participants with MetS treated with Epitomee achieved ≥10 % weight reduction compared with those treated with placebo (40.7 % vs. 6.5 %, respectively, p < 0.002).ConclusionTreatment with either Epitomee and placebo combined with lifestyle improve cardiometabolic risk factors. Compared to placebo, Epitomee significantly reduced HOMA-IR and insulin levels in participants with prediabetes. Among participants with MetS, Epitomee significantly reduced body weight [ClinicalTrials.gov ID NCT04222322].

项与 Epitomee Medical Ltd. 相关的新闻（医药）

2024-11-19

·PRNewswire

Epitomee's Drug-Free Capsule Helps Patients Shed Pounds: RESET Study Results presented at ObesityWeek® 2024

CAESAREA, Israel, Nov. 19, 2024 /PRNewswire/ -- Epitomee Medical Ltd. (TASE: EPIT) announces that significant results from its RESET study on a novel oral hydrogel capsule for weight loss were presented at ObesityWeek® 2024. The prestigious event, organized by The Obesity Society (TOS), took place from November 2-6, 2024, in San Antonio, Texas. The oral presentation, delivered by Professor Jamy D. Ard MD of Wake Forest University School of Medicine, highlighted the results of a randomized, double-blind, placebo-controlled study assessing the safety and efficacy of the Epitomee® Capsule. Professor Ard, an esteemed leader in obesity research and President of The Obesity Society, emphasized the potential impact of this innovative, drug-free capsule for weight loss. The Epitomee capsule works by expanding into a triangular shape in the stomach, enhancing satiety, reducing appetite and calorie intake through a non-pharmacological mechanism. Results of the RESET Study: Patients were randomized to Epitomee (n=138) or placebo (n=141). The study demonstrated that both co-primary endpoints were successfully met. The RESET study demonstrated significantly better weight loss among the device group compared to the control group (P<0.0001). The co-primary endpoint of treatment responders was also achieved: the rate of Epitomee treatment group subjects whose total body weight was reduced by at least 5% at 24-weeks post randomization was 55.5% (CI; 46.1-64.6), significantly exceeding the threshold of >35% (P<0.0001). ~60% of the Epitomee group were found to be early responders, identified as those losing at least 2% of body weight at week 8 achieving an average of ~10% weight loss at week 24. Significant reductions of change from baseline in HOMA-IR (p<0.007) and in insulin levels (p<0.003) which were seen in Epitomee-treated patients with prediabetes versus placebo. Epitomee treatment significantly improved all QOL domains and Total scores in comparison to baseline and significantly outperforms the placebo in improving Total QOL and Physical Function Scores. There were no serious adverse device effects (SADEs) in the study and no difference between groups in overall and in gastrointestinal-related AEs. Donna H. Ryan MD, Professor Emerita at Pennington Biomedical Research Center, shared her perspective on Epitomee capsule: "Epitomee offers a very safe approach that patients can use when they need help with appetite control – it's taken before meals. Epitomee is not absorbed – it acts in the stomach and thus, it has none of the side effects that we expect with the GLP-1 meds. Patients can eat healthy meals of real food and still lose weight by feeling fuller sooner. Epitomee is a good addition to our treatment toolbox – the safety, tolerability and efficacy profile make it a good fit for many patient types and for both weight loss and to aid in weight loss maintenance. We see a significant advantage in using Epitomee for individuals starting at a BMI of 25, a category where most anti-obesity medications are still not approved, regardless of whether additional health complications are present." Reflecting on the study's success, Professor Jamy Ard stated, "Epitomee capsule is a safe and effective, non-pharmacological option for weight management with broad application in patients with overweight or obesity. Because the Epitomee treatment was found to be safe and well-tolerated, it can be used for a wide variety of patients, even those who might not tolerate other medications or have contraindications for those medications" About The Obesity Society (TOS): As the world leading professional organization focused on obesity science and treatment, TOS's annual ObesityWeek® conference brings together experts to discuss advancements in obesity care, including clinical applications, research, and policy initiatives. About Epitomee Medical Ltd.: Epitomee Medical Ltd. is a pioneering technology based health solutions company, committed to advancing innovative therapies. The company is advancing two major fields: weight management and biologic drug delivery. In addition to its flagship weight management solution, Epitomee Medical is developing a cutting-edge platform focused on the oral delivery of biologics. This innovative platform is designed to transport drugs to the absorption site with enhanced bioavailability. For partnership inquiries and more information about the weight-management capsule, please contact: Mr. Alon Heth VP Sales and Marketing [email protected] For more information about Epitomee Medical Ltd., please visit Epitomee Medical at: Logo - SOURCE Epitomee Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果

2024-10-15

·PRNewswire

Epitomee Medical to Present the Epitomee Breakthrough Oral Delivery Platform at PODD 2024 Conference

CAESAREA, Israel, Oct. 15, 2024 /PRNewswire/ -- Epitomee Medical Ltd. (TASE: EPIT) announces today that the company leadership intends to present Epitomee's Oral Delivery of Biologics Platform at the 14th Annual PODD Conference - Partnership Opportunities in Drug Delivery, taking place in Boston, MA, October 28-29, 2024. Presentation Title: "Breakthrough Device for Oral Delivery of Biologics". Date & Time: October 22, 2024, 2:30 PM – 2:45 PM Presenter: Dr. Gil Cohen, PhD, VP R&D Epitomee Medical will present its Breakthrough Oral Delivery Platform at PODD 2024 in Boston on October 29. Dr. Gil Cohen, VP R&D, will highlight innovations in biologics delivery, offering a non-invasive alternative to injections. Visit epitomeemedical.com.

