Latest news with #HighTideTherapeutics
Yahoo
4 days ago
- Business
- Yahoo
HighTide Therapeutics And 2 Other Asian Penny Stocks To Watch Closely
Amidst a backdrop of fluctuating global trade policies and easing inflation, Asian markets have been navigating a complex economic landscape. For investors eyeing opportunities in smaller or newer companies, penny stocks—though an outdated term—still hold potential for growth at accessible price points. These stocks can offer notable value when backed by strong financials, making them intriguing options for those seeking hidden gems with promising long-term prospects. Name Share Price Market Cap Financial Health Rating Halcyon Technology (SET:HTECH) THB2.64 THB792M ★★★★★★ CNMC Goldmine Holdings (Catalist:5TP) SGD0.445 SGD180.35M ★★★★★☆ Beng Kuang Marine (SGX:BEZ) SGD0.176 SGD35.06M ★★★★★★ Yangzijiang Shipbuilding (Holdings) (SGX:BS6) SGD2.21 SGD8.7B ★★★★★☆ BRC Asia (SGX:BEC) SGD3.13 SGD858.72M ★★★★★★ Ever Sunshine Services Group (SEHK:1995) HK$1.90 HK$3.28B ★★★★★☆ Bosideng International Holdings (SEHK:3998) HK$4.39 HK$50.26B ★★★★★★ Lever Style (SEHK:1346) HK$1.15 HK$725.59M ★★★★★★ Goodbaby International Holdings (SEHK:1086) HK$1.20 HK$2B ★★★★★★ TK Group (Holdings) (SEHK:2283) HK$2.04 HK$1.7B ★★★★★★ Click here to see the full list of 1,161 stocks from our Asian Penny Stocks screener. Here we highlight a subset of our preferred stocks from the screener. Simply Wall St Financial Health Rating: ★★★★★☆ Overview: HighTide Therapeutics, Inc. is a biopharmaceutical company focused on discovering, researching, developing, and commercializing therapies for metabolic and digestive diseases in Mainland China, with a market cap of HK$1.42 billion. Operations: HighTide Therapeutics, Inc. has not reported any specific revenue segments at this time. Market Cap: HK$1.42B HighTide Therapeutics, Inc., a pre-revenue biopharmaceutical company, recently announced positive Phase 3 trial results for its lead compound HTD1801 in treating type 2 diabetes mellitus. Despite its lack of revenue and current unprofitability, the company has a strong financial position with short-term assets exceeding liabilities and more cash than debt. The management team is experienced, although the board is relatively new. HighTide's stock remains highly volatile, reflecting typical penny stock characteristics. The upcoming NDA submission for HTD1801 could be pivotal if approved by China's regulatory authorities later this year. Take a closer look at HighTide Therapeutics' potential here in our financial health report. Gain insights into HighTide Therapeutics' past trends and performance with our report on the company's historical track record. Simply Wall St Financial Health Rating: ★★★★☆☆ Overview: Shandong Molong Petroleum Machinery Company Limited, along with its subsidiaries, focuses on the design, research and development, production, and sale of energy equipment products and services both in China and internationally, with a market cap of HK$3.06 billion. Operations: No specific revenue segments are reported for Shandong Molong Petroleum Machinery Company Limited. Market Cap: HK$3.06B Shandong Molong Petroleum Machinery has shown a mix of financial challenges and operational resilience. Despite being unprofitable, the company maintains a positive cash runway for over three years, supported by CN¥2 billion in short-term assets exceeding its liabilities. However, its high net debt to equity ratio of 201.3% and increased debt levels highlight financial strain. The recent earnings report shows improved revenue but a significant drop in net income compared to the previous year, indicating volatility typical of penny stocks. Management's lack of experience could impact strategic decisions as they navigate these complexities. Unlock comprehensive insights into our analysis of Shandong Molong Petroleum Machinery stock in this financial health report. Assess Shandong Molong Petroleum Machinery's previous results with our detailed historical performance reports. Simply Wall St Financial Health Rating: ★★★★★★ Overview: Chongqing Lummy Pharmaceutical Co., Ltd. is involved in the research and development, manufacture, and sale of pharmaceutical products in China with a market cap of CN¥3.92 billion. Operations: The company's revenue is primarily generated from its operations in China, amounting to CN¥812.87 million. Market Cap: CN¥3.92B Chongqing Lummy