Expert Interview
Discussing the recent data from the Phase 2a INTEGRIS-PSC Clinical Trial of Pliant's Bexotegrast in Patients with Primary Sclerosing Cholangitis
Ticker(s): PLRXInstitution: Yale University
- Academic hepatologist, Associate Professor of Medicine (Digestive Diseases) and Director, Yale Viral Hepatitis Program.
- Treats patients with chronic liver diseases including the entire spectrum from cirrhosis, liver failure, and post-transplant; Approximately 5-10% of his patients have chronic pruritus symptoms, 200 patients with biopsy-proven NASH and a larger cohort of NAFLD, and 70 patients with PBC/PSC.
- Has served on the national steering committees for large observational cohort studies for liver disease and has published over 100 papers in the area of GI and liver diseases.
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?
Added By: slingshot_insightsHow do the observed increases in bexotegrast's total and unbound plasma concentrations with dose impact its therapeutic potential?
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?
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?
Added By: slingshot_insightsGiven the stabilization of liver chemistry levels in bexotegrast-treated patients, how might this impact the long-term prognosis of PSC patients?
Added By: slingshot_insightsThe 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?
Added By: slingshot_insightsPruritus is a common symptom in PSC patients. How significant is the dose-dependent reduction in the Itch Numerical Rating Scale observed with bexotegrast treatment?
Added By: slingshot_insightsDr. 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?
Added By: slingshot_insightsBased 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?
Added By: slingshot_insightsAre You Interested In These Questions?
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