Category: Healthcare

HONG KONG, Oct 9, 2025 – (ACN Newswire) – Everest Medicines today announced that the results of its Asian multicenter Phase III ENLIGHT UC study (ES101002) of etrasimod (VELSIPITY(R)) for the treatment of subjects with moderately to severely active ulcerative colitis (UC) have been published in the prestigious international journal The Lancet Gastroenterology & Hepatology, marking the global recognition of this next-generation selective S1P receptor modulator’s efficacy in Asian patients.

The published results are from the ENLIGHT UC study (ES101002), a multicenter, randomized, double-blind, placebo-controlled Phase III trial of etrasimod conducted across Asia. ENLIGHT is the largest completed Phase III trial to date in Asian patients with moderately to severely active UC, enrolling 340 eligible subjects who were randomized to receive once-daily etrasimod or placebo for 12 weeks of induction treatment. All patients had an inadequate response or intolerance to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy.

The study results showed that, during both the 12-week induction phase and the 40-week maintenance phase, etrasimod demonstrated statistically significant and clinically meaningful improvements across all primary and secondary efficacy endpoints. The safety profile of etrasimod was consistent with previous studies, with no new safety signals observed.

Prof. Wu Kaichun at the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod’s Asia clinical trial said: “As the largest Phase III trial of UC in Asia, the results fill the gap in clinical data on active UC in Asia. The results confirm that etrasimod shows good efficacy and safety in Asian patients including Chinese patients, with positive effects on improving clinical symptoms and promoting endoscopic improvement.”

“Publication of the ENLIGHT UC study in The Lancet Gastroenterology & Hepatology underscores etrasimod’s strong clinical value in the treatment of moderately to severely active UC and providing stronger clinical evidence to support patients across Asia.” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines.“The company initiated local production of etrasimod in March and remains committed to accelerating the regulatory approval process in Mainland China and other Asian markets, helping more patients achieve higher-quality, longer-lasting disease remission.”

VELSIPITY(R) has been approved in Singapore, Macao SAR, and Hong Kong SAR. Its NDA has also been accepted in South Korea and Taiwan, China. In December 2024, China’s National Medical Products Administration (NMPA) officially accepted the NDA for VELSIPITY(R), with approval expected in the first half of 2026. As Everest’s third commercialized product, VELSIPITY(R) has been approved by the Guangdong Provincial Medical Products Administration for adult patients with moderately to severely active UC, and is now available at medical institutions designated under the Connect Policy in the Greater Bay Area. The localized production project for VELSIPITY(R) was officially launched at the Jiashan manufacturing site in March 2025, providing strong support for its future commercialization.

As a core product of Everest Medicines, etrasimod is an innovative and advanced therapy that provides rapid onset of action, clinical remission and endoscopic improvement through an oral, once-daily regimen. Following its inclusion in the American Gastroenterological Association (AGA) Clinical Practice Guideline as a first-line treatment for ulcerative colitis in December 2024, etrasimod was included in the American College of Gastroenterology (ACG) Clinical Guideline Update in June 2025, strongly recommended for both induction and maintenance of remission in patients with moderately to severely active UC.

From the market perspective, the number of UC patients in Asia is rising rapidly, while treatment options remain relatively limited. In China alone, the UC patient population was estimated at approximately 800,000 in 2024 and is projected to reach 1.5 million by 2031. With its proven efficacy and safety, VELSIPITY(R) is expected to quickly enter and reshape the market landscape. To ensure accessibility and supply stability, Everest has launched a localized production project at its Jiashan manufacturing site, with an expected annual production capacity of up to 50 million tablets to enhance supply stability and cost efficiency.

Notably, in late August Everest launched a proactive build-up of its commercial team for etrasimod, with the team expected to expand significantly around the time of approval. This deployment will not only ensure the efficient commercialization of VELSIPITY(R) upon launch, but also lay a solid foundation for future inclusion in the National Reimbursement Drug List (NRDL) and large-scale uptake.

Industry observers widely expect VELSIPITY(R) to become Everest’s next blockbuster product, with analysts projecting peak sales of up to RMB 5 billion. As VELSIPITY(R) realizes its commercial potential, Everest’s revenue mix and growth trajectory are expected to strengthen further, providing greater visibility and confidence for long-term investors.

– These 52-week data reinforce HTD1801’s potential as a truly differentiated therapeutic to concurrently address metabolic dysregulation, inflammation, and renal progression in type 2 diabetes mellitus

HONG KONG, Oct 31, 2025 – (ACN Newswire) – HighTide Therapeutics, Inc. (2511.HK), a biopharmaceutical company specializing in the development of multifunctional, multi-targeted therapies for chronic metabolic diseases, announced positive 52-week safety and efficacy results from the open-label extension (OLE) phases of two Phase III trials (SYMPHONY-1 and SYMPHONY-2) evaluating HTD1801 in patients with type 2 diabetes mellitus (T2DM).

The 52-week data from these two Phase III clinical trials demonstrate the durability of response and highlight the comprehensive long-term clinical benefits of HTD1801 in patients with T2DM. HighTide plans to submit a new drug application (NDA) for HTD1801 as a treatment for T2DM to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) later this year.

SYMPHONY-1 (NCT06350890) and SYMPHONY-2 (NCT06353347) are randomized, double-blind, placebo-controlled, Phase III clinical trials designed to evaluate the efficacy and safety of HTD1801 in adults with T2DM and inadequate glycemic control despite diet and exercise (SYMPHONY-1; N=408) or with Metformin (SYMPHONY-2; N=551). The primary endpoint in both studies was the change in glycated hemoglobin (HbA1c) from baseline with HTD1801 compared to placebo after 24 weeks of treatment. Patients were eligible to continue in a 28-week OLE during which all patients received HTD1801; Durability of response across efficacy endpoints was evaluated based on the change from baseline to Week 52.