Pharmaceutical faces financial challenges typical of penny stocks, with a net loss of CN¥13.78 million reported for Q1 2025 despite revenue growth to CN¥198.4 million. The company is unprofitable but has improved its debt profile, reducing the debt-to-equity ratio from 74.9% to 18.6% over five years and maintaining more cash than total debt, providing a stable cash runway exceeding three years even if free cash flow declines. Short-term assets of CN¥1.5 billion comfortably cover liabilities, though ongoing losses necessitate careful management by its experienced leadership team averaging over eight years in tenure. Click to explore a detailed breakdown of our findings in Chongqing Lummy Pharmaceutical's financial health report. Review our historical performance report to gain insights into Chongqing Lummy Pharmaceutical's track record. Click this link to deep-dive into the 1,161 companies within our Asian Penny Stocks screener. Looking For Alternative Opportunities? The end of cancer? These 23 emerging AI stocks are developing tech that will allow early idenification of life changing disesaes like cancer and Alzheimer's. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include SEHK:2511 SEHK:568 and SZSE:300006. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
4 days ago
- Business
- Yahoo
HighTide Therapeutics And 2 Other Asian Penny Stocks To Watch Closely
Amidst a backdrop of fluctuating global trade policies and easing inflation, Asian markets have been navigating a complex economic landscape. For investors eyeing opportunities in smaller or newer companies, penny stocks—though an outdated term—still hold potential for growth at accessible price points. These stocks can offer notable value when backed by strong financials, making them intriguing options for those seeking hidden gems with promising long-term prospects. Name Share Price Market Cap Financial Health Rating Halcyon Technology (SET:HTECH) THB2.64 THB792M ★★★★★★ CNMC Goldmine Holdings (Catalist:5TP) SGD0.445 SGD180.35M ★★★★★☆ Beng Kuang Marine (SGX:BEZ) SGD0.176 SGD35.06M ★★★★★★ Yangzijiang Shipbuilding (Holdings) (SGX:BS6) SGD2.21 SGD8.7B ★★★★★☆ BRC Asia (SGX:BEC) SGD3.13 SGD858.72M ★★★★★★ Ever Sunshine Services Group (SEHK:1995) HK$1.90 HK$3.28B ★★★★★☆ Bosideng International Holdings (SEHK:3998) HK$4.39 HK$50.26B ★★★★★★ Lever Style (SEHK:1346) HK$1.15 HK$725.59M ★★★★★★ Goodbaby International Holdings (SEHK:1086) HK$1.20 HK$2B ★★★★★★ TK Group (Holdings) (SEHK:2283) HK$2.04 HK$1.7B ★★★★★★ Click here to see the full list of 1,161 stocks from our Asian Penny Stocks screener. Here we highlight a subset of our preferred stocks from the screener. Simply Wall St Financial Health Rating: ★★★★★☆ Overview: HighTide Therapeutics, Inc. is a biopharmaceutical company focused on discovering, researching, developing, and commercializing therapies for metabolic and digestive diseases in Mainland China, with a market cap of HK$1.42 billion. Operations: HighTide Therapeutics, Inc. has not reported any specific revenue segments at this time. Market Cap: HK$1.42B HighTide Therapeutics, Inc., a pre-revenue biopharmaceutical company, recently announced positive Phase 3 trial results for its lead compound HTD1801 in treating type 2 diabetes mellitus. Despite its lack of revenue and current unprofitability, the company has a strong financial position with short-term assets exceeding liabilities and more cash than debt. The management team is experienced, although the board is relatively new. HighTide's stock remains highly volatile, reflecting typical penny stock characteristics. The upcoming NDA submission for HTD1801 could be pivotal if approved by China's regulatory authorities later this year. Take a closer look at HighTide Therapeutics' potential here in our financial health report. Gain insights into HighTide Therapeutics' past trends and performance with our report on the company's historical track record. Simply Wall St Financial Health Rating: ★★★★☆☆ Overview: Shandong Molong Petroleum Machinery Company Limited, along with its subsidiaries, focuses on the design, research and development, production, and sale of energy equipment products and services both in China and internationally, with a market cap of HK$3.06 billion. Operations: No specific revenue segments are reported for Shandong Molong Petroleum Machinery Company Limited. Market Cap: HK$3.06B Shandong Molong Petroleum Machinery has shown