Isotechnika, a biopharmaceutical company, has reported that its Essence Phase III trial of voclosporin in moderate to severe psoriasis patients successfully met the primary endpoint of superiority to placebo in the proportion of patients achieving a score of ‘clear’ or ‘almost clear’ in the static physician’s global assessment at 12 weeks of treatment.
In the voclosporin arm 35% of patients achieved a ‘clear’ or ‘almost clear’ static physician’s global assessment (SPGA) score at 12 weeks compared to 6% of patients receiving placebo (p (less than) 0.001). Another widely used measure of efficacy for psoriasis treatments is the reduction in the psoriasis area and severity index (PASI).
In the voclosporin arm 43% of patients at 12 weeks and 46% of patients at 60 weeks achieved a 75% reduction in PASI (PASI-75) and 67% of patients at 12 weeks and 68% of patients at 60 weeks achieved a 50% reduction in PASI (PASI-50). In addition to the placebo control, the study also included an active comparator arm, cyclosporine. The secondary endpoint of non-inferiority to cyclosporine, which had a score of ‘clear’ or ‘almost clear’ in SPGA in 53% of patients, was not met.
Voclosporin demonstrated positive outcomes on other pre-specified secondary endpoints at 24 weeks reported in a descriptive manner. In each of these safety parameters, the advantages observed in the voclosporin arm at week 24 versus the cyclosporine arm were maintained through to week 60 of the study, the company said.
In particular, the cardiorenal risk associated with voclosporin appears to be reduced as the incidence of triglyceride elevation, hypertension and renal adverse effects were all lower than for cyclosporine. In addition, voclosporin showed clear improved safety over cyclosporine with regards to headache, pareasthesia, and hirsutism.
Robert Foster, president and CEO of Isotechnika, said: While we would have liked to have seen ‘non-inferiority’, we are pleased with the risk-benefit of voclosporin and consider it a valuable treatment option. This is true particularly in light of the reported lower 12 week PASI-75 scores of the market leading treatment, etanercept.