ChemoCentryx presents positive results for Crohn’s disease drug

Clinical results demonstrate that the investigational candidate, Traficet-EN, was well tolerated and showed activity in the treatment of patients with active Crohn’s disease, the company said.

Patients enrolled in the phase II clinical trial were randomized to receive a once-daily 250 mg capsule of Traficet-EN or placebo for 28 days. Both Crohn’s Disease Activity Index (CDAI) scores and C-reactive protein (CRP) levels were measured at baseline and on study days 8, 15 and 29.

Among a defined subgroup of 39 patients identified as having more active disease, 58% of patients in the Traficet-EN group experienced a 70 point or greater drop in CDAI scores compared to 31% of those who received placebo. Importantly, Traficet-EN’s anti-inflammatory activity was demonstrated by a decrease in CRP levels, which serve as a systemic marker of inflammation, of 11 mg/L in the treatment group compared to placebo.

Traficet-EN’s anti-inflammatory activity was demonstrated by a decrease in CRP levels, which serve as a systemic marker of inflammation, of 11 mg/L in the treatment group compared to placebo.

“Patients with active disease reported significant improvement in their condition when treated with Traficet-EN compared to those in the control group,” said Pirow Bekker, vice president, medical and clinical affairs of ChemoCentryx.

According to Bekker, current research has shown that CDAI scores of 250 and above, combined with elevated CRP serum levels at baseline, help to identify patients with actual Crohn’s disease and may thereby reduce the high placebo response rate frequently observed in Crohn’s disease clinical trials. The company is currently using these parameters as enrollment criteria in its ongoing long-term clinical study, known as PROTECT-1, which will evaluate Traficet-EN’s ability to induce response or remission, as well as at the drug’s potential as maintenance therapy.