a mix of financial challenges and operational resilience. Despite being unprofitable, the company maintains a positive cash runway for over three years, supported by CN¥2 billion in short-term assets exceeding its liabilities. However, its high net debt to equity ratio of 201.3% and increased debt levels highlight financial strain. The recent earnings report shows improved revenue but a significant drop in net income compared to the previous year, indicating volatility typical of penny stocks. Management's lack of experience could impact strategic decisions as they navigate these complexities. Unlock comprehensive insights into our analysis of Shandong Molong Petroleum Machinery stock in this financial health report. Assess Shandong Molong Petroleum Machinery's previous results with our detailed historical performance reports. Simply Wall St Financial Health Rating: ★★★★★★ Overview: Chongqing Lummy Pharmaceutical Co., Ltd. is involved in the research and development, manufacture, and sale of pharmaceutical products in China with a market cap of CN¥3.92 billion. Operations: The company's revenue is primarily generated from its operations in China, amounting to CN¥812.87 million. Market Cap: CN¥3.92B Chongqing Lummy Pharmaceutical faces financial challenges typical of penny stocks, with a net loss of CN¥13.78 million reported for Q1 2025 despite revenue growth to CN¥198.4 million. The company is unprofitable but has improved its debt profile, reducing the debt-to-equity ratio from 74.9% to 18.6% over five years and maintaining more cash than total debt, providing a stable cash runway exceeding three years even if free cash flow declines. Short-term assets of CN¥1.5 billion comfortably cover liabilities, though ongoing losses necessitate careful management by its experienced leadership team averaging over eight years in tenure. Click to explore a detailed breakdown of our findings in Chongqing Lummy Pharmaceutical's financial health report. Review our historical performance report to gain insights into Chongqing Lummy Pharmaceutical's track record. Click this link to deep-dive into the 1,161 companies within our Asian Penny Stocks screener. Looking For Alternative Opportunities? The end of cancer? These 23 emerging AI stocks are developing tech that will allow early idenification of life changing disesaes like cancer and Alzheimer's. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include SEHK:2511 SEHK:568 and SZSE:300006. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@
Associated Press
26-04-2025
- Health
- Associated Press
HighTide Therapeutics to Showcase New Analyses of Phase 2 MASH/T2DM Studies of Berberine Ursodeoxycholate (HTD1801) and Pre-Clinical Results of Rimtoregtide (HTD4010) in Presentations at EASL Congress 2025
HONG KONG - April 25, 2025 ( NEWMEDIAWIRE ) – HighTide Therapeutics, Inc. ( a clinical stage biopharmaceutical company specializing in the development of multifunctional multi-targeted therapies for chronic liver and metabolic diseases, announced today that it will present at the EASL Congress 2025, taking place from May 7-10, 2025 in Amsterdam. The presentations include post-hoc analyses of two Phase 2 clinical studies of berberine ursodeoxycholate (HTD1801), a gut-liver anti-inflammatory metabolic modulator, being developed for treatment of metabolic dysfunction-associated steatohepatitis (MASH) and type 2 diabetes mellitus (T2DM). A third presentation will present preclinical results for rimtoregtide (HTD4010), a peptide derived from the Reg3a protein, in liver failure in mice. Effects of Berberine Ursodeoxycholate (HTD1801) in Patients with At-risk MASH and T2DM (Presentation SAT-440, Poster Presentation, May 10, 8:30 AM CET) About the Abstract: Due to the ongoing unmet medical need, clinical development in MASH focuses on patients who are at a higher risk of disease progression and outcomes due to the presence of moderate to advanced fibrosis (defined as at-risk MASH). The purpose of this analysis was to assess the effects of HTD1801 in patients with at-risk MASH and T2DM as defined by baseline MRI cT1>875 ms. Eighteen weeks of treatment with HTD1801 resulted in substantial improvements in key hepatic and cardiometabolic parameters in patients with at-risk MASH and compared to placebo, twice as many patients achieved a reduction in liver fat content (MRI-PDFF) or fibroinflammation (cT1) that have been associated