วัน: 17 กันยายน 2025

HONG KONG, Sep 17, 2025 - (ACN Newswire via SeaPRwire.com) – HighTide Therapeutics, Inc. (2511.HK), a clinical stage biopharmaceutical company specializing in the development of multifunctional multi-targeted therapies for metabolic diseases, announced that data from the Phase 3 SYMPHONY 2 trial evaluating the safety and efficacy of HTD1801 in patients with type 2 diabetes mellitus (T2DM) is being presented at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna.HTD1801, is a first-in-class anti-inflammatory metabolic modulator that activates AMPK and inhibits the NLRP3 inflammasome. These pathways converge at the nexus of metabolic dysregulation beyond glucose control and chronic inflammation. This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of HTD1801 compared to placebo in patients with T2DM inadequately controlled with metformin. The primary endpoint of Symphony 2 was change from baseline in HbA1c to Week 24 compared to placebo. Secondary endpoints explored effects on cardiovascular, metabolic, and renal comorbidities to assess it’s potential as a comprehensive Cardiovascular-Kidney-Metabolic therapy.Eligible patients were randomized 2:1 to HTD1801 1000 mg BID (N=365) or placebo (N=184). The study met the primary endpoint at Week 24, with HTD1801-treated patients achieving an LS mean change in HbA1c of -1.21% compared to -0.68% with placebo (LS mean diff: -0.53, p<0.0001). 33% of HTD1801-treated patients achieved HbA1c <7% at Week 24 vs 11% with placebo (p<0.0001). Improvements in HbA1c with HTD1801 were parallelled with significant improvements in postprandial and fasting glucose at Week 24. In patients with mild renal impairment, HTD1801 improved eGFR, suggesting reno-protective potential. Significant reductions in lipids and inflammatory markers were also observed with HTD1801. Safety and tolerability were favorable and consistent with previous clinical trials of HTD1801. Serious AEs occurred in 4% vs 6% of patients with HTD1801 vs placebo, respectively. No patient experienced severe hypoglycemia during the study. An open-label extension is ongoing to confirm the durability of these benefits of HTD1801.Abstract Title: Symphony 2: A Randomized, Placebo-Controlled Phase 3 Study of Berberine Ursodeoxycholate in Patients with Type 2 Diabetes Inadequately Controlled with MetforminPresentation Number: 62Presentation Date/Time: Tuesday September 16, 2025 / 2:45pm CESTFormat: Oral PresentationPresenting Author: Linong Ji“HTD1801 is an innovative small-molecule drug with a novel dual mechanism of action, simultaneously activating AMPK and inhibiting the NLRP3 inflammasome.”said professor Linong Ji, the leading principal investigator for this Phase 3 clinical trial and former Vice President of the International Diabetes Federation (IDF), Director of the Peking University Diabetes Center and Director of the Department of Endocrinology and Metabolism, Peking University People’s Hospital, “In completed Phase 3 clinical trials, it demonstrated consistent and clinically meaningful glucose-lowering effects with a favorable safety profile. Beyond glycemic control, HTD1801 has also shown multiple additional benefits, including lipid reduction, attenuation of inflammation, and improvements in renal function. As an orally administered antidiabetic agent, HTD1801 uniquely provides both cardiometabolic risk factor modification and renal protection, underscoring its substantial potential and competitive advantage for further clinical development.”“The SYMPHONY 2 trial is our second Phase 3 study in type 2 diabetes to achieve its primary endpoint, underscoring the consistency and robustness of HTD1801’s clinical profile,” said Liping Liu, Founder, Chairwoman and CEO of HighTide Therapeutics. “We are particularly pleased that HTD1801 demonstrated not only glycemic benefit but potential cardiovascular and renal benefit in T2DM patients. With successful Phase 3 trials now in hand, we are well-positioned to submit our NDA in China later this year – marking a major step toward bringing a novel therapy to millions of patients who continue to face significant unmet needs in diabetes care.”About HTD1801HTD1801 is a first-in-class new molecular entity, addressing the residual risks of cardiovascular-kidney-metabolic (CKM) diseases. HTD1801 is an orally delivered, anti-inflammatory metabolic modulator that, as a single molecular entity, exhibits a unique dual mechanism of action through AMPK activation and NLRP3 inflammasome inhibition, both pathways working to mitigate dysfunctions associated with metabolic diseases. Multiple global clinical trial results have demonstrated comprehensive benefits of HTD1801, including improved insulin resistance, glycemic control, lipid lowering, renal benefit, weight loss, hepatic benefits, and anti-inflammatory effects. Therefore, HTD1801 has the potential to become a foundational CKM therapy.About HighTide TherapeuticsHighTide Therapeutics, Inc. (2511.HK) is an innovative biopharmaceutical company specializing in metabolic diseases. The company is dedicated to developing first-in-class breakthrough therapies, providing therapeutic solutions with comprehensive benefits for