Positive Long-Term Data from INTEGRIS-PSC Phase 2a Trial Demonstrates Tolerability and Efficacy of Bexotegrast at 320 mg’Pliant Therapeutics recently reported favorable long-term results from its INTEGRIS-PSC Phase 2a trial, showcasing that Bexotegrast at a dosage of 320 mg was well tolerated over a treatment period extending up to 40 weeks. Notably, the treatment did not result in any severe or serious adverse events related to the drug. Additionally, Bexotegrast displayed maintained antifibrotic and anti-cholestatic activities as evidenced by multiple clinical measures.
Study Overview’
The INTEGRIS-PSC Phase 2a trial was designed to evaluate the safety, tolerability, and efficacy of Bexotegrast in patients with primary sclerosing cholangitis (PSC). Specifically, the subset of data reviewed focuses on the long-term administration of a 320 mg dose over a period of up to 40 weeks.
Key Findings’
’Tolerability’: An examination of patient responses over the 40-week period indicated that Bexotegrast at the 320 mg dosage was well tolerated. No treatment-related severe or serious adverse events were reported.
’Antifibrotic Activity’: Bexotegrast demonstrated continued antifibrotic efficacy, as evaluated through biomarkers and clinical measures relevant to liver fibrosis. This suggests a potential in slowing the progression of fibrotic changes in patients with PSC.
’Anti-Cholestatic Activity’: In addition to antifibrotic properties, Bexotegrast exhibited sustained anti-cholestatic effects. This was observed through various biochemical markers, indicating a reduction in cholestasis severity and associated symptoms.
Conclusion’
The INTEGRIS-PSC Phase 2a trial results affirm that Bexotegrast at a dose of 320 mg is not only well tolerated but also benefits patients by demonstrating ongoing antifibrotic and anti-cholestatic activities. Taken together, these findings provide a promising outlook for the long-term use of Bexotegrast in managing PSC. Further studies will be necessary to confirm these results and explore the long-term efficacy and safety profile in a larger cohort.
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