with improvements in liver histology. These data are particularly insightful as HTD1801 continues to be evaluated in an ongoing paired biopsy study of patients with at-risk MASH and pre-diabetes or diabetes. Effects of Berberine Ursodeoxycholate (HTD1801) in Chinese Patients with T2DM and Presumed MASLD (Presentation SAT-432, Poster Presentation, May 10, 8:30 AM CET) About the Abstract: T2DM typically coexists with other metabolic abnormalities such as hyperlipidemia, obesity, and MASH that can exacerbate T2DM and can lead to a worse prognosis with increased risk for mortality and cardiovascular outcomes. In a Phase 2 study in patients with T2DM, HTD1801 achieved the primary endpoint with a significant decrease in HbA1c. Based on the latest diagnostic criteria, it is likely that a substantial subgroup of the study may have had concurrent metabolic dysfunction-associated steatotic liver disease (MASLD). The purpose of this analysis was to evaluate the benefits of HTD1801 in patients with T2DM and MASLD identified by baseline controlled attenuation parameter values >288 dB/M (correlated to 5% liver fat content). HTD1801 treatment demonstrated both dose-dependent improvements in cardiometabolic and hepatic parameters in patients with T2DM and MASLD. These data suggest HTD1801 can comprehensively address metabolic and cardiovascular risk factors beyond glycemic control. A Comparison of the Protective Effects of Rimtoregtide (HTD4010) and DUR-928 on Acute Liver Failure in Mice (Presentation FRI-141, Poster Presentation, May 9, 8:30 AM CET) About the Abstract: The purpose of this study was 1) to test the potential protective effects of HTD4010 in an LPS-induced model mimicking acute liver failure in mice and 2) compare these effects to DUR-928, which is currently in late-stage development for the treatment of alcohol-associated hepatitis. In an LPS-induced mouse model mimicking acute liver failure, HTD4010 resulted in significant improvement in survival rates (greater than 2-fold) compared to the model control. These protective effects of HTD4010 were significantly greater than DUR-928. These findings provide evidence that HTD4010 may have a beneficial effect on acute liver conditions including alcohol-associated hepatitis and other acute-inflammatory-related conditions. About Berberine Ursodeoxycholate Berberine ursodeoxycholate (HTD1801) is an orally delivered, gut-liver anti-inflammatory metabolic modulator being developed for the treatment of metabolic and digestive diseases. HTD1801, an ionic salt of berberine and ursodeoxycholate, is a new molecular entity with a unique dual mechanism of action: AMP kinase activation and NLRP3 inflammasome inhibition. These two key mechanistic pathways have been associated with improvements in insulin resistance, glucose metabolism, lipid metabolism, and hepatic inflammation, potentially providing a comprehensive treatment platform for the multifaceted nature of complex metabolic diseases. HTD1801 is being developed for multiple indications. HTD1801 met the primary endpoint in two Phase 3 clinical trials in patients with type 2 diabetes mellitus (T2DM), demonstrating a clinically meaningful effect on HbA1c. In both trials, key secondary endpoints were achieved, suggesting multiple advantages of HTD1801 including improvement in cardiometabolic risk indicators. In addition to T2DM, HTD1801 efficacy in treating metabolic dysfunction-associated steatohepatitis (MASH) has been demonstrated in a Phase 2a clinical trial, and a global multicenter Phase 2b trial assessing the histologic benefit of HTD1801 is currently ongoing, with topline results expected in 2025. About Rimtoregtide Rimtoregtide (HTD4010) is a clinical-stage compound in development for acute inflammatory-related indications including alcoholic hepatitis (AH). It is a peptide derived from the Reg3a protein with immunomodulatory, anti-inflammatory, and anti-apoptotic effects. HTD4010 has been evaluated in animal models of acute pancreatitis and acute liver failure, where protective effects were observed. A completed Phase 1 clinical trial of HTD4010 in healthy subjects demonstrated a favorable safety profile. AH is caused by chronic heavy alcohol abuse or a sudden, drastic increase in alcohol consumption. It is characterized by severe inflammation and, ultimately, liver failure and death. There is currently no approved treatment for AH and only a few drug