Biotech Values

[DewDiligence]

ICPT starts phase-2 trial of OCA + Lipitor in NASH patients:

http://finance.yahoo.com/news/intercept-pharmaceuticals-announces-initiation-prospective-120500643.html

CONTROL has been designed as a randomized, double-blind, placebo-controlled Phase 2 clinical trial. The trial is expected to enroll 80 NASH patients who are naive to statin therapy or have undergone a statin washout, and will include a 16-week double-blind phase followed by an optional two-year long-term safety extension phase.

CONTROL will assess lipid and subfraction changes every four weeks over the course of the study as follows:

• The first four weeks will evaluate three doses of OCA (5 mg, 10 mg, 25 mg) or placebo with no concomitant statin therapy

• At week four, all patients will receive the lowest approved dose of atorvastatin (10 mg) and will titrate to the next highest prescribed dose of atorvastatin (20 mg) at week eight

• At week 12, physicians will be free to titrate the dose of atorvastatin at their discretion through to the end of study

This phase-2 trial is motivated by the adverse lipid profile observed for OCA patients in the FLINT study and by ICPT’s contention that such lipid changes can readily be managed with statins.