Date: 2017-07-31
Type of
information: Results
phase: 2
Announcement: results
Company: Intercept Pharmaceuticals (USA - NY)
Product: obeticholic acid (OCA)
Action
mechanism:
- farnesoid X receptor agonist. Obeticholic acid (OCA) is a bile acid analog and a first-in-class farnesoid X receptor (FXR) agonist being developed for primary biliary cirrhosis (PBC), NASH and other chronic liver indications.
Disease: primary sclerosing cholangitis
Therapeutic
area: Autoimmune diseases - Liver diseases - Hepatic diseases
Country: Austria, Belgium, France, Germany, Netherlands, Norway, Sweden, UK
Trial
details:
- AESOP is a Phase 2 randomized, double-blind, placebo-controlled, dose-finding evaluation of the efficacy and safety of 24 weeks of treatment with obeticholic acid (OCA) compared to placebo in 77 patients with PSC. The primary endpoint of the AESOP trial is the LS mean change in serum alkaline phosphatase (ALP) levels, as compared to placebo. Patients with well-controlled irritable bowel disease (IBD) at baseline were permitted to enroll in the AESOP trial and patients receiving ursodeoxycholic acid (UDCA) treatment at baseline (approximately 50% of patients) were permitted to continue on a stable dose. (NCT02177136)
Latest
news:
- • On July 31, 2017, Intercept Pharmaceuticals announced that the Phase 2 AESOP trial evaluating obeticholic acid for the treatment of patients with primary sclerosing cholangitis (PSC) met its primary endpoint. Patients who initiated obeticholic acid 5 mg with the option to titrate to 10 mg achieved a statistically significant reduction in alkaline phosphatase as compared to placebo (p<0.05). The primary endpoint of the study was the change in alkaline phosphatase levels relative to placebo at week 24 for the obeticholic acid 5 — 10 mg group.
| (U/L) |
Placebo (N = 25) |
OCA 1.5-3 mg (N = 25) |
OCA 5-10 mg (N = 26) |
| Mean Baseline ALP |
563 |
423 |
429 |
| Least Squares (LS) Mean Change from Baseline in ALP at Week 12 |
-53 |
-57 |
-135* |
| LS Mean Change from Baseline in ALP at Week 24 |
-27 |
-105 |
-110*† |
| LS Mean Percent Change from Baseline at Week 24 |
+1% |
-22%* |
-22%* |
- * p<0.05
† Primary endpoint was ALP change for OCA 5-10 mg compared to placebo at week 24.
- Pruritus is a common symptom of PSC and was the most common adverse event observed in the AESOP trial, occurring in 46%, 60% and 67% of patients in the placebo, OCA 1.5 — 3 mg and OCA 5 — 10 mg groups, respectively. Pruritus severity increased with OCA treatment in a dose-dependent manner. One (4%) patient in the OCA 1.5 — 3 mg group and three (12%) in the 5 — 10 mg group discontinued treatment due to pruritus compared to none with placebo. Other treatment emergent adverse events were similar across all three arms and the proportion of patients completing the double-blind period was similar across treatment groups (84%, 76% and 81% for placebo, OCA 1.5-3 mg and OCA 5-10 mg, respectively). Of these patients, 59 of 61 (97%) chose to participate in the LTSE phase.
- Intercept now looks forward to present complete results from this trial at an upcoming scientific congress.
Is
general: Yes