candidates are in clinical development. The current standard of care focuses on symptom management, including abstinence, treating inflammation and providing nutrition. About HighTide Therapeutics HighTide Therapeutics, Inc. (Stock Code: is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional, multi-targeted therapies with poly-indication potential across metabolic diseases with significant unmet medical needs. HighTide is currently developing several clinical assets and associated global intellectual property rights, and advancing multiple mid-to-late-stage clinical trials including therapies for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes mellitus (T2DM), severe hypertriglyceridemia (SHTG) and primary sclerosing cholangitis (PSC). Berberine ursodeoxycholate (HTD1801), HighTide's lead drug candidate, received Fast Track designation from the United States Food and Drug Administration for both MASH and PSC and Orphan Drug designation for PSC. HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project in China. For more information, please visit Contact: [email protected]
Associated Press
15-04-2025
- Business
- Associated Press
Berberine Ursodeoxycholate (HTD1801) Consistently Demonstrates Comprehensive Benefits for Patients With Type 2 Diabetes Mellitus, Approaching NDA
HighTide Therapeutics Announces HTD1801 Meets the Primary Endpoints in Two Phase 3 Clinical Trials in Patients with Type 2 Diabetes Mellitus HONG KONG - April 15, 2025 ( NEWMEDIAWIRE ) - HighTide Therapeutics, Inc. ( a clinical-stage biopharmaceutical company specializing in the development of multifunctional, multi-targeted therapies for chronic liver and metabolic diseases, today announced that two Phase 3 trials (SYMPHONY 1 and SYMPHONY 2) of berberine ursodeoxycholate (HTD1801) in Chinese patients with type 2 diabetes mellitus (T2DM) met their primary endpoints and gated secondary endpoints. The results of these two Phase 3 clinical trials provide robust evidence that HTD1801 delivers comprehensive benefits for patients with T2DM. Based on these highly positive read-outs, 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 3 clinical trials designed to evaluate the efficacy and safety of HTD1801 in adults with T2DM and inadequate glycemic control despite using diet and exercise (SYMPHONY 1; N=407) or Metformin (SYMPHONY 2; N=549). The primary endpoint in both studies was the change in HbA1c from baseline with HTD1801 compared to placebo after 24 weeks of treatment. Gated secondary endpoints included the percentage of subjects achieving HbA1c <7.0%, change in fasting plasma glucose (FPG), low-density lipoprotein cholesterol (LDL-C), glutamyl transpeptidase (GGT), and high-sensitivity C-reactive protein (hs-CRP). The primary endpoint was achieved in both trials, showing a clinically meaningful, consistent glucose-lowering effect of HTD1801 SYMPHONY 1 (HTD1801 as monotherapy): At week 24, the reduction from baseline in HbA1c with HTD1801 (-1.3%) was superior to placebo. Further, those with more severe disease had a greater decrease with HTD1801: reduction in HbA1c was -1.5% for those with a baseline HbA1c ≥8.5%. 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. Further, those with more severe disease had a more significant decrease with HTD1801: reduction in HbA1c was -1.6% for those with a baseline HbA1c ≥8.5%. In both Phase 3 trials, the efficacy on HbA1c reduction in patients treated with HTD1801 was sustained through week 24. In both trials, gated secondary endpoints were achieved, suggesting multiple advantages of HTD1801 beyond glucose-lowering including improvement in cardiometabolic risk indicators At week 24, in both studies, the proportion of patients who achieved HbA1c <7.0% was significantly higher in the HTD1801 treatment groups compared to placebo. Improvements in HbA1c with HTD1801 were parallelled with significant improvements in postprandial and fasting plasma glucose compared with placebo. In addition, HTD1801 demonstrated lipid-lowering effects, including significant reductions in low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C). Moreover, HTD1801 treatment led to reductions in key inflammatory biomarkers - glutamyl transpeptidase (GGT) and high-sensitivity C-reactive protein (hs-CRP) - both of which are associated with cardiovascular risk in patients with T2DM. Favorable safety and tolerability profile Overall, safety and tolerability were favorable and consistent with previous clinical trials of HTD1801. The most commonly reported adverse events were gastrointestinal. In both studies <2% of patients discontinued early due to an adverse event. The incidence of hypoglycemia was low, with no severe hypoglycemia events reported. 