2024-09-18

·美通社

Epitomee Medical宣布其胶囊式体重管理设备获FDA批准

Epitomee的可吞咽胶囊为BMI在25-40之间、希望在节食和运动之外寻找非药物体重管理方式的成年人提供了一种安全有效的处方解决方案。以色列凯撒利亚 2024年9月18日 /美通社/ -- Epitomee Medical Ltd. （特拉维夫证券交易所：EPIT）宣布，其Epitomee®胶囊已正式获得美国食品药品监督管理局（FDA）的批准。这是一种尖端的可吞咽医疗设备，旨在帮助BMI在25-40 kg/m²的成年人进行体重管理，使用者仍需配合饮食和运动。这种新颖的无药物治疗为数百万注重健康的美国居民提供了全新选择。用于体重管理的Epitomee®胶囊获FDA批准！ Epitomee®胶囊已正式获得FDA批准，这是一种突破性的口服处方设备，旨在帮助BMI在25-40 kg/m²之间的超重和肥胖成年人进行体重管理，使用者仍需配合饮食和运动。这种创新的无药物解决方案通过增加饱腹感，助力人们实现更健康的生活方式。 Epitomee®胶囊提供了一种创新的处方选择，在一众体重管理方式中脱颖而出，它作为无药物替代方案，有别于注射治疗。 FDA批准Epitomee®胶囊适用于BMI在25及以上的成年人，这为更广泛的患者群体提供了可能，他们期望找到更易于耐受且便于使用的体重管理方式。 Epitomee®设备封装在标准尺寸的自行可吞咽胶囊中。当Epitomee®胶囊被患者吞下并到达胃部后，会吸收胃部的水分并形成三维基质，占据胃部空间，产生饱腹感，从而帮助患者减肥。 Epitomee®胶囊的作用机制是纯机械性的，不涉及任何化学活性。胶囊直接作用于胃肠道（GI）内。 Epitomee®胶囊在RESET研究后获得美国FDA批准：该研究是一项前瞻性、随机、双盲、并进行了安慰剂对照的多中心试验。该研究招募了279名超重和肥胖的成人参与者，部分伴有前期糖尿病。参与研究的9个试验点均位于美国9个不同州。符合条件的受试者被随机分配到测试组或安慰剂组。受试者每天服用两次试验设备胶囊或安慰剂，并配合饮食和运动，持续24周。研究显示，两项共同的主要目标均已达成。 RESET研究表明，与对照组相比，设备组受试者的减重效果更加显著（P<0.0001）。治疗响应者的共同主要目标也已达成：在随机分配24周后，Epitomee治疗组中体重减少至少5%的受试者比例为55.5%（置信区间：46.1-64.6），明显高于>35%的阈值（P<0.0001）。研究还表明，在整个研究期间，Epitomee®疗法具有良好的安全性。 Epitomee®治疗组的患者耐受性良好，退出研究的患者人数少于对照组。研究中未发现严重的不良设备反应（SADE）。此外，接受Epitomee®治疗的受试者在IWQOL-Lite-CT问卷的多个项目中都显示生活质量得到了更好的改善。公司还在参与RESET研究的9个试验点中的3个进行了额外ELECT研究。在这项研究中，设备组和安慰剂组的受试者再继续服用24周的Epitomee®胶囊。研究显示，在48周的研究期间，Epitomee®治疗设备组受试者的安全性良好。公司联合创始人兼董事会主席Shimon Eckhouse博士就获得FDA批准发表评论：“FDA对Epitomee®胶囊的批准标志着体重管理领域的一个重要里程碑。其创新方法为患者提供了安全有效的选择。通过这种简单、无药物的胶囊来管理体重，这种疗法为那些寻求改善健康和生活质量的人们提供了新的可能性。” Epitomee Medical Ltd.的CEO Dan Hashimshony博士也表示：“我们为Epitomee®的无药物口服体重管理方式获得FDA批准感到自豪。这是我们采取创新方法应对全球肥胖问题的成果。我们的胶囊为数以百万计、面临体重管理挑战的人们提供了一种安全、有效且无药物的解决方案。展望未来，我们期待将这一突破性产品引入美国市场，并寻求战略合作伙伴，以充分实现其商业潜力。” 关于Epitomee Medical Ltd. Epitomee Medical Ltd.（特拉维夫证券交易所：EPIT）是一家成立于2005年的上市公司，由Shimon Eckhouse博士联合创立，并由CEO Dan Hashimshony博士领导。 Shimon还联合创立了Syneron Medical Ltd. （纳斯达克股票代码：ELOS）、Lumenis（前身为ESC Medical）和Ventor Medical Technologies（被Medtronic收购）。 Dan曾是Dune Medical Devices（一家外科肿瘤学公司，后被Dilon Technologies收购）的创始CEO。此前，Dan还曾在X-Technologies（2003年被Guidant收购）和Sela Semiconductor（被Camtek收购）任职。该公司是一家开创性的健康解决方案公司，致力于推进创新疗法。 Epitomee Medical专注于安全性、有效性和生活质量的提升，力争走在变革性医疗解决方案的前沿。公司正致力于推动两个主要领域的发展：体重管理和生物药物给药。除了其旗舰体重管理解决方案外，Epitomee Medical还在开发一个尖端平台，专注于生物药物的口服给药。该创新平台旨在将药物输送至吸收部位，提高生物利用度。如需了解有关Epitomee Medical Ltd.的更多信息，请访问 Epitomee Medical（ https:\/\/epitomeemedical.com\/）如需合作咨询以及关于体重管理胶囊的更多信息，请联系： Mr. Alon Heth 销售与营销副总裁 alon@epitomeemedical.com