Alizyme colitis drug clears Phase II trial

Alizyme of the UK has reported positive preliminary results in a PhaseII trial of COLAL-PRED (prednisolone sodium metasulphobenzoate) in patients with active ulcerative colitis. The product makes use of Alizyme's proprietary technology designed to deliver drugs directly to the colon after ingestion of a capsule.

In the study, 37 patients with mild-to-moderate UC received either 40mg or 60mg COLAL-PRED each day for four weeks, after which the dose was tapered off over the next three weeks. The results indicate improvements on the Disease Activity Index and Physician's Global Assessment scales in 63% of the 60mg dose group and 35% of those on 40mg. A clinical remission was achieved in 31% and 6%, respectively, which Alizyme said was a comparable result to that seen with conventional prednisolone formulations and dosing regimens.

Importantly, monitoring of morning plasma cortisol levels indicated that patients receiving COLAL-PRED did not suffer significant systemic exposure to prenisolone, reaffirming the low tendency of the formulation to cause steroid-related side effects.