Phase III AKP01 study of Akvano shows efficacy in plaque psoriasis.- Lipidor

Lipidor AB reports positive topline results of its AKP01 Phase III clinical study, using Akvano (calcipotriol spray) against mild to moderate plaque psoriasis. The randomised 277-patient study achieved its primary endpoint demonstrating therapeutic equivalence to comparator measured as reduction of PASI score. Both Lipidor's AKP01 and the comparator had a statistically significantly better efficacy compared to the placebo. The study design consisted of 8 weeks treatment, applied twice daily, 3 mg/cm2 dosing, males and non-pregnant females, three arms with 119 patients in the AKP01 group, 119 patients in the Calcipotriol ointment group and 39 in the placebo group. Baseline inclusion criteria were mild to moderate plaque type of psoriasis, stable for six months, with Psoriasis Area and Severity Index (PASI) greater than 5, involving 5-10% of body surface area on arms, legs and trunk. Assessments were made at baseline, week 2, 4 and 8. The primary endpoint was percentage change in PASI from baseline to the end of completed treatment. Therapeutic equivalence to comparator was measured by comparing the 95 % confidence interval with the equivalence interval of -10, 10%. Topline results of the analysis of the study demonstrated therapeutic equivalence to comparator in reducing psoriasis symptoms according to the PASI scale. AKP01 was well tolerated through 8 weeks of study drug administration. The incidence of adverse events was low in all treatment groups. All adverse events were mild or moderate, with no serious adverse events reported. Evaluation of secondary endpoints as well as more detailed analysis of the study results will now be started.