VIDEO: GS-9674 demonstrates safety, efficacy for PSC

SAN FRANCISCO — In this exclusive video perspective from The Liver Meeting 2018, Rob Myers, MD, senior director of the liver diseases therapeutic area at Gilead Sciences, discusses positive phase 2 outcomes of GS-9674 for the treatment of primary sclerosing cholangitis.

“We’re very encouraged by these results and are currently engaging with regulators to discuss a path forward to future study of GS-9674,” Myers told Healio Gastroenterology and Liver Disease.

The phase 2 study comprised 52 patients with large duct PSC who received GS-9674 — a farnesoid X receptor (FXR) agonist — for 12 weeks.

At 12 weeks, patients had significant reductions in serum alkaline phosphatase (–21%; P = .029), gamma-glutamyl transferase (–30%; P < .001), alanine aminotransferase (–49%; P = .009), aspartate aminotransferase (–42%; P = .019), and tissue inhibitor of metalloproteinase-1 (–8.2%; P = .063) compared with placebo.

“Quite gratifying to us was the fact that the compound was safe and well-tolerated in these patients and, in fact, was associated with a lower incidence of itching or pruritus compared with placebo treatment,” Myers said.

Gilead is also investigating GS-9674 for treatment of patients with NASH.

Reference:

Trauner MH, et al. Abstract 0043. Presented at: The Liver Meeting 2018; Nov. 9-13, 2018; San Francisco.

Disclosure: Myers is the senior director of the liver diseases therapeutic area at Gilead Sciences.