Shire reports safety, tolerability of potential drug for PSC

Shire plc announced first quarter financial results for 2016, including preliminary results from its CAMEO trial which investigated the safety and tolerability of its potential drug SHP625 for the treatment of primary sclerosing cholangitis.

The phase 2 clinical trial is an open-label study where adults with PSC were dosed with SHP625 (Shire) for 14 weeks to determine the safety and efficacy tolerability of the drug and compare it with results of previous trials. No concerns were observed related to primary endpoints. The financial report states there was no significant reduction in alkaline phosphatase or other liver parameters. However, Shire later pointed out that the study’s 14-week duration was not designed to measure these secondary endpoints fully.

Although the trial did not improve ALP, it did reduce serum bile acids from baseline, the report said. In addition, reductions in pruritus, as measured by ItchRO score, were observed with “the magnitude of the effect being consistent with what has been observed in SHP625 studies with other patient populations,” according to the report.

In a statement given to Healio.com/Hepatology from Shire plc, a spokesperson said the company is still evaluating results of the trial.

“PSC is a chronic liver disease that slowly damages bile ducts inside and outside the liver and is strongly associated with inflammatory bowel disease, mainly ulcerative colitis. Shire continues to evaluate findings from the SHP625 program for the treatment of PSC. Shire continues to analyze the totality of the SHP625 data to determine an appropriate path forward,” the statement said.