Lixisenatide

Semaglutide, the active ingredient in Novo Nordisk's Wegovy®, is a GLP-1 receptor agonist that works by binding to and activating the GLP-1 receptor, thereby exerting its effects in the treatment of obesity. Given that the GLP-1 receptor is involved in the specific brain regions that regulate appetite, the application of Wegovy® in obese patients can significantly reduce hunger, enhance satiety, and decrease food cravings, thereby assisting patients in reducing caloric intake and achieving weight loss. Moreover, through genetic engineering, Wegovy® has been successful in extending its half-life to 7 days, allowing for a once-weekly dosing regimen, providing Chinese patients with a safe and convenient weight management solution.   Zhangkezhou, the Corporate Vice President of Pharmaceutical Quality at Novo Nordisk Greater China, stated that Novo Nordisk's research in the field of obesity treatment has spanned over 25 years, and the company has established a solid scientific foundation based on GLP-1RA therapy. The company is committed to comprehensively addressing the overall health of obese patients and aims to provide them with an integrated treatment plan. Looking ahead, Novo Nordisk will continue to lead the innovative breakthroughs in the field of obesity treatment to meet the diverse medical needs of Chinese patients.   Zhou Xiaping, the Global Senior Vice President and President of Novo Nordisk Greater China, emphasizes that as a global leader in the field of obesity treatment, Novo Nordisk is dedicated to changing the world's perception, prevention, and treatment of obesity. Coinciding with Novo Nordisk China's 30th anniversary, Wegovy® as the company's latest innovative drug introduced to China will effectively address the unmet medical needs in the field of obesity treatment in China. The company is grateful for the support and guidance from the National Medical Products Administration and relevant government departments in accelerating the introduction of innovative drugs to China, as well as the contributions of researchers and participants in the clinical trials.   Novo Nordisk will uphold its mission of "driving change and working together to overcome serious chronic diseases" and focus on patient-centricity, accelerating innovation, and diversifying and comprehensively contributing to the prevention and treatment of chronic diseases in China, supporting the "Healthy China 2030" initiative.   It is hereby declared that the approved Wegovy® (for long-term weight management in adults) and the already marketed Ozempic® (for the treatment of type 2 diabetes in adults) are both prescription drugs, targeting different diseases and cannot be substituted for each other. About Wegovy® (semaglutide injection for long-term weight management) Wegovy® is the world's first and currently the only once-weekly GLP-1RA for long-term weight management, providing not only significant weight loss but also multiple health benefits. Wegovy® has been launched in over 10 countries and regions globally. Wegovy® is indicated for long-term weight management in adults with an initial body mass index (BMI) of: - BMI ≥ 30 kg/m² (obesity) - BMI 27 kg/m² to < 30 kg/m² (overweight) with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease.   Wegovy® can achieve an average weight loss of 17% (16.8 kg) and provide multiple health benefits, including reduced waist circumference, decreased visceral fat, improved lipid profile, and delayed progression to type 2 diabetes. In the global STEP clinical trial series covering over 25,000 overweight and obese participants, as well as real-world data studies, Wegovy® has demonstrated good safety and tolerability. Its active ingredient, semaglutide, has up to 94% structural homology with human GLP-1 and has been extensively validated for its safety, used by 5.4 million patients globally. The most common adverse reactions of Wegovy® are mild to moderate transient gastrointestinal events.   About the STEP Clinical Trial Series The STEP clinical trial series for Wegovy® (semaglutide injection for long-term weight management) started in June 2018 and has completed 14 trials to date, including 12 global Phase 3 trials, 1 regional Phase 3 trial in East Asia, and 1 regional Phase 3 trial primarily in China. These trials have study durations of 11-24 months, with an average maximum treatment period of 34 months, aiming to evaluate the efficacy, safety, and other health benefits of Wegovy® in the long-term weight management of adults. Overall, the STEP clinical trial data have shown that Wegovy® can significantly reduce the weight of adult overweight and obese patients across different regions, ethnicities, ages, and genders, with or without type 2 diabetes, with an average weight loss of 17% (16.8 kg), and has demonstrated good safety and tolerability.

Oversubscribed financing led by strategic investor, with participation from new and existing investors MINNEAPOLIS, June 25, 2024 /PRNewswire/ -- Endogenex, a clinical-stage medical device company dedicated to improving outcomes in individuals with type 2 diabetes, announced it has closed an oversubscribed Series C financing totaling $88 million. The new capital will be used to complete the pivotal ReCET Clinical Study, which has been granted an Investigational Device Exemption (IDE) by the U.S. Food and Drug Administration (FDA). A group of new investors, including Hatteras Venture Partners, Lumira Ventures, and Orlando Health Ventures, joined an undisclosed strategic lead investor and existing investors Intuitive Ventures, Longitude Capital, Mayo Clinic, and Santé Ventures in the Series C funding. "We are excited to take this significant step forward in our mission to transform diabetes care," said Stacey Pugh, CEO of Endogenex. "This funding will enable us to complete our pivotal clinical study, bringing us closer to offering a groundbreaking solution for type 2 diabetes patients. The therapeutic landscape in diabetes continues to evolve, especially around the earlier use of SGLT2i and GLP-1RA. However, there remains a considerable unmet need to address the underlying pathophysiology and progression of the disease." "We are very proud of the company's progress, and this successful funding round is a testament to Endogenex's innovative technology," said Juliet Tammenoms Bakker, Endogenex Board Chair and Managing Director at Longitude Capital. "This milestone underscores our investors' confidence in the company's vision and the impact it can make in treating the epidemic of type 2 diabetes around the world." About the ReCET Clinical Study The ReCET Clinical Study is a multicenter, prospective, randomized, double-blinded, sham-controlled study assessing the safety and effectiveness of the ReCET System. The pivotal study received IDE approval in November 2023. The study will enroll up to 350 patients at clinical sites in the United States and Australia. About the ReCET™ Procedure ReCET is a novel, endoscopic outpatient procedure that targets the cellular pathology of the duodenum. This pathology may contribute to the development and progression of type 2 diabetes. The ReCET System aims to initiate the body's natural regenerative process by applying highly controlled, non-thermal pulsed electric fields to the mucosa and sub-mucosa duodenal tissue. This approach may help restore proper cellular signaling from the duodenum and improve metabolic function, including better control of blood glucose levels. The ReCET System has been evaluated in feasibility clinical studies, such as REGENT-1 US, REGENT-1 Australia, and EMINENT in the Netherlands. These studies assessed the safety and efficacy of the treatment in adults with type 2 diabetes whose blood glucose levels were inadequately controlled despite using insulin and non-insulin medications. Preliminary outcomes from these studies have been presented at medical conferences globally. The ReCET System has received an FDA Breakthrough Device Designation for treating type 2 diabetes in adults inadequately controlled by glucose-lowering medications. About Endogenex™ Endogenex, founded in partnership with Mayo Clinic, aims to revolutionize treatment options for individuals with type 2 diabetes (T2D). The company's innovations focus on resetting the body's metabolic signaling system by harnessing its natural regenerative capabilities to improve metabolic function. Through the development of the ReCET System and the novel application of precise, controlled, non-thermal pulsed electric fields, Endogenex is establishing a new era in T2D therapy, helping patients regain control of their blood glucose levels and slow disease progression. For more information, please visit . Media Inquiries: Brent Collins bcollins@endogenex.com +1(612) 227-6949