Endogenex reports results on ReCET system for type 2 diabetes management
Endogenex, a company focused on developing medical devices for type 2 diabetes management, has shared results from its REGENT-1 clinical study during the Digestive Disease Week (DDW) 2025 event held in San Diego, US.
The study evaluated the safety and feasibility of the Endogenex pulsed electric field system (ReCET system) in the US and Australia.
The system is an investigational endoscopic outpatient procedure that employs non-thermal energy to address inflamed and dysfunctional tissue linked to type 2 diabetic duodenopathy.
This treatment aims to regenerate healthy cells in the mucosal and sub-mucosal layers of the duodenum, which plays a crucial role in metabolic processes.
Endogenex CEO Stacey Pugh said: 'The REGENT-1 study continues to deliver promising results, reinforcing the ReCET System's potential as a transformative treatment for type 2 diabetes.
'We have known for some time that the duodenum plays an important role in type 2 diabetes, and these new data– along with other cutting-edge analyses being presented here at DDW – illuminate and reinforce the duodenum as a novel target in the treatment of type 2 diabetes.'
The findings from the REGENT-1 Australia study indicated notable enhancements in insulin sensitivity and beta cell function at 12 weeks.
Improvements sustained at 48 weeks in a dose-responsive manner, indicating the 'durability' of the treatment, according to the company.
The study reported a procedural success rate of 100%, with no serious adverse events related to the device or the procedure, according to the company
REGENT-1 study lead author Dr Barham Abu Dayyeh said: 'These findings reinforce that the duodenal mucosa and submucosa are critical therapeutic targets for advancing type 2 diabetes treatment and disease management.
'These results lay the groundwork for further studies, and we are eager to expand the clinical evidence base.'
In June 2024, Endogenex closed an oversubscribed Series C financing round, securing $88m to complete the ReCET clinical study.
"Endogenex reports results on ReCET system for type 2 diabetes management" was originally created and published by Medical Device Network, a GlobalData owned brand.
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Business Journals
41 minutes ago
- Business Journals
The GLP-1 weight loss debate: Pharmacy benefit leaders weigh in on difficult coverage decisions
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Employee benefit strategies for employers Employers are left with difficult choices. Harclerode recommends business leaders start by assessing how GLP-1s fit the needs of their employees. Ask these questions: What is the prevalence of obesity and related conditions within my population? What can we expect in terms of utilization? How much would that utilization cost? Does that cost fit within our employee benefits budget? What is my employee turnover rate? Given that, will our plan realize the potential future benefits that come with weight loss? How important is offering this coverage to our talent attraction and retention efforts? Employers that decide to offer GLP-1 coverage should make sure to design their program in a way that maximizes its effectiveness, Harclerode said. Some clients require people to participate in wellness programs — such as working with a health coach or dietitian — to be eligible for GLP-1 therapies. 'Since these drugs require long-term use for sustained benefits, we want to ensure that if a member stops their GLP-1 therapy, the appropriate behavioral changes have been adopted to maintain the weight loss that was achieved while on the medication,' she said. Because of their popularity, businesses that opt not to cover GLP-1s may want to be transparent with employees about why and what they're doing to support weight loss instead, Harclerode said. They won't be alone. In a 2024 Business Group on Health survey, 67% of large employers reported covering GLP-1s, while only 28% of Holmes Murphy's clients — including many businesses with less than 10,000 people — provide the coverage. 'I don't think there's a one-size-fits-all approach,' Harclerode said. Are you getting the most out of your employer-sponsored pharmacy benefits? From pricing terms and contracts to understanding clinical programs, Holmes Murphy can help. As one of the largest independent insurance brokerages in the nation, Holmes Murphy believes fully in serving the unique risk and benefits challenges of clients in every industry and of almost every size. For more information, visit or follow the company on X (@holmesmurphyins), Facebook, LinkedIn, or Instagram.