'The encouraging results from these studies suggest that HTD1801 may offer a novel and improved therapeutic option for patients with T2DM,' said Dr. Linong Ji, the leading principal investigator for the two Phase 3 clinical trials 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. 'As an innovative drug candidate, HTD1801 exhibits a unique dual mechanism of action - AMP kinase activation and NLRP3 inflammasome inhibition - that is distinct from any existing T2DM drugs on the market. It is an oral therapy designed to deliver comprehensive clinical benefits - not only lowering blood glucose but also improving lipid metabolism and exerting anti-inflammatory effects - thereby potentially reducing diabetes-related complications and addressing significant unmet clinical needs. With continued clinical exploration, HTD1801 is expected to further expand its application to benefit patients globally. In today's pharmaceutical landscape, investment has become heavily concentrated on GLP-1-based drug development. While GLP-1 therapies hold significant clinical value, they do not adequately address the full spectrum of pathophysiological mechanisms underlying T2DM. To truly meet the multifaceted needs of T2DM management, continued innovation across a diverse range of therapeutic targets remains essential.' 'We extend our deepest gratitude to the patients who participated in these pivotal trials,' said Dr. Liping Liu, HighTide's founder and CEO. 'HTD1801's innovative dual-action approach – targeting both metabolic regulation and inhibiting inflammation – represents a potential breakthrough in diabetes treatment. We look forward to sharing data from the 28-week open-label extension of these studies and a Phase 3 head-to-head comparison with the dapagliflozin; we will continue to explore the clinical potential of HTD1801 to provide patients with chronic metabolic diseases a comprehensive treatment solution.' About Type 2 Diabetes Mellitus (T2DM) According to the International Diabetes Federation (IDF), 537 million adults (ages 20-79) were living with diabetes in 2021, and this number is projected to grow to 783 million (representing 1 in 8 adults) by 2045, of these, around 90% are T2DM cases. China has the largest population of diabetes patients worldwide, estimated to be 141 million in 2021, and projected to grow to 174 million in 2045. 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 Berberine Ursodeoxycholate (HTD1801) Berberine ursodeoxycholate (HTD1801) is an orally delivered, gut-liver anti-inflammatory metabolic modulator being developed for the treatment of metabolic and digestive diseases. HTD1801, an ionic salt of berberine and ursodeoxycholate, is a new molecular entity with a unique dual mechanism of action: AMP kinase activation and NLRP3 inflammasome inhibition. These two key mechanistic pathways have been associated with improvements in insulin resistance, glucose metabolism, lipid metabolism, and hepatic inflammation, potentially providing a comprehensive treatment platform for the multifaceted nature of complex metabolic diseases. HTD1801 is being developed for multiple indications. In addition to T2DM, its efficacy in treating metabolic dysfunction-associated steatohepatitis (MASH) has been demonstrated in a Phase 2a clinical trial and a global multicenter Phase 2b trial assessing the histologic benefit of HTD1801 is currently ongoing, with topline results expected in 2025. About HighTide Therapeutics HighTide Therapeutics, Inc. (Stock Code: is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional, multi-targeted therapies with poly-indication potential across chronic liver and metabolic diseases with significant unmet medical needs. HighTide is currently developing several clinical assets and associated global intellectual property rights, and advancing multiple mid-to-late-stage clinical trials including therapies for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes mellitus (T2DM), severe hypertriglyceridemia (SHTG) and primary sclerosing cholangitis (PSC). Berberine ursodeoxycholate (HTD1801), HighTide's lead drug candidate, received Fast Track designation from the United States Food and Drug Administration for both MASH and PSC and Orphan Drug designation for PSC. HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project in China. For more information, please visit Contact: [email protected] View the original release on
