VIDEO: Interim INTEGRIS-PSC trial results ‘promising’ in primary sclerosing cholangitis
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BOSTON — Healio spoke with James L. Boyer, MD, FACEP, about interim results from the phase 2a INTEGRIS-PSC trial presented at The Liver Meeting, which showed bexotegrast reduced biomarkers of liver fibrosis vs. placebo.
The ongoing phase 2 study is assessing bexotegrast in patients with primary sclerosing cholangitis and suspected liver fibrosis, and evaluating its safety, tolerability and effects on enhanced liver fibrosis scores and N-terminal type III collagen propeptide.
“This trial used three different drug doses — 40, 80 and 160 mg — and all three of those doses reduced those two biomarkers below the level of placebo, suggesting that fibrosis was slowed by the drugs,” Boyer, Ensign Professor of Medicine and emeritus director of the Liver Center at Yale School of Medicine, said.
He also noted that the results presented from the ongoing study were only from a 12-week period, but the safety profile was “promising.”
Reference:
- Hirschfield GM, et al. Oral v6/V1 integrin inhibition in primary sclerosing cholangitis: 12-week interim safety and efficacy analysis of INTEGRIS-PSC, a phase 2a trial of bexotegrast. Presented at: The Liver Meeting; Nov. 10-14, 2023; Boston (hybrid meeting).
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