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HighTide Therapeutics to Present Data on Improvements in Liver Fat Content and Fibroinflammation Based on MRI Response in Patients with NASH and T2DM treated with Berberine Ursodeoxycholate (HTD1801) at The Liver Meeting® 2023

October 12, 2023

ROCKVILLE, MD and SHENZHEN, CHINA, October 11, 2023 — HighTide Therapeutics, Inc. (“HighTide”), a biopharmaceutical company developing novel multifunctional multi-targeted therapies for metabolic and digestive diseases, announces that data related to its berberine ursodeoxycholate (HTD1801) development program will be presented at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD), taking place November 10-14, in Boston, Massachusetts.

Assessment of MRI Response in Patients with NASH and T2DM Treated with HTD1801 (Berberine Ursodeoxycholate) for 18 Weeks

Authors: Nadege Gunn, Stephen A. Harrison, Guy Neff, Abigail Flyer, Alexander Liberman, Leigh MacConell

Abstract Number: 2708-A

Presentation Type: Poster

Presentation Date and Time: Saturday, November 11, 2023, 1:00 PM (EST)

A poster titled “Assessment of MRI Response in Patients with NASH and T2DM Treated with HTD1801 (Berberine Ursodeoxycholate) for 18 Weeks” will be presented based on further analyses from the Phase 2 NASH Study HTD1801.PCT012 (NCT03656744). Previous studies have demonstrated that achieving at least 30% relative reduction in liver fat content (LFC) as determined by magnetic resonance imaging (MRI)- proton density fat fraction (PDFF) or an improvement in fibroinflammation as determined by at least an 80 ms reduction in MRI-derived corrected T1 (cT1) are both correlated with improvements in liver histology (≥2-point improvement in the non-alcoholic fatty liver disease [NAFLD] activity score and no worsening of fibrosis). HTD1801 is a first-in-class gut-liver anti-inflammatory metabolic modulator. The purpose of this analysis was to assess the characteristics and on-treatment changes in patients who achieved either of these MRI response criteria. Twice as many patients achieved an MRI response with HTD1801 compared to placebo after 18 weeks of treatment (52% vs 24%). Furthermore, 22% of all patients randomized to HTD1801 vs 12% randomized to placebo achieved both the LFC and cT1 criteria. These improvements in MRI-based endpoints are indicative that HTD1801 may have the potential to improve the histologic features of NASH and fibrosis. Critically, improvements were observed with HTD1801 treatment in liver biochemistry and key cardiometabolic parameters in both patients who did and did not achieve these response criteria.

“We are thrilled to be presenting these data at AASLD,” said Dr. Leigh MacConell, Chief Development Officer of HighTide. “This abstract provides further evidence of the promising potential for HTD1801 for the treatment of NASH and gives us greater confidence in our ongoing biopsy-based Phase 2B CENTRICITY study (NCT05623189). Moreover, not only do we see improvements in MRI criteria associated histologic improvements, but also in many parameters that are associated with the comorbidities and metabolic dysfunction that impact these patients.”

About HighTide Therapeutics

HighTide Therapeutics, Inc. is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional multi-targeted therapies with poly-indications across metabolic and digestive diseases with significant unmet medical needs. The company is developing multiple clinical assets, including therapy for nonalcoholic steatohepatitis (NASH), type 2 diabetes (T2DM), severe hypertriglyceridemia (SHTG), primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). Berberine ursodeoxycholate (HTD1801), the company’s lead drug candidate, 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 under the 13th Five-Year Plan for Major Technology Project.

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