Associated Press
05-03-2025
- Health
- Associated Press
HighTide Therapeutics Announces Publication of Phase 2 Study of Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes Mellitus in JAMA Network Open
ROCKVILLE, MD and SHENZHEN - March 4, 2025 ( NEWMEDIAWIRE) - HighTide Therapeutics, Inc. ( a clinical stage biopharmaceutical company specializing in the development of multifunctional multi-targeted therapies for chronic liver and metabolic diseases, today announced that data from the Phase 2 proof-of-concept study evaluating berberine ursodeoxycholate (HTD1801) for the treatment of type 2 diabetes mellitus (T2DM) was published online in JAMA Network Open. The publication reports results of the randomized, placebo-controlled 12-week study to assess efficacy, safety and tolerability of HTD1801 compared to placebo in patients with T2DM. The trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in HbA1c at week 12 with HTD1801 versus placebo. A majority of patients treated with HTD1801 achieved target HbA1c <7%. Further, results show therapeutic benefit of HTD1801 on LDL and total cholesterol, markers of liver injury and systemic inflammation. In this study, HTD1801 was well tolerated with no treatment-related serious adverse events observed. These findings are being confirmed in ongoing Phase 3 studies. 'We are encouraged by the results of this Phase 2 study. The study provides evidence that HTD1801 can treat the core aspects of metabolic syndrome, with potential to provide a spectrum of therapeutic effects that appear to address comorbid conditions that exacerbate disease and worsen prognosis of patients with T2DM,' said Dr. Linong Ji, Professor of Medicine at Peking University, Director of Peking University Diabetes Center and Director of the Department of Endocrinology and Metabolism, Peking University People's Hospital, in Beijing, China. 'Based on these positive findings, we are continuing to advance the clinical development of HTD1801 in our ongoing Phase 3 T2DM program with topline results expected in the first half of this year,' said Dr. Liping Liu, CEO of HighTide Therapeutics. About JAMA Network Open Journal JAMA Network Open is an international, peer-reviewed, open access, general medical journal that publishes research on clinical care, innovation in health care, health policy, and global health across all health disciplines and countries for clinicians, investigators, and policy makers. JAMA Network Open is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications. About Berberine Ursodeoxycholate (HTD1801) Berberine ursodeoxycholate (HTD1801) is an orally delivered, gut-liver anti-inflammatory metabolic modulator being developed for the treatment of metabolic and digestive diseases. HTD1801, an ionic salt of berberine and ursodeoxycholate, is a new molecular entity with unique dual mechanisms of action, including AMP kinase activation and NLRP3 inflammasome inhibition. These two key mechanistic pathways have been associated with improvements in glucose metabolism, insulin resistance, lipid metabolism, and hepatic inflammation, potentially providing a comprehensive treatment platform for the multifaceted nature of complex metabolic diseases such as T2DM. About HighTide Therapeutics HighTide Therapeutics, Inc. (Stock Code: is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional multi-targeted therapies with poly-indication potential across multiple metabolic and digestive diseases with significant unmet medical needs. The Company is currently developing several clinical assets and holding global intellectual property rights, advancing multiple mid-to-late-stage clinical trials including therapy for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes mellitus (T2DM), severe hypertriglyceridemia (SHTG) and primary sclerosing cholangitis (PSC). Berberine ursodeoxycholate (HTD1801), the Company's lead drug candidate, received Fast Track designation from the United States Food and Drug Administration for both MASH and PSC and Orphan Drug designation for PSC. HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project in China.
