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Expert Interview

Slingshot members are talking to an expert! The topic is:

A Second Look: Discussing the recent data from the Phase 2a INTEGRIS-PSC Clinical Trial of Pliant's Bexotegrast in Patients with Primary Sclerosing Cholangitis

Ticker(s): PLRX

Who's the expert?

Institution: Massachusetts General Hospital 

  • Director of Hepatology and Liver Center & Vice Chief of Gastroenterology at Massachusetts General Hospital.
  • Treats 75 patients with PSC and 400 patients with NASH.
  • Research interest in liver disease pathogenesis in persons with HIV, viral hepatitis, and defining biomarkers and gene signatures for persons at high risk for liver disease progression and liver cancer.

Interview Questions
Q1.

The primary endpoint of the INTEGRIS-PSC trial was the evaluation of bexotegrast's safety and tolerability. Can you comment on the significance of the reported 94% completion rate over 12 weeks with no severe or serious adverse events?

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Q2.

How do the observed increases in bexotegrast's total and unbound plasma concentrations with dose impact its therapeutic potential?

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Q3.

The trial highlighted a treatment effect on the ELF score across all bexotegrast dose groups. How does this finding align with the current understanding of liver fibrosis progression in PSC?

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Q4.

With significant reductions observed in all three components of the ELF score at the 160 mg dose, what implications does this have for the broader treatment landscape of PSC?

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Q5.

Given the stabilization of liver chemistry levels in bexotegrast-treated patients, how might this impact the long-term prognosis of PSC patients?

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Q6.

The preliminary MRI imaging showed small increases in MRI relative enhancement across all dose groups. How does this suggest improved hepatocyte function, and what is its clinical relevance?

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Q7.

Pruritus is a common symptom in PSC patients. How significant is the dose-dependent reduction in the Itch Numerical Rating Scale observed with bexotegrast treatment?

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Q8.

 Dr. Cynthia Levy mentioned the compelling data from the INTEGRIS-PSC trial. In your opinion, how might bexotegrast change the treatment paradigm for PSC, especially considering the current lack of pharmaceutical treatment options?

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Q9.

Based on the INTEGRIS-PSC trial results, what are the next steps for bexotegrast in its clinical development, and how do you envision its role in the future management of PSC?

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