English | 简体中文 | 繁體中文 | 한국어 | 日本語
Thursday, 17 November 2022, 08:00 HKT/SGT
Share:
    

Source: HighTide Therapeutics Inc.
AJG Publishes Data from HighTide Therapeutics' Phase 2 Study of HTD1801 Treatment in Primary Sclerosing Cholangitis

ROCKVILLE, MD and SHENZHEN, CHINA, Nov 17, 2022 - (ACN Newswire) - HighTide Therapeutics, Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the publication of the results of their Phase 2 study of HTD1801 in adults with primary sclerosing cholangitis (PSC) in the American Journal of Gastroenterology. (https://journals.lww.com/ajg/Fulltext/2022/11000/A_Randomized,_Dose_Finding,_Proof_of_Concept_Study.22.aspx)

This study met the primary endpoint and multiple key secondary endpoints, demonstrating the safety and efficacy of HTD1801 in treating PSC. Serum alkaline phosphatase (ALP) is a key biomarker of PSC disease severity. Data show that compared to placebo, both low and high doses of HTD1801 treatment could significantly reduce serum ALP levels. In addition, HTD1801 significantly reduced alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT), further supporting the beneficial effects of HTD1801 in treating PSC. HTD1801 was shown to be safe and well tolerated at the doses studied in PSC patients. No severe adverse event related to HTD1801 treatment occurred.

Professor Kris Kowdley, M.D., Director, Liver Institute Northwest and lead investigator, said, "There is a significant unmet medical need in treatment for PSC. The improvements in ALP we observed in this study, along with the excellent safety profile of HTD1801, are promising. In addition, the results of this study lay the foundation for future studies that will potentially prove the significant role of HTD1801 in the treatment of PSC."

Dr. Liping Liu, Founder and Chief Executive Officer of HighTide Therapeutics, said, "We are pleased to share the news of this publication. The results of this study encourage us to further study HTD1801's effects in treating PSC. We believe the long-term treatment of HTD1801 will lead to more clinical benefits for patients with PSC, who suffer with a disease with no effective therapy until today."

About Primary Sclerosing Cholangitis

Primary sclerosing cholangitis (PSC) is a chronic, progressive liver disease characterized by progressive inflammation and fibrosis of the intra-and/or extra-hepatic bile ducts, resulting in multifocal bile duct strictures. Most patients eventually have liver failure and cirrhosis, and their risk of malignancy significantly increases. PSC is strongly associated with inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. The accumulating evidence from various studies continues to strengthen the hypothesis that the gut microbiota plays a central role in the pathogenesis and progression of PSC. Until today, there is no approved therapy for PSC. As the fifth leading indication for liver transplantation in the U.S., PSC is a disease with significant unmet medical needs.

About HighTide Therapeutics

HighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of novel multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company's lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). HTD1801 has received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program. For more information, please visit www.hightidetx.com.

Contact
Jeffrey Dao
ir@hightidetx.com
+1-650-580-3872

Topic: Clinical Trial Results
Source: HighTide Therapeutics Inc.

Sectors: Healthcare & Pharm, Clinical Trials
https://www.acnnewswire.com
From the Asia Corporate News Network


Copyright © 2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.

 

HighTide Therapeutics Inc. Related News
June 5, 2024 09:00 HKT/SGT
君圣泰医药将在2024年国际肝病大会发布MASH临床2a期研究分析结果,进一步展现熊去氧胆小檗碱(HTD1801)的疗效与安全性
June 5, 2024 09:00 HKT/SGT
君聖泰醫藥將在2024年國際肝病大會發布MASH臨床2a期研究分析結果,進一步展現熊去氧膽小檁鹼(HTD1801)的療效與安全性
June 5, 2024 09:00 HKT/SGT
HighTide Therapeutics Presents Analyses of Phase 2a MASH Study at the 2024 International Liver Congress, Reinforcing and Further Characterizing the Efficacy and Safety of Berberine Ursodeoxcyholate (HTD1801)
Mar 3, 2023 09:48 HKT/SGT
“天然分子” 的葫蘆裡,給慢病埋的什麼藥?
Mar 3, 2023 09:47 HKT/SGT
“天然分子” 的葫芦里,给慢病埋的什么药?
More news >>
Copyright © 2024 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Cookies Policy | Privacy Policy | Disclaimer | Terms of Use | RSS
US: +1 214 890 4418 | China: +86 181 2376 3721 | Hong Kong: +852 8192 4922 | Singapore: +65 6549 7068 | Tokyo: +81 3 6859 8575