Indianapolis Star
2 hours ago
- Indianapolis Star
Protagonist Announces Nomination of PN-477, an Oral and Injectable GLP-1R, GIPR, and GCGR Triple Agonist Peptide Development Candidate for Obesity
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The triple agonist PN-477 is designed to offer the optimal combination of total body weight loss, improved gastrointestinal (GI) tolerability and fat to lean mass ratio, with the dosing convenience of a once-daily oral agent and the added optionality of a once-weekly subcutaneous administration. 'We are very pleased to nominate development candidate PN-477, a promising potential best-in class oral GLP-1, GIP, GCG receptor tri-agonist peptide which has demonstrated optimal absolute and relative activity against all three hormone receptors in preclinical testing,' said Dinesh V. Patel, PhD, President and CEO of Protagonist. 'PN-477 is specifically engineered to be orally stable with attention to the relative balance of potencies against the three receptors to potentially leverage their beneficial effects on weight loss and optimal body composition while mitigating their adverse effects. As with our previous drug candidates and late-stage assets, PN-477 is a testament to the power of our peptide technology platform, including the ability to deliver first- and best-in-class targeted oral and injectable peptide therapeutics.' PN-477 has completed extensive preclinical evaluation including oral and metabolic stability, potency, pharmacokinetics and pharmacodynamics studies, and has demonstrated effects in preclinical models of obesity and glycemic control. PN-477 has shown potent in vitro activity in activating the GLP-1, GIP, and GCG receptors. PN-477 also demonstrated robust preclinical proof-of-concept in various animal studies including the diet induced obesity (DIO) preclinical mouse model, normal dogs, and cynomolgus monkeys. Overall, PN-477 has the right balance of potency, oral and in-vivo stability, and pharmacokinetic properties to enable parallel development both as a once-daily oral (PN-477o) and once-weekly injectable (PN-477sc) treatment options. 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More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of PN-477, and the timing of PN-477 clinical development. In some cases, you can identify these statements by forward-looking words such as 'anticipate,' 'believe,' 'may,' 'will,' 'expect,' or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading 'Risk Factors' contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release. Investor Relations Contact Corey Davis, Ph.D. LifeSci Advisors cdavis@ +1 212 915 2577 Media Relations Contact Virginia Amann ENTENTE Network of Companies virginiaamann@ +1 833 500 0061 ext. 1 SOURCE: Protagonist Therapeutics View the original press release on ACCESS Newswire


USA Today
9 hours ago
- USA Today
Protagonist Announces Nomination of PN-477, an Oral and Injectable GLP-1R, GIPR, and GCGR Triple Agonist Peptide Development Candidate for Obesity
A novel oral peptide PN-477o with once-daily dosing, high potency and activation of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic peptide (GIP), and glucagon (GCG) receptors Company will also develop a subcutaneous version, PN-477sc, as a once-weekly injection IND-enabling studies underway, with Phase I study initiation expected in 2Q26 Webcast and conference call to be held today at 4:30 pm ET Protagonist Therapeutics, Inc. ('Protagonist' or the 'Company') today announced the selection of PN-477, a potential best-in-class GLP-1, GIP, GCG receptor triple agonist peptide with oral and subcutaneous routes of administration, as a development candidate for the treatment of obesity. The triple agonist PN-477 is designed to offer the optimal combination of total body weight loss, improved gastrointestinal (GI) tolerability and fat to lean mass ratio, with the dosing convenience of a once-daily oral agent and the added optionality of a once-weekly subcutaneous administration. 'We are very pleased to nominate development candidate PN-477, a promising potential best-in class oral GLP-1, GIP, GCG receptor tri-agonist peptide which has demonstrated optimal absolute and relative activity against all three hormone receptors in preclinical testing,' said Dinesh V. Patel, PhD, President and CEO of Protagonist. 'PN-477 is specifically engineered to be orally stable with attention to the relative balance of potencies against the three receptors to potentially leverage their beneficial effects on weight loss and optimal body composition while mitigating their adverse effects. As with our previous drug candidates and late-stage assets, PN-477 is a testament to the power of our peptide technology platform, including the ability to deliver first- and best-in-class targeted oral and injectable peptide therapeutics.' PN-477 has completed extensive preclinical evaluation including oral and metabolic stability, potency, pharmacokinetics and pharmacodynamics studies, and has demonstrated effects in preclinical models of obesity and glycemic control. PN-477 has shown potent in vitro activity in activating the GLP-1, GIP, and GCG receptors. PN-477 also demonstrated robust preclinical proof-of-concept in various animal studies including the diet induced obesity (DIO) preclinical mouse model, normal dogs, and cynomolgus monkeys. Overall, PN-477 has the right balance of potency, oral and in-vivo stability, and pharmacokinetic properties to enable parallel development both as a once-daily oral (PN-477o) and once-weekly injectable (PN-477sc) treatment options. IND enabling studies of PN-477 are underway and initiation of Phase 1 clinical studies is anticipated in the second quarter of 2026. 'While GLP-1 agonists have dominated the market thus far, there remains a broad opportunity for novel therapeutics with better body weight loss, higher ratio of fat to lean mass loss, tolerability and additional beneficial effects in obesity-related comorbidities. A triple GLP-1, GIP, GCG receptor agonist peptide that offers weight loss on par with the best injectable treatments options, as well as the optionality provided by both oral and injectable routes of administration, would be an important therapeutic breakthrough and represents another potential blockbuster drug opportunity for Protagonist,' added Dr. Patel. 'We look forward to moving PN-477 into first-in human clinical Phase 1 studies in the second quarter of 2026.' Conference Call and Webcast Details The dial-in numbers for Protagonist's investor update on Monday, June 30th at 4:30 pm ET are: US-based Investors: 1-877-407-0752 International Investors: 1-201-389-0912 Conference Call ID: 13754335 The webcast link for the event can be found here: A replay of the presentation will be available on the Company's Investor Relations Events and Presentations webpage following the event. About Protagonist Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA potentially in 2025. Icotrokinra (formerly, JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ('IL-23R') which is licensed to J&J Innovative Medicines ('JNJ'), formerly Janssen Biotech, Inc. Following icotrokinra's joint discovery by Protagonist and JNJ scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with JNJ assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage drug discovery programs addressing clinically and commercially validated targets, including IL-17 oral peptide antagonist PN-881, obesity triple agonist peptide PN-477, and oral hepcidin. More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of PN-477, and the timing of PN-477 clinical development. In some cases, you can identify these statements by forward-looking words such as 'anticipate,' 'believe,' 'may,' 'will,' 'expect,' or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading 'Risk Factors' contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release. Investor Relations Contact Corey Davis, Ph.D. LifeSci Advisors cdavis@ +1 212 915 2577 Media Relations Contact Virginia Amann ENTENTE Network of Companies virginiaamann@ +1 833 500 0061 ext. 1 SOURCE: Protagonist Therapeutics View the original press release on ACCESS Newswire