Incyte reports positive results from two Phase IIa psoriasis studies

Results from the first study (Study 201), a Phase IIa dose-escalation trial involving 28 patients, demonstrated that INCB18424 was well tolerated at all doses and significantly improved overall total lesion score and each component of the total lesion score (thickness, erythema and scaling) as compared to vehicle.

In this trial, INCB18424 at 1.5% twice daily also showed improvements in total lesion scores that were similar to the currently approved therapies, Dovenex and Diprolene.

The second study (Study 202) is an ongoing open-label sub-total inunction 28-day Phase IIa trial designed to evaluate the safety and pharmacokinetics of INCB18424 at increasing coverage levels of total body surface area (BSA).

Results from Study 202 demonstrated that INCB18424 was well tolerated in the first cohort of patients involving five subjects who applied the compound to not less than 2% or more than 7% of their BSA. Data from the first cohort of this trial also showed that INCB18424 improved lesion thickness, erythema and scaling, and reduced overall treated lesion area as compared to the overall untreated lesions.

A three-month Phase IIb trial involving approximately 300 psoriasis patients with mild to moderate disease is scheduled to begin in October 2008. The Phase IIb trial will evaluate three doses of topical INCB18424 applied once-daily as compared to vehicle. The primary endpoints for the trial include change in total lesion score of all psoriatic lesions, and safety and tolerability as assessed by monitoring signs and symptoms and through collection of clinical laboratory and blood samples.