patients worldwide. HighTide Therapeutics has established a globally positioned product pipeline with 100% self-developed intellectual property. The company has conducted clinical studies for multiple indications across various countries and regions, and the outcomes of these studies have been well recognized by global academic community and regulatory bodies worldwide. HTD1801, HighTide Therapeutics’ lead asset, is a first-in-class dual-target new molecular entity. It has received two Fast Track designations and one Orphan Drug designation from the US Food and Drug Administration (FDA), and has been included twice in the National Major Science and Technology Project for Significant New Drug Development in China.For more information, please visit www.hightidetx.com, Contact: pr@hightidetx.com Copyright 2025 ACN Newswire via SeaPRwire.com. All rights reserved. www.acnnewswire.com

PHILADELPHIA, PA, Sept 17, 2025 - (ACN Newswire via SeaPRwire.com) - TruMerit, a global leader in healthcare workforce development, today launched two new global credentials for healthcare workers specializing in rehabilitation, habilitation, and restorative care.The Certified Global Health Worker-Rehabilitation (CGHW-R) and the Certified Global Health Worker-Rehabilitation Advanced (CGHW-RA) have been developed specifically for eligible health workers worldwide who wish to have their applied experience and competencies in rehab care recognized and verified by passing a certification examination. These credentials, along with the Certified Global Nurse-Rehabilitation (CGN-R) that TruMerit established last year, are intended to advance and improve services for the more than two billion people worldwide who need this care.The CGHW-RA credential was developed for those with a degree or diploma in a rehabilitation field. These include clinicians, educators, and instructors with physiotherapy, occupational therapy, speech language pathology, or other rehab-related specializations.The CGHW-R credential was designed for those who have rehab health experience but have not completed post-secondary education in an area of rehab specialization. These would include technicians, assistive personnel, nursing assistants, and home or community health aides working in rehabilitation, habilitation, and restorative care settings.In addition to education and degree requirements, candidates for these credentials must have at least two years of work experience in a rehabilitation, habilitation, or restorative care setting during the last five years. Upon verification of their credentials by TruMerit, they must pass a proctored exam that is offered at more than 1,000 test centers worldwide.In 2019, CARF International, a non-profit organization that accredits rehabilitation care providers worldwide, alerted TruMerit (known then as CGFNS International) about the growing demand for validating practice competence of the rehabilitation health workforce and raising standards across the care continuum. TruMerit and rehabilitation experts from across the world began the process to create exam-based global certifications for healthcare professionals working in rehabilitation, habilitation, and restorative care settings. The process has included more than 200 subject matter experts from 45 countries from all world regions and income levels."Caring for the huge and growing population of persons living with a disability is one of the most pressing issues facing healthcare today. By validating the knowledge and skills of those who devote their careers to providing this care, global credentials will help drive efforts to expand and equip this vital workforce to meet the challenges of the future. We are grateful to the global team of rehab care experts who helped make these credentials possible," said Julia To Dutka, Chief of TruMerit's Global Health Workforce Development Institute, which is leading the initiative.View more information on TruMerit's global rehab certification program.Additionally, last month TruMerit unveiled its Certified Global Nurse (CGN) credential for first-level, general nurses (RNs), along with a reinvented Nurse Qualifying Exam.About TruMeritTruMerit is a worldwide leader in healthcare workforce development. Formerly known as CGFNS International, the organization has a nearly 50-year history supporting the career mobility of nurses and other healthcare workers-and those who license and hire them-by validating their education, skills, and experience as they seek authorization to practice in the United States and other countries. As TruMerit, this mission has been expanded to building workforce capacity that meets the needs of people in a rapidly evolving global health landscape. Through its Global Health Workforce Development Institute, the organization is advancing evidence-based research, thought leadership, and advocacy in support of healthcare workforce development solutions, including globally recognized practice standards and certifications that will enhance career pathways for healthcare workers.Contact InformationDavid St. Johndstjohn@trumerit.orgSOURCE: TruMerit Copyright 2025 ACN Newswire via SeaPRwire.com. All rights reserved. www.acnnewswire.com