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Intercept Announces Ocaliva Effective for PSC
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Intercept Pharmaceuticals announced today that a phase 2 trial of Ocaliva for primary sclerosing cholangitis met its primary endpoint in reducing alkaline phosphatase compared with placebo, according to a press release.
“We believe we’ve established a clear proof of concept for Ocaliva [obeticholic acid] as a potential treatment in PSC, a second cholestatic liver disease,” Mark Pruzanski, MD, president and CEO of Intercept Pharmaceuticals, said during a press conference. “As a result, we now have increased confidence that Ocaliva has an extensive opportunity in cholestatic liver diseases beyond PBC and further underscores our views that indications such as PSC and others represent a sizeable, long-term market opportunity.”
The AESOP trial was a 24-week, double-blind, placebo-controlled trial including 77 patients with PSC who received either 1.5 mg to 3 mg of obeticholic acid, 5 mg to 10 mg of obeticholic acid, or placebo. Compared with a 1% increase of alkaline phosphatase in the control group, both groups who received obeticholic acid treatment had a mean reduction of 22% (P < .05).
The researchers observed that mild to moderate pruritus, which occurred in all three arms, was the most common adverse event. Incidence and severity of pruritus increased with obeticholic acid treatment in a dose-dependent manner. One patient in the 1.5 mg to 3 mg group and three patients in the 5 mg to 10 mg group discontinued treatment due to pruritus. However, according to Pruzanski, 59 of the remaining 61 patients chose to participate in the ongoing two-year long term and safety extension trial.
“We look forward to sharing the complete results from AESOP with the hepatology community at an upcoming scientific congress,” David Shapiro, MD, chief medical officer of Intercept, said in a press release. “We believe these data warrant further investigation and look forward to speaking with PSC thought leaders and regulators to help inform our future development plans.” – by Talitha Bennett
Reference: Intercept Second Quarter 2017 Financial Results Conference Call. Accessed July 31, 2017. www.interceptpharma.com.