ROCKVILLE, MD and SHENZHEN, CHINA, October 25, 2022 — HighTide Therapeutics, Inc. (“HighTide”), a clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced that two abstracts related to its HTD1801 development program will be presented at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD), in Washington, DC (November 4 – 8, 2022).

A poster presentation titled “Effects of HTD1801 on the Gut Microbiota in Three Rodent Models of Non-alcoholic Fatty Liver Disease and Diabetes” will show how HTD1801 stimulates positive changes in gut microbiota. Emerging evidence supports the bidirectional relationship between intestinal microbiota and liver health. Dysbiosis has been associated with the pathogensis and progression of multiple metabolic diseases and chronic inflammatory liver diseases, including nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). These  data showing positive changes in gut microbiota are encouraging and provide another mechanism of action underlying the beneficial effects of HTD1801 in liver and metabolic diseases.

Additionally, a poster presentation titled “Greater Biochemical Improvements With HTD1801 in Patients With PSC and Elevated Baseline Alkaline Phosphatase” will demonstrate how PSC patients treated with HTD1801 exhibited improvement in alkaline phosphatase (ALP). ALP is a key biomarker of cholestasis and liver injury, and serum levels are positively associated with degree of disease severity and risk. The data show that treatment with HTD1801 was associated with overall improvement in markers of cholestasis and liver injury. Importantly, benefit on these liver markers was observed in PSC patients with significantly elevated ALP, a population considered to be at high risk for disease progression.

Presentations at the Liver Meeting® 2022 include:

Effects of HTD1801 on the Gut Microbiota in Three Rodent Models of Non-alcoholic Fatty Liver Disease and Diabetes

Authors: Ru Bai, Meng Yu, Liping Liu, Adrian M. Di Bisceglie

Abstract Number: 4301

Presentation Type: Poster

Presentation Date and Time: Monday, November 7, 2022, 1:00 PM (EST)

Greater Biochemical Improvements With HTD1801 in Patients With PSC and Elevated Baseline Alkaline Phosphatase

Authors: Lisa Forman, Kris V. Kowdley, Bertus Eksteen, Nadege Gunn, Vinay Sundaram, Charles Landis, Stephen A. Harrison, Cynthia Levy, Alexander Liberman, Adrian Di Bisceglie, Gideon M. Hirschfield

Abstract Number: 4711

Presentation Type: Poster

Presentation Date and Time: Monday, November 7, 2022, 1:00 PM (EST)

“We are very pleased to share these data,” said Liping Liu, Ph.D., founder and Chief Executive Officer of HighTide. “Both abstracts support our business strategy in that they provide further evidence of the promising potential for HTD1801 and the treatment of NASH and PSC. The microbiome data demonstrate another positive mechanism of action attribute for HTD1801 and the ALP data demonstrate effectiveness even in more severe disease.”

About HighTide Therapeutics

HighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of innovative 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 nonalcoholic steatohepatitis (NASH), type 2 diabetes (T2DM), 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