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  2. Clinical Trials
CymaBay Initiates IDEAL, a Phase 3 Placebo-Controlled, Randomized Study of Seladelpar
Clinical Trials, PBC News  |   August 14, 2023

CymaBay Initiates IDEAL, a Phase 3 Placebo-Controlled, Randomized Study of Seladelpar

The 52-week IDEAL study aims to enroll 75 patients with PBC who have an incomplete response or intolerance to ursodeoxycholic acid (UDCA), in each case with ALP greater than the
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Ipsen and GENFIT announce positive Phase 3 trial data
Clinical Trials, PBC News  |   June 30, 2023

Ipsen and GENFIT announce positive Phase 3 trial data

Ipsen and GENFIT announce positive topline data from the pivotal ELATIVE Phase III trial. In the trial the efficacy and safety of elafibranor, an investigational dual α,δ PPAR agonist, is
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Fixed dose combination OCA/Bezafibrate positive interim Phase 2 study results.
Clinical Trials, PBC News  |   June 11, 2023

Fixed dose combination OCA/Bezafibrate positive interim Phase 2 study results.

Intercept Pharmaceuticals announces new data showing potential of Fixed-Dose Combination of OCA and Bezafibrate to normalize multiple biomarkers in PBC to be featured in podium presentation at EASL Congress June
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Linerixibat GLISTEN phase 3 study now enrolling
Clinical Trials, PBC News  |   May 31, 2023

Linerixibat GLISTEN phase 3 study now enrolling

The GLISTEN clinical trial is investigating a potential new treatment specifically for PBC itch and is now enrolling patients worldwide.  In Canada, the study is currently enrolling in Toronto, Ontario.
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Fixed-dose combination OCA/Bezafibrate granted orphan drug designation by FDA
Clinical Trials, PBC News  |   May 18, 2023

Fixed-dose combination OCA/Bezafibrate granted orphan drug designation by FDA

Intercept Pharmaceuticals is investigating a fixed-dose combination of OCA and bezafibrate for the potential treatment of individuals with PBC. Clinical trials are underway to establish safety and efficacy. OCA, a
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Pacific Study Phase 2 now enrolling in Canada
Clinical Trials, PBC News  |   March 1, 2023

Pacific Study Phase 2 now enrolling in Canada

The Phase 2 PACIFIC study will enroll approximately 58 patients with moderate-to-severe pruritus due to PBC or PSC.   Now enrolling in Canada, see what’s involved here. The study comprises a
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Clinical Trials, PBC News  |   February 18, 2023

Evidence of efficacy of OCA for PBC patients

A study published in the Gastroenterology (September 2022) showed that people receiving OCA for primary biliary cholangitis (PBC) in a clinical trial setting had greater transplant-free survival to patients with
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Clinical Trials, PBC News  |   August 19, 2022

Seladelpar – Phase 2 results published

“This study demonstrates the significant anticholestatic effects of seladelpar in patients with PBC who had suboptimally responded to UDCA or were UDCA intolerant. Evidence of seladelpar’s dose-dependent efficacy, safety, and
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Clinical Trials, PBC News  |   May 24, 2022

Clinical studies of Seladelpar – new analysis

New analyses of clinical studies of Seladelpar were presented during Digestive Disease Week® (DDW) in San Diego on May 23, 2022.   The three presentations were: “Seladelpar Treatment of Patients With
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Setanaxib TRANSFORM study now enrolling
Clinical Trials, PBC News  |   April 7, 2022

Setanaxib TRANSFORM study now enrolling

The purpose of this clinical research study is to evaluate the effects of an investigational product (setanaxib) as a potential additional treatment for PBC. The study is now enrolling in
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