HighTide Therapeutics Inc., a clinical-stage biopharmaceutical company, announced today the publication of multiple abstracts highlighting positive Phase 2 clinical data with HTD1801 in patients with primary sclerosing cholangitis (PSC) and nonalcoholic steatohepatitis (NASH). The data will be presented at the American Association for the Study of Liver Disease (AASLD) Liver Meeting 2021, being held virtually November 12-15, 2021.

“We are excited to present new HTD1801 clinical data in both PSC and NASH,” said Liping Liu, PhD, Founder and Chief Executive Officer of HighTide. “These additional analyses provide further insight into the potential benefit of HTD1801 for chronic liver diseases for which there remains great unmet need.”

PSC Abstracts

Oral Presentation: 14 November, Parallel 15: 1:00 – 2:40 PM EST

“Proof of Concept Study of HTD1801 (Berberine Ursodeoxycholate) in Patients with Primary Sclerosing Cholangitis Not Previously Exposed to UDCA” (publication number 107) — Gideon M. Hirschfield; Lisa Forman; Bertus Eksteen; Nadege Gunn; Vinay Sundaram; Charles Landis; Stephen A. Harrison; Anita Kohli; Cynthia Levy; Adrian M. Di Bisceglie; Kris V. Kowdley

HTD1801 demonstrated clinically meaningful improvements in biochemical markers of cholestasis and liver injury in subjects with PSC and no prior UDCA usage.

Poster Presentation

“Effects of HTD1801 (Berberine Ursodeoxycholate) in Subjects with Primary Sclerosing Cholangitis Previously Exposed to UDCA” (publication number 1267) — Kris V. Kowdley; Lisa Forman; Leigh A. MacConell; Gideon M. Hirschfield

Treatment with HTD1801 for 18 weeks improved biochemical markers of cholestasis and liver injury in subjects with PSC including those previously exposed to UDCA.

NASH Abstracts

Oral Presentation: 14 November, Parallel 21: 6:30 – 8:00 PM EST

“Reduction in Liver Fat Content with HTD1801 (Berberine Ursodeoxycholate) is Closely Associated with Improved Glycemic Control, Weight Loss, and Reduced ALT” (publication number 140) — Stephen A. Harrison; Nadege Gunn; Guy Neff; Anita Kohli; Joe Hirman; Adrian M. Di Bisceglie

HTD1801 significantly reduces liver fat content in patients with NASH and this effect is only partially explained by weight loss, improvements in HbA1c, and ALT reduction.

Poster Presentation

“Effects of HTD1801 (Berberine Ursodeoxycholate) on Non-Invasive Fibrosis Markers in Subjects with Presumed NASH and Type 2 Diabetes” (publication number 1191) — Stephen A. Harrison; Nadege Gunn; Guy Neff; Anita Kohli; Leigh A. MacConell; Rohit Loomba

Treatment with HTD1801 1000mg for 18 weeks was associated with improvements in some non-invasive fibrosis markers compared to placebo.

About HTD1801

HTD1801 is a first-in-class new molecular entity being developed for the treatment of primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), nonalcoholic steatohepatitis comorbid with type 2 diabetes mellitus (NASH & T2DM), and T2DM comorbid with nonalcoholic fatty liver disease (T2DM & NAFLD). An orally active ionic salt of berberine and ursodeoxycholic acid in development for chronic liver diseases, HTD1801 is currently being evaluated in Phase 2 trials in PSC, NASH and PBC.

HTD1801 has received Fast Track designation from the US FDA for both PSC and NASH, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in China’s National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project.

About HighTide Therapeutics

HighTide Therapeutics Inc. is a clinical-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutics for chronic gastrointestinal, metabolic, and CNS disorders, with a focus on areas of high unmet medical need and lack of effective treatment options. For additional information, please visit https://hightidetx.com.

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