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Intercept Reports First Patient Dosing of Obeticholic Acid + Bezafibrate in the P-II Study for the Treatment of Primary Biliary Cholangitis

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Intercept Reports First Patient Dosing of Obeticholic Acid + Bezafibrate in the P-II Study for the Treatment of Primary Biliary Cholangitis

Intercept Reports First Patient Dosing of Obeticholic Acid + Bezafibrate in the P-II Study for the Treatment of Primary Biliary Cholangitis

Shots:

  • The first patient has been dosed in a P-II study evaluating a fixed-dose combination of OCA + BZF in ~60 patients with PBC who have not achieved an adequate biochemical response to UDCA across the US
  • The study will evaluate the reduction in ALP @12wks., followed by a long-term safety extension while the 2EPs include safety, tolerability & other biochemical markers of disease progression i.e., AST, GGT, ALT, and bilirubin
  • The second P-II study is currently ongoing in the EU to evaluate the different dosing regimens of OCA + BZF while the P-I study is also undergone in the US in healthy adult patients. Additionally, all three studies help to  identify the dose selection and study design for a P-III trial

Ref: Globe Newswire | Image: Intercept

Click here to­ read the full press release 

Neha

Neha Madan is a content writer at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots.

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