Efficacy observed during the 24-week double-blind period was durable and maintained with longer-term treatment through 52 weeks in both studies

SYMPHONY-1 (HTD1801 as monotherapy): At week 24, the reduction from baseline in HbA1c with HTD1801 (-1.3%) was superior to placebo. HbA1c reductions were maintained in patients who continued receiving HTD1801 (-1.2% at Week 52). Placebo patients who switched to HTD1801 saw a reduction in HbA1c of -1.3% at Week 52, substantiating the double-blind phase findings.

SYMPHONY-2 (HTD1801 as an add-on therapy to Metformin): At week 24, the reduction from baseline in HbA1c with HTD1801 (-1.2%) was superior to placebo. HbA1c reductions were sustained in patients who continued receiving HTD1801 (-1.1% at Week 52). Placebo patients who switched to HTD1801 saw a reduction in HbA1c of -1.2% at Week 52, also substantiating the double-blind phase findings.

In both studies, the durability of effect on other cardiometabolic and renal endpoints was maintained at 52 weeks, suggesting comprehensive advantages of HTD1801 beyond glycemic control with long-term treatment.

In both studies, the proportion of patients receiving HTD1801 during the double-blind phase who achieved target HbA1c<7.0% was sustained through Week 52. The lipid-lowering effects observed during the double-blind phase, including significant reductions in low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C), were also maintained. Long-term HTD1801 treatment also led to continued reductions in key inflammatory biomarkers, including gamma-glutamyl transferase (GGT) and high-sensitivity C-reactive protein (hs-CRP), both associated with cardiovascular risk in patients with T2DM.

Notably, while estimated glomerular filtration rate (eGFR) remained stable in the overall population, the improvement of eGFR in patients with mild renal impairment at Week 24 was preserved at Week 52. These data highlighting the potential renal benefit of HTD1801 will be presented at a forthcoming scientific meeting.

Favorable safety and tolerability profile

Overall, long-term safety and tolerability were favorable and consistent with the double-blind phase. The types and severity of AEs did not increase with continued HTD1801 treatment compared to newly initiated HTD1801 treatment.

“The robust 52-week results from these trials reinforce that HTD1801 may represent a novel and truly differentiated therapeutic option for patients with T2DM,” said Dr. Linong Ji, Lead Principal Investigator, former Vice President of the International Diabetes Federation (IDF), and Director of the Peking University Diabetes Center and the Department of Endocrinology and Metabolism at Peking University People’s Hospital. “As a first-in-class new molecular entity, HTD1801 is an anti-inflammatory metabolic modulator (AIMM) with a dual mechanism of action, AMP kinase activation and NLRP3 inflammasome inhibition, distinct from existing therapies. Its unique profile is designed not only to lower blood glucose, but also to improve lipid metabolism, exert anti-inflammatory effects, and potentially enhance renal function, supporting its potential as a backbone therapy to address the cardiovascular-kidney-metabolic (CKM) syndrome by targeting the underlying drivers of diabetes and diabetes-related complications. In addition, the unique mechanism allows for potential of combination treatments”

“We extend our deepest gratitude to the patients who participated in these pivotal studies,” said Dr. Liping Liu, Founder, Chairperson, and CEO of HighTide Therapeutics. “Given the progressive nature of T2DM, durability of effect is a key determinant of long-term therapeutic success. The sustained beneficial effects of HTD1801 on metabolic, inflammatory, and renal parameters help reduce the risk of both microvascular and macrovascular complications. We look forward to sharing results from our Phase III head-to-head study with dapagliflozin, and will continue to explore HTD1801’s potential to deliver patients with chronic metabolic diseases a truly comprehensive, long-term treatment solution.”

About Type 2 Diabetes Mellitus (T2DM)

According to the International Diabetes Federation (IDF), 589 million adults (ages 20-79) were living with diabetes in 2024, and this number is projected to grow to 853 million (representing 1 in 8 adults) by 2050, of these, around 90% are T2DM cases. China has the largest population of diabetes patients worldwide, estimated to be 148 million in 2024, and projected to grow to 168 million in 2050. Diabetes is a global societal burden leading to over 6 million deaths per year. To address this urgent challenge, there is a critical need for innovative therapies that can deliver comprehensive clinical benefits for patients worldwide.

About HTD1801

HTD1801 is a first-in-class new molecular entity that targets the residual risks underlying cardiovascular–kidney–metabolic (CKM) diseases. It is an orally delivered, anti-inflammatory metabolic modulator (AIMM) that, as a single molecule, exerts a unique dual mechanism of action through activation of AMP Kinase and inhibition of the NLRP3 inflammasome, two complementary pathways that mitigate metabolic dysfunction. Multiple global clinical studies have demonstrated the comprehensive benefits of HTD1801, including improved insulin sensitivity, glycemic control, lipid lowering, renal protection, weight reduction, hepatic improvement, and anti-inflammatory effects. Collectively, these findings support the potential of HTD1801 to serve as a foundation therapy in CKM disease management.

HONG KONG, Sep 17, 2025 – (ACN Newswire) – 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 Metformin
Presentation Number: 62
Presentation Date/Time: Tuesday September 16, 2025 / 2:45pm CEST
Format: Oral Presentation
Presenting 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 HTD1801

HTD1801 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 Therapeutics

HighTide 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